As healthcare budgets across Europe remain under pressure, 2026 marks an important turning point. Multiple high-cost medicines are scheduled to lose regulatory exclusivity, enabling future price competition and expanded patient access. Understanding which therapies are affected and when is essential for both policymakers and pharmaceutical manufacturers.
The article lists European drug exclusivities expiring in 2026. You can get the drug patent expiration list from 2026 to 2030 in a PDF by filling out the form below.
Key Therapeutic Areas Affected by 2026 Expiries
Cardiovascular & Thrombotic Agents
This is the single most consequential category for European healthcare budgets in 2026.
- Eliquis (apixaban): The cornerstone of stroke prevention and anticoagulation therapy in Europe. The core SPC is set to expire in May 2026, opening the door to generic competition in the second half of the year.
- Entresto / Neparvis (sacubitril/valsartan): The EMA’s 10-year market protection window closes in May 2026, creating a critical entry point for European generic challengers despite remaining secondary patent complexity.
Virology: HIV and Hepatitis C Transition
2026 marks a generational shift for antiviral therapies approved during the mid-2010s.
- HIV (Descovy & Odefsey): Both regimens reach their 10-year EMA exclusivity milestone in April and June 2026, respectively.
- Hepatitis C (Epclusa & Zepatier): Curative therapies lose regulatory exclusivity in July 2026, accelerating the final phase of HCV generic transition across Europe.
Oncology & Hematology
Rather than mass-market oncology drugs, 2026 is defined by targeted and orphan oncology therapies.
- Venclyxto (venetoclax): Orphan exclusivity for chronic lymphocytic leukemia (CLL) ends in December 2026.
- Kovaltry (octocog alfa): Hemophilia A treatment reaches the end of its 10-year protection in February 2026.
Metabolic Health & Diabetes
While next-generation GLP-1 therapies remain protected, 2026 marks the beginning of legal and strategic positioning for metabolic treatments.
- Semaglutide (Ozempic): Although SPC protection extends to 2031 in most EU markets, compound patent expiries in March 2026 signal the start of patent challenges and biosimilar readiness.
Rare Diseases (Orphan Medicines)
Orphan exclusivity is one of the most predictable regulatory timelines, making this category especially attractive for strategic planning.
- Galafold (migalastat) – Fabry disease: May 2026
- Wakix (pitolisant) – Narcolepsy: March 2026
- Strimvelis – Gene therapy: May 2026
EMA-Authorised Medicines Reaching Regulatory Exclusivity Milestones in 2026
| Brand Name | Active Substance | EMA Auth. Date | 2026 Expiry Month |
| Neparvis | Sacubitril / Valsartan | May 26, 2016 | May 2026 |
| Kovaltry | Octocog alfa | Feb 15, 2016 | February 2026 |
| Briviact | Brivaracetam | Jan 14, 2016 | January 2026 |
| Descovy | Emtricitabine / Tenofovir alafenamide | April 21, 2016 | April 2026 |
| Epclusa | Sofosbuvir / Velpatasvir | July 6, 2016 | July 2026 |
| Zepatier | Elbasvir / Grazoprevir | July 22, 2016 | July 2026 |
| Taltz | Ixekizumab | April 25, 2016 | April 2026 |
| Odefsey | Emtricitabine / Tenofovir alafenamide | June 21, 2016 | June 2026 |
Note: Actual generic entry may be delayed by SPCs, secondary patents, or national litigation.
Orphan-Designated Medicines Losing EMA Orphan Exclusivity in 2026
| Brand Name | Active Substance | Exclusivity Type | 2026 Expiry Month |
| Galafold | Migalastat | Orphan Exclusivity | May 2026 |
| Onivyde | Irinotecan (liposomal) | Orphan Exclusivity | October 2026 |
| Wakix | Pitolisant | Orphan Exclusivity | March 2026 |
| Strimvelis | Autologous CD34+ cells | Orphan Exclusivity | May 2026 |
| Zalmoxis | Allogeneic T cells | Orphan Exclusivity | August 2026 |
| Coagadex | Factor X | Orphan Exclusivity | January 2026 |
| Venclyxto | Venetoclax | Orphan Exclusivity | December 2026 |
| Idelvion | Albutrepenonacog alfa | Orphan Exclusivity | May 2028 (Extended)* |
Beyond the Dates: Why “Loss of Exclusivity” Is Not a Clean Break
A regulatory expiry does not automatically translate into market entry. Secondary patents, SPC extensions, pediatric add-ons, and country-specific litigation frequently delay competition by months or years.
For example, Ozempic (semaglutide) remains SPC-protected until 2031 in most EU markets, despite earlier compound patent dates. Similarly, drugs like Stelara and Pradaxa reached their effective cliffs earlier than many outdated projections suggested.
Understanding where regulatory exclusivity ends and patent protection begins is where real competitive advantage is created.
Tracking these drugs is only part of the story. To navigate effectively, pharma teams need visibility into the entire EMA approval and exclusivity landscape.
Strategic Takeaway
As we approach 2026, the companies that succeed won’t just be the ones with the lowest manufacturing costs. They will be the ones with the best regulatory foresight. Navigating the gap between a “Marketing Authorisation Date” and an “SPC Expiration” is where the real margin is found.
That’s why we’ve built the Elixir EMA Dashboard, a platform that maps the 8+2+1 regulatory framework against real-world patent and exclusivity data and 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.
