PACLITAXEL | N021660 | BRISTOL-MYERS SQUIBB CO
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ABRAXIS BIOSCIENCE, LLC v. DR. REDDY'S LABORATORIES, INC. et al 4 patentsANDA 214724paclitaxel protein-bound particles for injectable suspension | D.N.J. | 2026-04-02 | Active | — |
ABRAXIS BIOSCIENCE, LLC v. QILU PHARMACEUTICAL (HAINAN) CO., LTD. 7 patentsANDA 220144paclitaxel protein-bound particles for injectable suspension | D.N.J. | 2026-01-08 | Active | — |
ABRAXIS BIOSCIENCE, LLC v. SUN PHARMA ADVANCED RESEARCH COMPANY, LTD. et al 12 patentspaclitaxel protein-bound particles for injectable suspension | D.N.J. | 2019-08-08 | Terminated 2019-12-11 | — |
ABRAXIS BIOSCIENCE, LLC et al v. HBT LABS, INC. 12 patentspaclitaxel protein-bound particles for injectable suspension | D.N.J. | 2018-12-17 | Terminated 2019-02-07 | — |
ABRAXIS BIOSCIENCE, LLC et al v. CIPLA LTD. 4 patentsANDA 209657paclitaxel protein-bound particles for injectable suspension | D.N.J. | 2016-12-07 | Terminated 2018-10-09 | — |
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-1476 Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Paclitaxel protein-bound particles for Injectable Suspension in a 200 mg/vial lyophilized powder | Suitability | 2025-05-30 | Open | Hyman |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2023-P-4325 The law firm Hyman, Phelps & McNamara, P.C. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Paclitaxel protein-bound particles for Injectable Suspension in 50 mg/vial and 300 mg/vial lyophilized powder form | Suitability | 2023-10-03 | Open | Hyman |
Citizen Petition from HBT Labs, Inc. FDA-2022-P-2075 HBT Labs, Inc. submitted this petition on August 30, 2022, requesting that the FDA assign a therapeutic equivalence evaluation code of "AP" in the Orange Book to its Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), 100 mg/vial, approved under NDA 211875, to establish the | Other | 2022-08-31 | Denied | HBT Labs |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7758891 | Feb 21, 2026PED: Aug 21, 2026 | PED | — | — | — | |
| 8034375 | Aug 13, 2026PED: Feb 13, 2027 | PED | — | — | — | |
| 8268348 | Feb 21, 2026PED: Aug 21, 2026 | PED | — | — | — | |
| 9101543 | Feb 21, 2026PED: Aug 21, 2026 | PED | — | — | — | |
| 9393318 | Mar 4, 2032PED: Sep 4, 2032 | PED | — | — | — | |
| 9511046 | Jan 12, 2034PED: Jul 12, 2034 | PED | — | — | — | |
| 9597409 | Mar 4, 2032PED: Sep 4, 2032 | PED | — | — | — |