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 · 7 docket documents 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, Phelps & McNamara, P.C. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2023-P-4325 · 8 docket documents 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 | Granted | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from HBT Labs, Inc. FDA-2022-P-2075 · 4 docket documents 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 | 505(q) | 2022-08-31 | Partially Denied | HBT Labs, Inc. |
Citizen Petition from Hyman, Phelps, & McNamara PC FDA-2020-P-0512 · 7 docket documents Hyman, Phelps and McNamara, P.C. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine Paclitaxel protein-bound particles for Injectable Suspension (albumin bound) in 50 mg/vial and 300 mg/vial lyophilized powder formula | Other | 2020-01-31 | Withdrawn | Hyman, Phelps, & McNamara PC |
Citizen Petition from Lachman Consultants FDA-2019-P-1318 · 6 docket documents Lachman Consultants filed this citizen petition on March 19, 2019, requesting that the FDA determine Paclitaxel for Injectable Suspension in a 200 mg/vial lyophilized powder formulation is suitable for submission in an ANDA, with Abraxane (paclitaxel protein-bound particle) approved under NDA 021660 | Other | 2019-03-20 | Withdrawn | Lachman Consultants |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2016-P-1364 · 5 docket documents Lachman Consultant Services, Inc., on behalf of a client, filed this ANDA suitability petition under Section 505(j)(2)(C) of the FD&C Act to request FDA approval for submission of an ANDA for Paclitaxel for Injectable Suspension in a 250 mg/vial lyophilized powder, a change in strength from the list | Other | 2016-05-27 | Open | Lachman Consultant Services, Inc. |
Citizen Petition from Arnold & Porter LLP (Celgene) FDA-2015-P-0732 · 97 docket documents Celgene Corporation and Abraxis BioScience LLC, represented by Arnold & Porter LLP, submitted this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that FDA establish stringent standards for approval of abbreviated new drug applications relying on ABRAXANE (p | 505(q) | 2015-03-10 | Partially Denied | Arnold & Porter LLP (Celgene) |
Citizen Petition from Mediscovery, Inc. FDA-2006-P-0342 · 3 docket documents Mediscovery, Inc. filed this citizen petition under Section 505(j)(2)(C) of the FDC Act requesting permission to submit an abbreviated new drug application for Paclitaxel at a strength of 0.1 pM for aerosol administration, differing from the reference listed drug Taxol in both strength and route of | Other | 2008-12-12 | Open | Mediscovery, Inc. |
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 | — | — | — |