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COGENTIN

NDA

BENZTROPINE MESYLATE | N009193 | MERCK AND CO 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-7927 Hyman, Phelps & McNamara, P.C. filed a suitability petition requesting that the FDA evaluate whether a particular drug product or manufacturing process is suitable for regulatory approval. The petition asks the FDA to provide guidance or a determination regarding regulatory pathways such as NDA or A	Suitability	2026-07-20	Open	Hyman, Phelps & McNamara, P.C.
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2018-P-2720 Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA amend the Orange Book to designate ANDA 204713 (or another appropriate ANDA) as an additional Reference Standard for Benztropine Mesylate Tablets in 0.5 mg, 1 mg, and 2 mg strengths, because the current reference stan	505(q)	2018-07-13	Open	Hyman, Phelps & McNamara, P.C.

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

Clinical Trials

7 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia NCT00802100	Phase 4	Completed	National Institute of Mental Health (NIMH)	21	2008-12 → 2009-10
Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)NCT00066937	Phase 2	Completed	Johns Hopkins University	140	2002-11 → 2008-07
Evaluation of Benztropine for Cocaine Craving - 2 NCT00000333	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	—	2001-05 → 2003-04
Effect of Antidepressants on Back Pain NCT00018200	Phase 2	Completed	US Department of Veterans Affairs	130	1999-04 → 2004-03
A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection NCT00000793	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	240	— → 1997-10
Efficacy of Antidepressants in Chronic Back Pain NCT00964886	Phase 2	Completed	VA Office of Research and Development	142	2010-01 → 2015-12
Anticholinergic Burden in Schizophrenia NCT00715377	N/A	Terminated	Centre for Addiction and Mental Health	2	2007-06 → 2011-12

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

API Supply Chain8 active DMFs1 inactive

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

FINE CHEMICALS CORP PTY LTDBENZTROPINE MESYLATE

DMF 69141987

DR REDDYS LABORATORIES LTDBENZTROPINE MESYLATE USP

DMF 70331987

ARCH PHARMALABS LTDBENZTROPINE MESYLATE USP

DMF 237192010

CURIA WISCONSIN INCBENZTROPINE MESYLATE

DMF 288402015

NAVINTA LLCBENZTROPINE MESYLATE USP

DMF 321362018

HARMAN FINOCHEM LTDBENZTROPINE MESYLATE USP

DMF 331262018

ESCIENTIA ADVANCED SCIENCES PRIVATE LTDBENZTROPINE MESYLATE USP

DMF 334802019

KALINTIS HEALTHCARE PVT LTDBENZTROPINE MESYLATE USP

DMF 349642020

ORION CORP LTDInactiveBENZTROPINE MESYLATE

DMF 61891986

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 16, 2003	ORIG -1	View Letter (PDF)
May 22, 2001	SUPPL -37	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#002 — 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#004 — 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982