Which Drug Patents have Expired in 2018?

 In IP Analytics

The Generic drugs industry is one of the fastest growing industries of this century. Valued at USD 200 Billion in 2015, the global market for generic drugs is expected to reach USD 380 Billion by 2021, according to a report published by Zion Market research.  In the US alone, Generic drug market is a multi-billion dollar industry, with generic drugs accounting for the majority of the total prescriptions dispensed in united states.

A major reason behind the growth in the generic drug market is expiring blockbuster drug patents, which opens us paths for pharmaceutical companies to manufacture the generic version of the original product. However, manufacturing generics is a challenge on its own as companies need to be careful to avoid infringing on patents around the drug. To avoid such instances, it is important to conduct a drug study prior to venturing into manufacturing the generic variant.

As of 2019, a lot of generic drugs are speculated to hit the market as some major blockbuster drug patents are about to hit their expiry date in 2018. But manufacturing generics around some of these patents can be a real challenge given the exclusivity around these patents.

Which drug patents and how are they exclusive? – you ask. We got the answers. Below listed are 26 drugs whose patents are to hit their expiry date in 2018. You can read about a specific drug by clicking on the link below or read the whole list. The choice is yours.

Here are the Drugs that got Expired in 2018:

1. Acanya Gel

2. Adcirca (Tadafil)

3. Ampyra (Dalfampridine)

4. Apidra (Insulin glulisine)

5. Cialis(Tadalafil)

6. Fentora (fentanyl)

7. Finacea (azelaic acid)

8. Follistim (Follitropin beta)

9. Fortesta (Testosterone)

10. Levitra/Staxyn (vardenafil)

11. Lexiva (Fosamprenavir)

12. Lotronex (Alosetron)

13. Lyrica (Pregabalin)

14. Makena (Hydroxyprogesterone)

15. Promacta (Eltrombopag)

16. Rapaflo (Silodosin)

17. Remodulin (Treprostinil)

18. Sensipar tablet (Cinacalcet)

19. Spiriva (Tiotropium)

20. Symbicort (Budesonide/Formoterol)

21. Tekamlo (Aliskiren)

22. Tekturna HCT (Aliskiren/HCTZ)

23. Tikosyn (Dofetilide)

24. Treximet (Naproxen/Sumatriptan)

25. Tyvaso (Treprostinil)

26. Vesicare (Solifenacin)

1. Acanya Gel

Launched by Dow Pharmaceuticals on October 23, 2008, prescription medication Acanya Gel comprises two ingredients which help in curing acne – clindamycin and benzoyl peroxide. The drug is prescribed for the treatment of moderate and mild inflammatory breakouts and severe cases of acne. Moreover, the drug is also helpful for the cure for blackheads and bumps. This is a prescription only drug, prescribed to those affected with acne and above-mentioned skin disorders.

Ever since its launch in the market, the drug has proven to be of utmost value to its parent company. The market sales annually for Acanya as of July 2017 is estimated to be $57 million. Given the success attained by Acanya Gel in the market, many pharmaceutical companies wish to be at the top of the game by launching the generic version of the drug in the market.

FDA has already approved the generic version of the drug. However, it might not be available for commercial use given the exclusivity and the patent around this drug.

How and why is Acanya exclusive?

Being a combination medication, Acanya is a drug that offers the best of both ingredients used in it. Rather than just benzoyl peroxide being used or clindamycin, a combination of both works better because they hit all the factors causing acne at once, eradicating them in one go. Clindamycin helps in killing the breakout-causing bacteria – Propionibacterium acne and also helps in reducing the inflammation. The cooling effect of benzoyl peroxide helps in preventing bacteria from becoming antibiotic-resistant.

Adcirca is helpful f or people suffering from pulmonary arterial hypertension (PAH). The drug is an approved therapy that enables the reduction of symptoms of PAH while increasing the exercising abilities of patients.

The drug was developed by Eli Lilly, which holds the marketing rights to distribute the product all across Europe. However, United Therapeutics has the license to market and produce the product in the United States. Adcirca is also sold by the name Cialis and helps in the treatment of benign prostatic hypertrophy and erectile dysfunction.

According to a source, Adcirca is one of the major revenue sources for United Therapeutics generating a quarter of total revenue annually. In 2016 alone, Adcirca generated USD 372 Million in sales, an approximate 23% of the company’s total revenue.

How and why is Adcirca exclusive?

Primarily, PAH implies the narrowing of the blood vessels (vasoconstriction) in the lungs. This results in increased blood pressure. Oxygen is not transported to the body, which results in poor blood flow. One major reason behind this is the low levels of a molecule called cGMP which takes care of the relaxation of the smooth muscles of the artery walls. Adcirca acts as an inhibitor of the enzyme phosphodiesterase-5(PDE-5) which is the cause of the breakdown of cGMP. When PDE-5 is blocked, it means that cGMP is not cleared rapidly which results in its accumulation in the body. The higher the level of cGMP, the greater is the relaxation of smooth muscles of the arteries. This leads to the vasodilation and a reduction of blood pressure, improving the transport of oxygen around the body and the patient’s ability to exercise.

Coming down to exclusivity, the reasons Adcirca would prevent entry of any generics any soon is the presence of two patents related to Adcirca that would expire in 2020.  Which patents are these and what can be done to avoid infringement on these patents while developing a generic? If you’d like more information, click here.

3. Ampyra (Dalfampridine)

Developed by Acorda Therapeutics, Ampyra (dalfampridine) is a 10mg extended-release tablet. Ampyra has been approved by the United States Food and Drug Administration (FDA) to help patients with multiple sclerosis (MS) in walking. The drug has been proven to demonstrate an increase in walking speed for all the people suffering from the disease.

Ampyra belongs to a class of drugs called potassium chain blockers and helps in the treatment of Multiple sclerosis. The drug stands out as it is the first and the only branded prescription of MS therapy that has been approved by FDA. The popularity of the drug in the United States knows no bounds – as more than 400,000 people in the US and approximately 2.5 million people worldwide are suffering from multiple sclerosis. The sales of the drug in the market touched its peak in 2016 when it made $493 million which amounted to 95% of Acorda’s total revenue.

How and why is Ampyra exclusive?

Being used for the treatment of multiple sclerosis, Ampyra acts as a potassium chain blocker. This is also known as 4-aminopyridine (4-AP) when it is developed using a compounding pharmacy. The drugs exclusivity with regards to curing MS lies in its ability to block the tiny pores (also known as potassium channels) which lies on the surface of the nerve fibers. When this happens, there is an improvement in the ability of the nerve fibers especially those which have been damaged due to demyelination, for conducting electrical impulses and nerve signals.

4. Apidra (Insulin glulisine)

Developed by Sanofi-Aventis, Apidra is an injection which consists of insulin glulisine. As commonly known, insulin is a hormone that helps in lowering the levels of glucose in the body. Having insulin glulisine as its composition, the fast-acting insulin begins to show its results in the body after 15 minutes of taking the injection, peaks in one hour and keeps working for two to four hours. The drug is used to cure children and adults with diabetes mellitus. It is widely used for the treatment of Type one or two diabetes in adults and Type one diabetes in children who are at least 4 years of age.

The generic version of the drug has not been approved as of now. Neither is the equivalent of the drug presently available in the market.  The popularity of Apidra all across the globe is seamless. The sales reached a peak of €367 Million in 2016 and €377 Million in 2017. The drug made its parent company a ton of profit mainly because of the exclusivity and the drug patents surrounding it.

How and why is Apidra exclusive?

Apidra is human insulin that is used to lower the levels of blood glucose in the body. The insulin glulisine used in the drug is created with the help of recombinant DNA technology – a laboratory strain of Escherichia Coli (K 12) which is nonpathogenic. The insulin glulisine used in the drug is different from human insulin with regards to its structural formula. The asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid.

5. Cialis (Tadalafil)

The drug, Cialis (tadalafil) helps in the relaxation of the muscle of the blood vessels and increases the flow of blood to the particular areas of the body. Cialis has been used for the treatment of erectile dysfunction (impotence) and benign prostatic hypertrophy (enlarged prostate).

The drug was a part of the first and foremost treatments for erectile dysfunction and for more than a decade this has been used by men throughout the globe because of its ability to demonstrate excellent results. The company, Eli Lilly was the original manufacturer for Cialis and has a patent for the product since 1997. The drug was primarily used for the treatment of heart diseases, but with the help of clinical trials, it was observed that Cialis also helps in the treatment of erectile dysfunction. In 2003, FDA gave Eli Lilly the approval to license the product in the market for the treatment of erectile dysfunction. The sales of the drug reached up to $597.4 million just after a couple of years post its launch.

How and why is Cialis exclusive?

Cialis does not enable a man to be sexually aroused until and unless he is not sexually aroused mentally. When a man is aroused, the erectile tissue of the penis releases nitric oxide in the body, which in turn results in the stimulation of an enzyme which produces a messenger called cyclic guanosine monophosphate (cGMP) which helps in the relaxation of the smooth muscle cells. What happens because of this is that the arteries in the penis tend to dilate and blood flows into the penis more easily. The erectile tissue which is responsible for the sexual arousal fills with blood. Cialis works by maintaining the level of cGMP in the blood.

6. Fentora (Fentanyl)

Being an opioid pain medication, Fentora buccal tablets are used for the treatment of “breakthrough” cancer pains which cannot be controlled with the help of other medications. This is primarily prescribed for patients who regularly take moderate to large amounts of opioid pain medication.

Fentora belongs to a class of drugs known as opioid narcotic analgesics. It affects the brain and changes the way the body feels and responds to pain. It is absolutely not advisable to use the drug in case of migraines and headaches. Fentora was developed by the company Cephalon and ever since its release in the market, the drug has performed exceedingly well. As of 2015, 6.5 million fentanyl prescriptions were dispensed solely in the United States. Also, during the first nine months of 2016, 4.55 million prescriptions were distributed, according to the IMS health data. As of now, no other drug is known which is therapeutically as effective as Fentora.

How and why is Fentora exclusive?

The drug comprises Fentanyl which is an extremely strong narcotic that is known to be extremely effective for the treatment of pain. The risks of this drug are known widely. Fentora functions by attaching itself to the opioid receptors in the body to produce pain relieving effects throughout the body. The potential for abuse of this drug is extremely high and is not given to people without a prescription. It is only given to patients who are tolerant to opioid medication. Misuse of Fentora can be extremely dangerous.

7. Finacea (azelaic acid)

Finacea is a topical gel comprising azelaic acid which is a naturally occurring acid. This acid enables the skin to renew itself more quickly which thereby results in the reduction of the formation of pimples and blackheads. By helping remove the bacteria which causes acne and rosacea, Finacea is used for the treatment of mild and moderate rosacea, which is a skin condition that causes red eruptions, primarily on the nose and on the cheeks.

The drug was developed by Bayer HealthCare and was approved by the Food and Drug Administration in 2015. After its release in the market, Finacea soon became a success. The drug’s net worth as of 2017 amounted to approximately, $54 Million. This has been made possible because of the drugs exclusivity and the patents.

Note: The authorized generic version of the drug has been approved which means that it can now be distributed in the market as a generic drug under a private label.

How and why is Finacea exclusive?

The gel comprises an active ingredient known as azelaic acid. This acid is responsible for the reduction of keratin surface skin cells which have the tendency to block pores. This helps to unblock glands which secrete sebum and the pores. With the help of this, the sebum escapes and blackheads and spots are not formed. The acid also kills the bacteria which is responsible for acne –  Propionibacterium acnes. This bacteria feeds on the sebum produced in the body. By producing waste products and fatty acids, and irritating the glands, they become inflamed causing spots. Azelaic acid inhibits the formation of these bacteria by taking away their food source so that they do not grow in the body.

8. Follistim (Follitropin beta)

Follistim is a medication which comprises of the follicle-stimulating hormone (FSH). The medication is used for the treatment of fertility-related problems that occur in both women and men. With regards to women, it helps in the stimulation of healthy ovaries which are responsible for the production of healthy eggs in a female body. Follitism is used with HCG which helps in easily releasing the mature egg and its growth. When it comes to men, it helps in the stimulation of healthy testes which are responsible for the production of sperms. In this case, too, it is used in combination with HCG.

The drug was developed by Merck Sharp & Dohme B.V. and has played a vital part in the treatment of fertility-related problems throughout the globe ever since. The medication has witnessed ups and downs with regards to its positioning in the market.  From having a net worth of $481 million in 2013 its value has come down to $232 Million as of 2017. Presently, there is no other medication which is as therapeutically equivalent to Follistim in the market.

How and why is Follistim exclusive?

The medication consists of follicle stimulating hormone (FSH) which is manufactured with the help of recombinant DNA technology. The cartridge is prefilled premixed recombinant gonadotropin. The pen allows women to a specific dose of subcutaneous injection. For people undergoing assisted reproductive technology (ART) program, the drug has proved to be extremely advantageous.

9. Fortesta (testosterone)

As a prescription medicine that contains testosterone, which is a natural male hormone necessary for the proper functioning of the body, it is used for the treatment of several conditions in men which stem from the lack of natural testosterone. It is essential to keep in mind here the fact that this gel, in no way enhances the aesthetic performance of the male body and should never be used to do this else it might lead up to grave consequences.

This androgel is slightly more popular than the other drugs available in the market for treating the lack of testosterone. The drug was developed by Endo Pharmaceuticals Inc and ever since its inception, Fortesta performed exceedingly well in the market and reached a net worth of $52 Million in 2015.

The generic version of this drug has been approved by the Food and Drug Administration, though this not necessarily mean that the drug will be available for commercial use in the market due to the patent and drug exclusivity.

How and why is Fortesta exclusive?

Fortesta is an androgel which comprises 2% testosterone in its overall chemical formulation. For the male body to function at its optimum, testosterone is a hormone which plays a vital role. When the body witnesses the lack of the hormone, too many symptoms surface which develop a deep impact on the person – physically and emotionally. This affects the quality of life of the person severely. The main symptom which surfaces when the testosterone drops too low in the body is erectile dysfunction. Fortesta helps men in combating these symptoms by injecting fortesta directly into their bloodstreams. The advantages of using this drug include a sharper mind, a better overall mood, and reduced body fats.

10. Levitra/Staxyn (vardenafil)

Vardenafil is a drug which is prescribed to patients suffering from sexual function problems (impotence or erectile dysfunction-ED). The medication works by increasing the blood flow to the penis in a combination with sexual stimulation and enables men to keep up with the erection. A common misconception is that the drug protects against sexually transmitted diseases such as Hepatitis B, HIV, Gonorrhea and syphilis, which it does not.

The drug was developed by May & Baker Pharmaceuticals Pvt Ltd and ever since its inception in the market, the drug has been performing extremely well. As of now, there is no therapeutically available equivalent of Vardenafil available in the market. The drug was approved by the Food and Drug Administration in August 2003.

How and why is Vardenafil exclusive?

This is an oral medication which is used for the treatment of erectile dysfunction or impotence. In such cases, men are unable to achieve the penile erection, which is caused due to the filling of the penis with blood. The enlargement of the penis because of the sexual stimulation taking place in the body leads to the release of nitric oxide in the penis. The nitric oxide released into the body produces an enzyme called cGMP which is responsible for increasing and decreasing the size of blood vessels carrying blood to the penis. Vardenafil prevents the enzyme PDE-5 from killing cGMP so that the erection lasts longer.

11. Lexiva (Fosamprenavir)

The antiviral medication Lexiva (fosamprenavir) is a drug which is used to prevent human immunodeficiency virus (HIV) from multiplying in the human body. The medication is used globally for the treatment of acquired immunodeficiency syndrome (AIDS). It is prescribed for children who are at least 4 years of age as well as adults.

Lexiva (fosamprenavir) should not be misinterpreted for the cure of HIV or AIDS. This just prevents the virus from multiplying in the body.  The drug was developed by ViiV Healthcare, and ever since its inception in the market, Lexiva has established a place for itself. For the year 2015 alone, Lexiva had record sales of $71.6 Million in the United States.

The generic version of Lexiva has been approved by the Food and Drug Administration, but this does not necessarily indicate for the product to be available in the market for commercial use due to the drug patent and exclusivity.

How and why is Lexiva exclusive?

The prodrug Fosamprenavir, because of its chemical structure is hydrolyzed to amprenavir with the help of the cellular phosphates present in the gut epithelium as and when it is absorbed. Amprenavir inhibits the HIV-1 protease. The replication of the human immunodeficiency virus in the body, HIV protease cleaves the viral polypeptide products of the Gag-pol and Gap genes to form the essential structural proteins. Amprenavir’s functionality comes into play now – it binds itself to the active site of HIV-1 protease, thereby preventing the formation of immature non-infectious viral particles.

12. Lotronex (alosetron)

Lotronex (alosetron) is a drug that helps in blocking serotonin in the intestines. By doing so, the drug helps in slowing down the movement of stools through the intestine. The medication is used for the treatment of severe, chronic irritable bowel syndrome (IBS), primarily occurring in females. The drug does not perform well in the case of men. While the drug is not a cure for IBS, it helps it cease for a period of time.

The drug was developed by Sabela Pharmaceuticals to relieve the suffering caused because of irritable bowel syndrome in women. The generic version of the drug has been approved by the FDA, and as of now, there are many drugs equivalent to Lotronex. Ever since its release in the market, the drug has earned Sabela a lot of revenue. According to sources, the drug made $50 million from October 2015 to September 2016 alone.

How and why is Lotronex exclusive?

It is scientifically proven that the discomfort caused in females due of irritable bowel syndrome is because of the abnormal activity of the muscles of the intestine, or to be more precise, because of the nerves which control the muscles. The chemical messenger which is responsible for the coordination of the activity of the nerves in the intestine is serotonin. Lotronex (alosetron) works by blocking a particular kind of serotonin receptor known as the 5-HT3 receptor. This receptor is responsible for contraction of the intestinal muscles, controlling pain sensation and the release of fluid in the intestine. Lotronex helps the situation by blocking 5-HT3 receptors which thereby, reduces the impact of serotonin.

13. Lyrica (pregabalin)

Being an antiepileptic drug, Lyrica is also used as an anticonvulsant by many people. The drug functions by slowing down impulses in the brain which are responsible for the occurrence of seizures. Lyrica (pregabalin) is also responsible for affecting the pain signals which are sent to the entire nervous system. The drug is also used for the treatment of fibromyalgia and is used to relieve pain which is caused by nerve damage in people suffering from diabetes.

Apart from this, the drug plays a vital role in the treatment of pain caused due to herpes zoster (postherpetic neuralgia) and spinal cord injury. The drug was developed by Pfizer to help patients suffering from seizures. As of now, there is no single therapeutically available equivalent of the drug available in the market. The drug is known to have performed exceedingly well in the market. Studies indicate that it made $5.2 Billion (worldwide) and $228.9 million in the United States alone in 2014.

How and why is Lyrica exclusive?

The pain of Fibromyalgia is a result of the nerve-related changes taking place in the body because of which the nerve cells tend to fire off too many signals. When a person gets brain signals more than the required amount, it tends to make the person overly sensitive to the stimuli which are otherwise not so painful in day-to-day life. Researchers as of now are not exactly sure as to how Lyrica helps in decreasing the number of nerve signals, but laboratory research indicates that the drug calms down overly sensitive nerve signals. This helps in alleviating the pain in patients suffering from fibromyalgia.

14. Makena (Hydroxyprogesterone)

A type of progestin, Makena (hydroxyprogesterone) is a man-made form of a natural female hormone called progesterone. The drug is primarily used to lower the risk of premature birth in women who have already suffered the loss of a premature baby. It is a common misconception that this medication stops premature labor which has already begun in the body when actually that is not the case, Also, the drug is not advisable for women who are pregnant with more than one baby (triplets, twins, etc).

The drug was developed by AMAG Pharmaceuticals to help women by preventing premature deliveries. Presently there is no therapeutically available equivalent of Makena available in the market. Studies show that the drug secured a place for itself in the market by making $400 million as of 2017.

How and why is Makena exclusive?

As an injection which comprises hydroxyprogesterone, Makena lowers the risk of having the baby before time (a preterm birth). The chemical composition and the ways through which these drug functions are known already.  Studies indicate that progesterone helps in creating a healthy environment for the baby in the uterus for the last half of the pregnancy.

15. Promacta (eltrombopag)

 The drug, Promacta (eltrombopag) is a man-made protein which helps in increasing the production of platelets (blood-clotting cells) in the body. The drug helps in lowering the chances of bleeding by increasing the number of platelets in the body. Promacta is used for the prevention of bleeding episodes, for example, people suffering from chronic immune thrombocytopenic purpura (ITP), which is a bleeding condition caused because of the lack of platelets in the blood. The drug is also used to prevent bleeding in people undergoing chronic hepatitis C who are treated with the help of interferon.

The drug was developed by Novartis and ever since its launch in the market, it has performed extremely well. According to reports, the drug made Novartis $385 million in just the first half of 2017. Presently, there is no therapeutically available equivalent of the drug available in the market.

How and why is Promacta exclusive?

The class of drugs, namely thrombopoietin (TPO) acts as receptor agonists and Promacta falls under this category. The medications which fall under the same class of drugs function in a similar way and the drugs are often used for the treatment of similar conditions. Eltrombopag, for instance,  is a drug which works by increasing the cells present in the bone marrow. It helps the cells to make more platelets, thereby lowering the risk of bleeding.

16. Rapaflo (Silodosin)

Rapaflo helps in the relaxation of the muscles present in the prostate and bladder neck, thereby making it easier to urinate. This drug is used to improve urination in men suffering from an enlarged prostate. When a man suffers from an enlarged prostate, it results in pain, frequent and difficult urination.

Rapaflo was created by the company Allergan and has been widely popular throughout the globe for the treatment of BPH. The drug has made great sales in the market. Sources report that Rapaflo made $228.7 Million in 2015 alone.

The generic version of the drug has been approved by the Food and Drug Administration, but it does not necessarily indicate that now the drug will be available in the market due to existing patents and exclusivity.

How and why is Rapaflo exclusive? 

Rapaflo is a drug which is used in for the treatment of men who have the symptoms of an enlarged prostate gland, which is commonly known as benign enlargement of the prostate (BPH). This is a problem which takes place in men as and when they begin to age. The gland is located below the bladder and as and when the prostate gland becomes larger some of the muscles in the gland become tight and get in the way of the tube that drains urine through the bladder. This causes the need to urinate more often than required and a feeling of not being to empty the bladder in one go. The drug plays an essential part in the treatment of these symptoms by relaxing the muscles in the prostate and in the opening to the bladder. Either the urinary flow is increased or the symptoms are decreased.

17. Remodulin (Treprostinil)

Responsible for the dilation (or widening) of the arteries, Remodulin is a medication which decreases the amount of blood clotting that takes place in the body. Due to its function of widening the arteries, this drug helps in lowering the blood pressure in the pulmonary artery that leads from the heart to the lungs.

The drug plays a crucial part in the treatment of pulmonary arterial hypertension (PAH) which thereby leads to the improvement in the ability to exercise and prevents patient’s conditions from getting worse. The drug was developed by United Therapeutics and ever since its launch in the market, it has improved the quality of life of many people suffering from pulmonary arterial hypertension.

The generic version of this drug has been approved by the Food and Drug Administration (FDA) though this not necessarily imply that the drug is commercially available in the market. With regards to the monetary aspects, the drug secured a place for itself by making $614 million in 2016.

How and why is Remodulin exclusive?

Pulmonary arterial hypertension is a progressive condition which damages the lungs, heart and the blood vessels. Due to PAH, the body is unable to produce prostacyclin, which is a natural substance responsible for keeping the blood vessels open and in a proper working condition. When this happens, the body is unable to find the required amount of oxygen which it requires. Remodulin is similar to prostacyclin which the body lacks. The drug helps in curing symptoms such as PAH, which includes shortness of breath and fatigue.

18. Sensipar tablet (cinacalcet)

By reducing the amount parathyroid hormone (PTH), phosphorus and calcium, Sensipar is used for the treatment of hyperthyroidism, which is a condition related to the overactive functioning of the parathyroid glands in the body. The drug is used for the treatment of people who are on long-term dialysis for kidney disease. The drug was developed by Amgen and ever since its inception, it has helped patients get out hyperthyroidism. Currently, there is no therapeutically available equivalent of Sensipar available in the market. Due to it immense popularity the drug made $344 million in sales internationally in 2017 alone.

How and why is Sensipar exclusive?

Sensipar belongs to a class of medications known as calcimimetic agents. The drug is used for the treatment of overactive parathyroid glands for people suffering from kidney diseases and is currently undergoing dialysis treatment. By reducing the amount of calcium present in the blood, the drug helps patients with hyperthyroidism and parathyroid cancer who are unable to undergo surgery. The parathyroid glands present in the body works in order to control the levels of calcium, parathyroid hormones and phosphorous in the body. In case the parathyroid gland present in the body produces an excess of parathyroid hormone, the levels of calcium present in the blood increases. Sensipar controls the parathyroid hormone by regulating the calcium and the phosphorus levels present in the blood.

19. Spiriva (Tiotropium)

As a bronchodilator which relaxes muscles in the airways resulting in an increased airflow to the lungs, Spiriva is a medication which is used to prevent bronchospasm (narrowing airways in the lungs) in case of adults suffering from a chronic obstructive pulmonary disease which includes bronchitis and emphysema.

The drug is also used in the prevention of asthma attacks in adults and children who are at least 6 years old. The drug is used primarily to prevent symptoms such as shortness of breath and wheezing which is caused mainly because of ongoing lung diseases like bronchitis or emphysema. Spiriva was developed by Boehringer Ingelheim – a pharmaceutical company which has provided medical solutions globally. Ever since the drug was launched in the market, it has made tremendous sales. In 2016 alone, Spiriva made 3 billion euros in sales for its parent company.

As of now, there is no therapeutically available in the United States.

How and why is Spiriva exclusive?

Spiriva comprises an active ingredient called tiotropium, which is an antimuscarinic or anticholinergic bronchodilator. This active ingredient present in the drug helps by opening the airways, thereby making it easier to breathe. In the lungs, it blocks receptors known as muscarinic which are present in the muscles that surround the airways. Usually, a natural chemical acts on these receptors which results in the contraction. With regards to chronic obstructive lung diseases (COPD), the airways tend to become narrow. Spiriva blocks the muscarinic receptors and thereby stops the action of acetylcholine in it helping people with COPD easily breathe.

20. Symbicort (budesonide/formoterol)

Symbicort is a drug comprising a combination of budesonide and formoterol and used in the prevention of bronchospasm for people suffering from a chronic obstructive pulmonary disease (COPD) and asthma. The medication is prescribed to both adults and children who are at least 6 years of age. The drug should only be used if the asthma is severe and cannot be controlled by other medications.

The drug was developed by the company AstraZeneca to help patients suffering from Asthma globally. Presently, there is no therapeutically available equivalent of the drug available in the market. Symbicort is a blockbuster drug in every right, having had made $2.9 Billion in sales in 2016 alone.

How and why is Symbicort exclusive?

Irritated and swollen airways is a persistent problem for people suffering from COPD. Due to the swelling in the lungs, the airways tend to become very narrow which in turn, results in the decrease of air getting into the lungs. The continuous irritation present results in the muscles which surround the airways to tighten up in bronchospasm. Symbicort comprises two kinds of medicines which are responsible for the improvement in this condition – budesonide and formoterol. Budesonide is a kind of drug called inhaled corticosteroid, which is an anti-inflammatory drug that helps in reducing the amount of swelling by allowing more air to pass through. Formoterol, on the other hand, is a long-acting beta agonist (called “LABA”) that works by relaxing the muscles which surround the airways.

21. Tekamlo (Aliskiren)

Tekamlo is primarily used for the treatment of high blood pressure (hypertension). Having a combination of aliskiren and amlodipine, the drug acts by reducing the substances in the body that narrows the blood vessels and increases the pressure. Tekamlo also acts as a calcium channel blocker which helps in the widening of the blood vessels thereby improving the blood pressure. The drug was developed by Novartis with an aim to help patients suffering from high blood pressure globally.

How and why is Tekamlo exclusive?

High blood pressure is a symptom that increases the workload of the arteries and the heart. If it is persistent in individuals, the heart and the blood vessels fail to function properly which leads to the damage to the heart, brain, and kidneys. If the situation leads to this, it can result in a stroke, kidney failure or heart failure. When the blood pressure is lowered in the body, the chances of getting a stroke and heart attack is reduced.

By being a renin inhibitor, Aliskiren blocks the enzyme in the body which produces a kind of substance which makes the blood vessels tighten. Due to this ability of Aliskiren, the blood pressure in the body is lowered and the oxygen flow in the body is increased. The drug also functions as a calcium chain blocker which affects the movement of calcium into the cells of the blood vessels. This helps in the relaxation of the blood vessels and increases the supply of oxygen and blood to the heart.

22. Tekturna HCT (Aliskiren/hctz)

A combination of aliskiren and hydrochlorothiazide, Tekturna HCT is also used for the treatment of high blood pressure (hypertension). Hydrochlorothiazide is a water pill which prevents the body from excessive salt intake which thereby results in fluid retention. Aliskiren, on the other hand, is an anti-hypersensitive medication that plays its part by decreasing substances in the body which narrows the blood vessels and increases the blood pressure. The drug was developed by Norden Pharmaceuticals with an aim to help patients suffering from high blood pressure to get rid of the same. As of 2015, the drug made $154 Million in sales. Presently, there is no therapeutically available equivalent of Tekturna available in the market.

How and why is Tekturna exclusive?

Aliskiren works by causing the blood vessels to present in the body to become narrow, thereby lowering the blood pressure. This is done by blocking a specific kind of chemical which narrows the blood vessels. When this chemical is blocked, Aliskiren relaxes and widens the blood vessels which lets the blood to flow smoothly without any kind of hindrances. HCT is a water pill which eliminates sodium, popularly known as salt present in the body. Together, Aliskiren and HCT lower the blood pressure.

23. Tikosyn (dofetilide)

These days many individuals suffer from several types of irregular heartbeat. This can be serious at times and the other times, fatal. The condition where an irregular heartbeat arises is known as atrial fibrillation. Tikosyn is a medication which is used for restoring the regular heart rhythm of an individual. In medical terms, it is also known as an antiarrhythmic drug.

Treating an irregular heartbeat is essential as it decreases the risk of blood clots in the body and reduces the chances of heart attacks and strokes. The drug was developed by Pfizer, one of the worlds best pharmaceutical companies for the treatment of people suffering from an abnormal heartbeat. A generic version of Tikosyn has been approved by the Food and Drug Administration (FDA), but this does not necessarily imply that the drug is available for commercial use in the market.

How and why is Tikosyn exclusive?

 Tikosy helps people suffering from an abnormal heartbeat. The drug tends to block the rapid component of the delayed rectifier which is the outward potassium current (Ikr). When this happens, the refractory period of the atrial tissue increases and it renders the heartless susceptible to A-Fib signals thus helping normalize the heartbeat.

24. Treximet (Naproxen/sumatriptan)

As a tablet comprising sumatriptan and naproxen, Treximet is used for the treatment of migraine headaches. The tablet works by narrowing the blood vessels around the brain and reduces the substances in the body with are the cause of certain kind of migraine symptoms.

Treximet also functions as an anti-inflammatory drug (NSAID) and reduces hormones which cause pain and inflammation in the body. It is a misconception that the drug helps in the reduction of headaches, but the fact is that it is only used for the treatment of a headache which has already begun. Pernix Therapeutics has developed this drug with an end goal to enhance the quality of lives of people suffering from migraine attacks. Currently, there is no therapeutically available equivalent of the drug which is available in the market.  The drug has set a place for itself by making tremendous sales in the market. Studies show that Treximet made $13.8 Million in the first quarter of 2017 alone.

How and why is Treximet exclusive?

Treximet belongs to a class of drugs called triptan. The sumatriptan part of the drug helps reduce the swelling of the blood vessels around the brain and is beneficial in decreasing the other pain-causing substances. The naproxen sodium present in the drug plays a vital role to reduce migraines by blocking the production of chemicals known as prostaglandins which causes inflammation – one of the major reasons why the headaches when someone is suffering from a migraine.

25. Tyvaso (treprostinil)

Treprostinil is a drug which is primarily used for the treatment of pulmonary arterial hypertension (PAH). The drug is used for curing patients with NYHA Class II-IV symptoms by diminishing the symptoms which are related to exercise. The drug can be used as either an intravenous or subcutaneous infusion. The medication is also available in the market in tablet and inhaler forms. The drug is known to diminish the rate of clinical deterioration.

The drug was developed by United Therapeutics in order to help people suffering from PAH across the globe. As of now, there is no therapeutically available equivalent of the drug available in the market. As soon as Treprostinil was launched in the market, the drug made huge sales. In the first half of 2017 alone, Treprostinil made $192 Million in sales.

How and why is Treprostinil exclusive?

The drug works by widening the blood vessels in the lungs and it also ensures that the platelets present in the blood does not coagulate and there are no unwanted blood clots present in the body. The functionality of the drug is such that it lowers the blood pressure in the pulmonary artery that leads from the heart to the lungs. By doing so, it improves the patient’s ability to exercise efficiently.

26. Vesicare (solifenacin)

Vesicare is a drug which is used to treat symptoms related to an overactive bladder. The cases of these include urinary urgency, urge incontinence (wetting that results from an unstoppable urge to urinate) and urinary frequency. Vesicare helps individuals by working on a way to relax the bladder. It helps in reducing spasms and the frequency of urination.

The drug was developed by Astellas Pharma to help patients suffering from overactive bladder  (OAB). Vesicare showed its presence in the market when it made US$530 million in 2016. A generic version of this drug has been approved by the Food and Drug Administration (FDA) though it does not imply that the drug will be available for commercial use in the market.

How and why is Vesicare exclusive?

The medication comprises an active ingredient known as solifenacin succinate which is an antimuscarinic (or anticholinergic). The primary role of this ingredient lies in muscle relaxation. Due to the action of the dug, the involuntary muscle present in the bladder tends to relax a little. The wall of the urinary bladder is known as detrusor muscle. The muscle sometimes causes spasms which are uncontrollable because of which people feel the urge to urinate again and again. Vesicare relaxes the detrusor muscle of the bladder. It blocks the muscarinic (or cholinergic) receptors which are present on the muscle surface. When this happens, a natural chemical called acetylcholine to act upon these receptors. Normally when it does, the muscle tends to contract. All in all, the need to urinate becomes less because of these abilities of the drug.

Conclusion

We have listed 26 drugs whose patents are to hit their expiry date in 2018. However, manufacturing generics is still not as easy as there exists IP protecting these drugs. If you are thinking of manufacturing a generic, it would be a wiser move to conduct a drug study to understand the patents surrounding the drugs. Because it is always better to make informed decisions.

Related Study: Generic Drug Of (Mecitentan) Pulmonary Artery Hypertension – Hurdles Before Pharma Companies

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