When does Opdivo's main patent expire?
Opdivo's core composition-of-matter patent, US Patent 8,008,449 (covering nivolumab), expires on July 28, 2028, after pediatric exclusivity extension.[1][2]
Which patents protect Opdivo and their status?
Bristol Myers Squibb holds multiple patents listed in the FDA's Orange Book for Opdivo (nivolumab injection). Key ones include:
- US 8,008,449 (anti-PD-1 antibody composition): Expires July 28, 2028.
- US 8,779,108 (methods of use): Expires December 24, 2027.
- US 9,387,247 (crystalline forms): Expires April 21, 2032.
Over 20 patents total, with the latest expiring in 2036, creating layered protection beyond 2028.[1][3]
Can generics or biosimilars launch before 2028?
No full generics due to Opdivo's biologic status—only biosimilars possible, which face high barriers. Patent challenges via FDA's 351(k) pathway are ongoing; Amgen's ABP 798 was approved in 2024 but launch is blocked until at least 2028 by settlements or litigation.[2][4]
Why are there so many Opdivo patents?
Bristol Myers uses a "patent thicket" strategy: early patents on the molecule, later ones on formulations, manufacturing, and specific cancer uses (e.g., melanoma, lung cancer). This delays competition even after core expiry.[1][3]
When did Opdivo get FDA approval and key exclusivities?
Approved December 2014 for melanoma. No orphan drug exclusivity remains; 12-year biologic exclusivity ended 2026. Pediatric extensions add ~6 months to select patents.[2]
Who's challenging Opdivo's patents?
Samsung Bioepis, Amgen, and Formycon filed biosimilar applications with Paragraph IV challenges. Bristol Myers settled some, delaying launches to 2028-2031; others head to court.[3][4]
How does this affect pricing and access?
Opdivo lists at ~$13,000 per dose; post-2028 biosimilar entry could cut prices 20-40%, based on other oncology biologars. Patients on assistance programs face less immediate impact.[1][2]
[1]: DrugPatentWatch.com - Opdivo Patents
[2]: FDA Orange Book - Opdivo
[3]: USPTO Patent Database
[4]: FDA Biosimilar Approvals