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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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from On Demand Pharmaceuticals, Inc. FDA-2024-P-5184 · 7 docket documents 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	Granted	On Demand Pharmaceuticals, Inc.
Suitability Petition from On Demand Pharmaceuticals, Inc. FDA-2024-P-5185 · 7 docket documents 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	Denied	On Demand Pharmaceuticals, Inc.

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

Clinical Trials

30 trials from ClinicalTrials.gov, 17 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Endotracheal Intubation Without Muscle Relaxants NCT03112564	N/A	Completed	Puerta de Hierro University Hospital	91	2013-03-01 → 2014-12-15
Etomidate to Improve Outcome in Elderly Patients NCT02910206	N/A	Completed	Zhihong LU	1,917	2017-08-15 → 2020-11-20
The Study of Pharmacokinetics and Pharmacodynamics of Cisatracurium NCT03337373	Phase 4	Completed	Mahidol University	10	2017-12-15 → 2018-08-31
Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia NCT02481193	Phase 3	Completed	Yangzhou No.1 People's Hospital	90	2013-03 → 2014-01
Comparison Between Cisatracurium and Rocuronium in Terms of Recovery of the Muscular Strength in the Postoperative Phase After Surgery and General Anaesthesia NCT01651572	Phase 4	Completed	Azienda Ospedaliera di Padova	120	2012-07 → 2013-07
Effects of Intravenous Lidocaine Associated With Magnesium Sulfate on the Cisatracurium-Induced Neuromuscular Block NCT02483611	Phase 4	Completed	University of Sao Paulo	48	2015-07 → 2015-09
Neuromuscular Blockade in Patients With Severe Renal Impairment NCT03904550	Phase 2	Completed	University of Texas Southwestern Medical Center	49	2019-12-10 → 2023-07-01
Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery NCT01690364	N/A	Completed	Samsung Medical Center	74	2012-07 → 2013-03
Effect of Cisatracurium Versus Atracurium on Intraocular Pressure in Patients Underwent General Anesthesia NCT01273831	Phase 2	Completed	Isfahan University of Medical Sciences	90	2009-07 → 2009-12
Effects of Cisatracurium on Sccinylcholine-induced Fasciculations NCT02502032	Phase 3	Completed	Zhuan Zhang	87	2015-07 → 2015-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain9 active DMFs3 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

JIANGSU HENGRUI PHARMACEUTICALS CO LTDInactiveCISATRACURIUM BESYLATE, USP, NON-STERILE, BULK DRUG SUBSTANCE

DMF 255112011

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