NIVOLUMAB | B125527 | BRISTOL MYERS SQUIBB
No 12-year reference-product exclusivity is listed in the Purple Book.
Marketing-entry ceiling (litigation risk)
No listed or discovered patents.
Disclaimer: Identifying an available carve-out is not a prediction that FDA will approve the particular carved label, nor that marketing it is free of infringement risk. For biologics, availability turns on exclusivities, not patents: FDA licenses a biosimilar (full or carved label) without adjudicating any patent, and patent disputes run through the § 262(l) patent dance and ordinary litigation, outside this availability view.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Bristol-Myers Squibb Co. et al v. AstraZeneca Pharmaceuticals LP et al 8 patentsnivolumab (Opdivo); durvalumab (Imfinzi) | D. Del. | 2022-03-17 | Terminated 2023-07-31 | — |
| D. Del. | 2015-07-07 | Terminated 2017-01-23 | — | |
Bristol-Myers Squibb Co. et al v. Merck & Co., Inc. et al 2 patentsnivolumab; pembrolizumab | D. Del. | 2015-06-30 | Terminated 2017-01-23 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.