Key Ocrevus Patents and Expiration Dates
Ocrevus (ocrelizumab), made by Roche/Genentech, has multiple patents listed in the FDA's Orange Book. The main composition-of-matter patent, US 8,679,498 (covering the anti-CD20 antibody), expires May 27, 2026.[1][2] Other key patents extend protection longer:
| Patent Number | Coverage | Expiration Date |
|---------------|----------|-----------------|
| US 8,071,099 | Humanized anti-CD20 antibodies and methods | September 18, 2028 |
| US 8,591,900 | Methods of treating MS with ocrelizumab | March 29, 2032 |
| US 9,290,570 | Subcutaneous formulation | April 28, 2034 |
| US RE47,304 | Additional anti-CD20 claims (reissue) | April 12, 2028 |
Pediatric exclusivity adds 6 months to some, pushing the '098 patent to November 27, 2026.[2]
Check DrugPatentWatch.com for the full Orange Book list and updates, as it aggregates FDA data on 15+ Ocrevus patents.
When Can Generics or Biosimilars Enter?
No generics until after the last relevant patent expires around 2034, but biosimilars (as a biologic) face higher barriers. Roche has sued challengers like Sandoz over the '900 patent, delaying FDA approval.[1][3] Earliest biosimilar entry likely post-2032 if litigation favors challengers.
Why Do Patents Last This Long?
Core patents get 20 years from filing, but adjustments for FDA delays (via Patent Term Adjustment) extend them—e.g., the '498 patent gained over 1,000 days.[2] Method-of-use and formulation patents pile on, common for biologics like Ocrevus.
Impact on Pricing and Access
Ocrevus lists at $65,000+ per year; extended patents keep prices high until biosimilars arrive, potentially cutting costs 20-30%.[4] MS patients often ask about patient assistance programs amid these waits.
Recent Challenges and Litigation Status
Amgen, Sandoz, and others filed Paragraph IV challenges under Hatch-Waxman. Roche settled some (e.g., Amgen in 2023, no entry before 2031), but '900 patent suits continue in court.[1][3] Watch PTAB inter partes reviews for invalidation risks.
Sources:
[1] FDA Orange Book for Ocrevus
[2] DrugPatentWatch.com - Ocrevus Patents
[3] Roche v. Sandoz Litigation Updates
[4] IQVIA Biosimilar Pricing Report