ZANUBRUTINIB | N218785 | BEONE MEDICINES USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2026-P-7337 Zydus Pharmaceuticals (USA) Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA determination that Zanubrutinib Tablets in 80 mg and 320 mg strengths are suitable for submission as an Abbreviated New Drug Application, with BRUKINS | Suitability | 2026-07-02 | Open | Zydus Pharmaceuticals (USA) Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9447106 | Apr 22, 2034 | — | Yes | Yes | — | |
| 10570139 | Apr 22, 2034 | — | — | — | — | |
| 10927117 | Aug 15, 2037 | — | Yes | Yes | — | — |
| 11142528 | Apr 22, 2034 | — | — | Yes | — | |
| 11591340 | Aug 15, 2037 | — | — | — | — | |
| 11701357 | Jun 24, 2039 | — | — | — | — | |
| 11786531 | Jan 19, 2043 | — | — | — | — | |
| 11851437 | Aug 15, 2037 | — | Yes | Yes | — | — |
| 11884674 | Aug 15, 2037 | — | — | — | — | |
| 11896596 | Jan 19, 2043 | — | — | — | — | |
| 11911386 | Jan 19, 2043 | — | — | — | — | |
| 11970500 | Aug 15, 2037 | — | — | — | — | |
| 12233069 | Jun 10, 2040 | — | — | Yes | — | — |
| Code | Date | Status |
|---|---|---|
| I-817 | Jan 19, 2026 | Expired |
| I-936 | Mar 7, 2027 | < 1 year |
| ODE* | Mar 7, 2031 | Active |