In 2025, 98 drugs across Europe will lose market exclusivity, opening multi-billion-euro opportunities for generic and biosimilar manufacturers. These expirations span oncology, immunology, neurology, infectious diseases, and veterinary medicine, setting the stage for one of the most competitive years in European pharma.
From blockbusters like Dupixent and Tecentriq to life-saving therapies such as Spinraza and Lutathera, the loss of exclusivity (LOE) will redefine access, pricing, and competitive dynamics.
Key Therapeutic Areas Affected by 2025 Expiries
Oncology: Expirations for Tecentriq (Roche), Kisqali (Novartis), and Lutathera (AAA) could impact the cancer drug pricing.
Immunology & Inflammation: Dupixent (Sanofi) and Tremfya (Janssen) represent blockbuster-level opportunities for biosimilars.
Rare Diseases: Spinraza (Biogen) for SMA and Brineura (BioMarin) face expiry, though their complexity makes biosimilar entry challenging.
Infectious Diseases: HIV combinations, antivirals for HBV/HCV, and antibiotics like Daptomycin Hospira open highly competitive generic spaces.
Drugs Losing Market Exclusivity in 2025
| Medicine name | Therapeutic area | Data Exclusivity Expiration date | Marketing authorisation holder/company name |
| Tacforius | Liver Transplantation; Kidney Transplantation | 8/12/2025 | Teva B.V. |
| Rabitec | 1/12/2025 | CEVA Santé Animale | |
| Bovilis Blue-8 | 21/11/2025 | Intervet International B.V. | |
| Zejula | Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms | 16/11/2025 | GlaxoSmithKline (Ireland) Limited |
| Elebrato Ellipta | Pulmonary Disease, Chronic Obstructive | 15/11/2025 | GlaxoSmithKline Trading Services Limited |
| Trelegy Ellipta | Pulmonary Disease, Chronic Obstructive | 15/11/2025 | GlaxoSmithKline Trading Services |
| Ontruzant | Stomach Neoplasms; Breast Neoplasms | 15/11/2025 | Samsung Bioepis NL B.V. |
| Zubsolv | Opioid-Related Disorders | 10/11/2025 | Accord Healthcare S.L.U. |
| VeraSeal | Hemostasis, Surgical | 10/11/2025 | Instituto Grifols, S.A. |
| Tookad | Prostatic Neoplasms | 10/11/2025 | STEBA Biotech S.A |
| Tremfya | Psoriasis | 10/11/2025 | Janssen-Cilag International NV |
| Ritonavir Mylan | HIV Infections | 9/11/2025 | Mylan S.A.S |
| Miglustat Gen.Orph | Gaucher Disease | 9/11/2025 | Gen.Orph |
| Nyxoid | Opioid-Related Disorders | 9/11/2025 | Mundipharma Corporation (Ireland) Limited |
| Nobivac LeuFel | 6/11/2025 | Virbac S.A. | |
| Dupixent | Dermatitis, Atopic; Prurigo; Esophageal Diseases; Asthma; Sinusitis | 26/09/2025 | Sanofi Winthrop Industrie |
| Lutathera | Neuroendocrine Tumors | 26/09/2025 | Advanced Accelerator Applications |
| Entecavir Accord | Hepatitis B, Chronic | 25/09/2025 | Accord Healthcare S.L.U. |
| Symtuza | HIV Infections | 21/09/2025 | Janssen-Cilag International NV |
| Tecentriq | Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Urologic Neoplasms; Breast Neoplasms; Small Cell Lung Carcinoma | 20/09/2025 | Roche Registration GmbH |
| Bavencio | Neuroendocrine Tumors | 18/09/2025 | Merck Europe B.V. |
| Lacosamide Accord | Epilepsy | 18/09/2025 | Accord Healthcare S.L.U. |
| Rydapt | Leukemia, Myeloid, Acute; Mastocytosis | 18/09/2025 | Novartis Europharm Ltd |
| Entecavir Mylan | Hepatitis B | 18/09/2025 | Mylan Pharmaceuticals Limited |
| Xermelo | Carcinoid Tumor; Neuroendocrine Tumors | 17/09/2025 | SERB SAS |
| Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | HIV Infections | 5/09/2025 | Mylan Pharmaceuticals Limited |
| Cuprior | Hepatolenticular Degeneration | 5/09/2025 | GMP-Orphan SA |
| Fotivda | Carcinoma, Renal Cell | 24/08/2025 | Recordati Netherlands B.V. |
| Imraldi | Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis | 24/08/2025 | Samsung Bioepis NL B.V. |
| Suvaxyn PRRS MLV | 24/08/2025 | Zoetis Belgium SA | |
| Kisqali | Breast Neoplasms | 22/08/2025 | Novartis Europharm Limited |
| Mavenclad | Multiple Sclerosis | 22/08/2025 | Merck Europe B.V. |
| Innovax-ND-IBD | 22/08/2025 | Intervet International B.V. | |
| Exzolt | 18/08/2025 | Intervet International B.V. | |
| Vepured | 17/08/2025 | Laboratorios Hipra, S.A. | |
| Vosevi | Hepatitis C, Chronic | 26/07/2025 | Gilead Sciences Ireland UC |
| Maviret | Hepatitis C, Chronic | 26/07/2025 | AbbVie Deutschland GmbH Co. KG |
| Insulin lispro Sanofi | Diabetes Mellitus | 19/07/2025 | Sanofi Winthrop Industrie |
| Veltassa | Hyperkalemia | 19/07/2025 | Vifor Fresenius Medical Care Renal Pharma France |
| Trimbow | Pulmonary Disease, Chronic Obstructive | 17/07/2025 | Chiesi Farmaceutici S.p.A. |
| Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | HIV Infections | 17/07/2025 | Zentiva k.s. |
| Kyntheum | Psoriasis | 17/07/2025 | LEO Pharma A/S |
| Blitzima | Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell | 13/07/2025 | Celltrion Healthcare Hungary Kft. |
| Reagila | Schizophrenia | 13/07/2025 | Gedeon Richter |
| Spherox | Cartilage Diseases | 10/07/2025 | CO.DON Gmbh |
| Oxervate | Keratitis | 6/07/2025 | Dompe farmaceutici s.p.a. |
| Besponsa | Precursor Cell Lymphoblastic Leukemia-Lymphoma | 28/06/2025 | Pfizer Europe MA EEIG |
| Clynav | 26/06/2025 | Elanco GmbH | |
| Erelzi | Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing | 23/06/2025 | Sandoz GmbH |
| Kevzara | Arthritis, Rheumatoid | 23/06/2025 | Sanofi Winthrop Industrie |
| Skilarence | Psoriasis | 23/06/2025 | Almirall S.A |
| Ucedane | Hyperammonemia; Amino Acid Metabolism, Inborn Errors | 23/06/2025 | Eurocept International BV |
| Prevomax | 19/06/2025 | Dechra Regulatory B.V. | |
| Rixathon | Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus | 15/06/2025 | Sandoz GmbH |
| Riximyo | Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis | 15/06/2025 | Sandoz GmbH |
| Febuxostat Mylan | Hyperuricemia; Arthritis, Gouty; Gout | 15/06/2025 | Mylan Pharmaceuticals Limited |
| Refixia | Hemophilia B | 2/06/2025 | Novo Nordisk A/S |
| Elmiron | Cystitis, Interstitial | 2/06/2025 | bene-Arzneimittel GmbH |
| Brineura | Neuronal Ceroid-Lipofuscinoses | 30/05/2025 | BioMarin International Limited |
| Spinraza | Muscular Atrophy, Spinal | 30/05/2025 | Biogen Netherlands B.V. |
| Trumenba | Meningitis, Meningococcal | 24/05/2025 | Pfizer Europe MA EEIG |
| Ivabradine Accord | Angina Pectoris; Heart Failure | 22/05/2025 | Accord Healthcare S.L.U. |
| Axumin | Prostatic Neoplasms; Radionuclide Imaging | 21/05/2025 | Blue Earth Diagnostics Ireland Ltd |
| Respiporc FLUpan H1N1 | 17/05/2025 | CEVA Santé Animale | |
| Zeleris | 15/05/2025 | CEVA Santé Animale | |
| Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) | Neuroblastoma | 8/05/2025 | Recordati Netherlands B.V. |
| Emtricitabine/Tenofovir disoproxil Krka d.d. | HIV Infections | 28/04/2025 | KRKA, d.d., Novo mesto |
| Cytopoint | 25/04/2025 | Zoetis Belgium SA | |
| Zulvac BTV | 25/04/2025 | Zoetis Belgium SA | |
| Natpar | Hypoparathyroidism | 24/04/2025 | Takeda Pharmaceuticals International AG Ireland Branch |
| Credelio | 23/04/2025 | Elanco GmbH | |
| Roteas | Stroke; Venous Thromboembolism | 19/04/2025 | Berlin-Chemie AG |
| Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) | Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors | 10/04/2025 | Leadiant GmbH |
| Jylamvo | Arthritis, Psoriatic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Psoriasis; Arthritis, Rheumatoid; Arthritis | 29/03/2025 | Therakind (Europe) Limited |
| Tadalafil Lilly | Erectile Dysfunction | 22/03/2025 | Eli Lilly Nederland B.V. |
| Xeljanz | Arthritis, Rheumatoid | 22/03/2025 | Pfizer Europe MA EEIG |
| Yargesa | Gaucher Disease | 22/03/2025 | Piramal Critical Care B.V. |
| Daptomycin Hospira | Soft Tissue Infections; Skin Diseases, Bacterial | 22/03/2025 | Pfizer Europe MA EEIG |
| Amgevita | Arthritis, Psoriatic; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Psoriasis; Crohn Disease; Arthritis, Rheumatoid | 21/03/2025 | Amgen Europe B.V. |
| Rolufta Ellipta (previously Rolufta) | Pulmonary Disease, Chronic Obstructive | 20/03/2025 | GlaxoSmithKline Trading Services Limited |
| Ledaga | Mycosis Fungoides | 3/03/2025 | Helsinn Birex Pharmaceuticals Ltd. |
| Truxima | Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Wegener Granulomatosis; Leukemia, Lymphocytic, Chronic, B-Cell; Microscopic Polyangiitis | 17/02/2025 | Celltrion Healthcare Hungary Kft. |
| Alecensa | Carcinoma, Non-Small-Cell Lung | 16/02/2025 | Roche Registration GmbH |
| Olumiant | Arthritis, Rheumatoid | 13/02/2025 | Eli Lilly Nederland B.V. |
| Vihuma | Hemophilia A | 13/02/2025 | Octapharma AB |
| Stronghold Plus | 8/02/2025 | Zoetis Belgium SA | |
| VarroMed | 2/02/2025 | BeeVital GmbH | |
| Zinplava | Enterocolitis, Pseudomembranous | 18/01/2025 | Merck Sharp & Dohme B.V. |
| Cystadrops | Cystinosis | 18/01/2025 | Recordati Rare Diseases |
| Suliqua | Diabetes Mellitus, Type 2 | 11/01/2025 | Sanofi Winthrop Industrie |
| Movymia | Osteoporosis | 11/01/2025 | STADA Arzneimittel AG |
| Vemlidy | Hepatitis B | 9/01/2025 | Gilead Sciences Ireland UC |
| Talmanco (previously Tadalafil Generics) | Hypertension, Pulmonary | 9/01/2025 | Viatris Limited |
| Coliprotec F4/F18 | 9/01/2025 | Elanco GmbH | |
| Fiasp | Diabetes Mellitus | 9/01/2025 | Novo Nordisk A/S |
| Terrosa | Osteoporosis | 4/01/2025 | Gedeon Richter Plc. |
| Afstyla | Hemophilia A | 4/01/2025 | CSL Behring GmbH |
| Darunavir Mylan | HIV Infections | 3/01/2025 | Mylan Pharmaceuticals Limited |
Tracking 98 expirations is only part of the story. To navigate effectively, pharma teams need visibility into the entire EMA approval and exclusivity landscape.
That’s why we’ve built the Elixir EMA Dashboard that gives you:
- Complete visibility into all EMA-approved drugs.
- Exclusivity timelines & expiry alerts by therapeutic area or company.
- Filters & benchmarks to identify where real market openings exist.
- Export-ready data to align R&D, regulatory, and market-access strategies.
By combining real-time dashboards with exclusivity foresight, Elixir enables companies to secure first-mover advantage in Europe’s evolving generics and biosimilars market.
