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NIMBEX

NDA

CISATRACURIUM BESYLATE | N020551 | ABBVIE INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from On Demand Pharmaceuticals, Inc. FDA-2024-P-5184 On Demand Pharmaceuticals, Inc. submitted a suitability petition under 21 CFR 314.93 requesting FDA permission to file an ANDA under Section 505(j) for Cisatracurium Besylate for Injection in a 500 mg/250 ml Pharmacy Bulk Package bag, which differs from the reference listed drug Nimbex (NDA 020551,	Suitability	2024-11-05	Open	On Demand Pharmaceuticals
Suitability Petition from On Demand Pharmaceuticals, Inc. FDA-2024-P-5185 On Demand Pharmaceuticals, Inc. submitted this suitability petition under 21 CFR 314.93 requesting permission to file an ANDA under Section 505(j) for cisatracurium besylate for injection in a 500 mg/250 ml Pharmacy Bulk Package bag with a proposed 90-day shelf life, compared to the reference listed	Suitability	2024-11-05	Open	On Demand Pharmaceuticals

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain9 active DMFs2 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

GLAND PHARMA LTDCISATRACURIUM BESYLATE

DMF 229622009

TAPI NL BVCISATRACURIUM BESYLATE

DMF 231302009

WAVELENGTH ENTERPRISES LTDCISATRACURIUM BESYLATE

DMF 235542010

CF PHARMA LTDCISATRACURIUM BESYLATE VERSION FA1

DMF 249022012

CF PHARMA LTDCISATRACURIUM BESYLATE

DMF 249692012

FARMHISPANIA SACISATRACURIUM BESYLATE USP

DMF 249992011

GLAND PHARMA LTDCISATRACURIUM BESYLATE [PROCESS-II]

DMF 297382015

WAVELENGTH ENTERPRISES LTDCISATRACURIUM BESYLATE PROCESS B

DMF 391232024

NAVINTA LLCCISATRACURIUM BESYLATE USP

DMF 416042025

ALP PHARM BEIJING CO LTDInactiveCISATRACURIUM BESYLATE

DMF 240332010

ON DEMAND PHARMACEUTICALS INCInactiveCISATRACURIUM BESYLATE

DMF 405932025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Oct 17, 2022	SUPPL -28	View Letter (PDF)
Jul 30, 2018	SUPPL -20	View Letter (PDF)
Jul 30, 2018	SUPPL -26	View Letter (PDF)
Nov 30, 2010	SUPPL -19	View Letter (PDF)
Jun 8, 2010	SUPPL -17	View Letter (PDF)
Jul 28, 2003	SUPPL -9	View Letter (PDF)
Jun 4, 2002	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 15, 1995

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 15, 1995

#003 — EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 15, 1995