OLAPARIB | N208558 | ASTRAZENECA PHARMACEUTICALS LP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ASTRAZENECA PHARMACEUTICALS LP et al v. NATCO PHARMA LIMITED 11 patentsANDA 218044olaparib | D.N.J. | 2025-01-09 | Terminated 2025-06-06 | — |
ASTRAZENECA PHARMACEUTICALS LP et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 10 patentsANDA 219893olaparib | D.N.J. | 2025-01-09 | Terminated 2025-06-06 | — |
ASTRAZENECA PHARMACEUTICALS LP et al v. CIPLA LIMITED et al 11 patentsANDA 219410olaparib | D.N.J. | 2025-01-09 | Terminated 2025-06-06 | — |
| D.N.J. | 2025-01-09 | Terminated 2025-06-06 | — | |
ASTRAZENECA PHARMACEUTICALS LP et al v. CIPLA LIMITED et al 7 patentsANDA 219410olaparib | D.N.J. | 2024-11-20 | Active | — |
ASTRAZENECA PHARMACEUTICALS LP et al v. CIPLA LIMITED et al 9 patentsANDA 219410olaparib | D.N.J. | 2024-07-31 | Active | — |
ASTRAZENECA PHARMACEUTICALS LP et al v. CIPLA LIMITED et al 5 patentsANDA 219410olaparib | D.N.J. | 2024-06-28 | Active | — |
| D.N.J. | 2024-02-02 | Active | — | |
| D.N.J. | 2023-02-10 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-0031 The law firm Hyman, Phelps & McNamara, P.C., filed this Suitability Petition on behalf of a client requesting that the FDA declare Olaparib Tablets, 250 mg, suitable for submission as an Abbreviated New Drug Application under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act. The petit | Suitability | 2025-01-07 | Open | Hyman |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-2885 The law firm Hyman, Phelps & McNamara, P.C., on behalf of a client, filed a Suitability Petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Olaparib Tablets in 200 mg and 300 mg strengths suitable for submission as an ANDA, with the refere | Suitability | 2024-06-17 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7449464 | Sep 8, 2027 | — | Yes | Yes | — | — |
| 8071579 | Aug 12, 2027 | — | — | — | — | |
| 8143241 | Aug 12, 2027 | — | — | — | — | |
| 8475842 | Dec 31, 2029 | — | — | Yes | — | — |
| 8859562 | Aug 4, 2031 | — | — | — | — | |
| 11633396 | Oct 7, 2029 | — | — | Yes | — | — |
| 11970530 | Oct 25, 2041 | — | — | — | — | |
| 11975001 | Oct 7, 2029 | — | — | Yes | — | — |
| 12048695 | Oct 7, 2029 | — | — | Yes | — | — |
| 12144810 | Oct 7, 2029 | — | — | Yes | — | — |
| 12178816 | Oct 7, 2029 | — | — | Yes | — | — |
| Code | Date | Status |
|---|---|---|
| I-914 | May 31, 2026 | Expired |
| ODE-283 | Dec 27, 2026 | < 1 year |
| ODE-306 | May 8, 2027 | < 1 year |