Core Yervoy Patent Expiration Dates
Yervoy (ipilimumab), Bristol Myers Squibb's CTLA-4 inhibitor for melanoma and other cancers, has multiple patents covering its composition, methods of use, and formulations. The primary composition of matter patent (US 7,109,003) expires October 25, 2027.[1] Key method-of-use patents extend protection longer, with some lasting until 2038, including US 8,691,184 (expires May 2033) and others tied to combination therapies.[1][2]
When Do Key Patents Actually Expire?
Patent terms are 20 years from filing, but adjustments for regulatory delays add up to five years via Patent Term Extension (PTE). Yervoy's main patents received PTE due to FDA approval in 2011:
- US 7,109,003 (anti-CTLA4 antibody): October 2027.[1]
- US 8,217,140 (dosing regimens): December 2028.[1]
- Later patents for combos with nivolumab (Opdivo) reach 2035-2038.[2]
Exclusivity layers include orphan drug status (expired 2018 for melanoma) and pediatric extensions, but these don't block generics broadly.[3]
Can Generics or Biosimilars Launch Before 2027?
No, due to "patent thickets." Bristol lists 20+ Orange Book patents, with at least 10 litigated challenges from Teva, Sandoz, and others dismissed or settled.[1][2] Biosimilars face higher hurdles as a biologic; Formycon and others target 2027+ entry, pending FDA interchangeability approval.[3] ANDA Paragraph IV challenges could shorten this if courts invalidate patents.
Why the Extended Protection Beyond Composition Patent?
Combination patents with PD-1 inhibitors like Opdivo create "evergreening," blocking rivals until 2035+.[2] Litigation history shows BMS defending combos aggressively; a 2022 settlement with Dr. Reddy's delays entry to 2030.[3]
What Happens After Patent Cliffs?
Post-2027, biosimilar competition ramps up, potentially cutting U.S. sales (peaked at $2B+ annually) by 50-70%, similar to Humira.[3] EU patents expired 2022, with Alvotech's biosimilar approved there.[2] Track updates on DrugPatentWatch for litigation.
[1]: DrugPatentWatch.com - Yervoy Patents
[2]: FDA Orange Book - Ipilimumab
[3]: USPTO Patent Term Calculator & Litigation Tracker