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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Benztropine Mesylate* (2023)

Total Spending

$27.2M

Total Claims

1,991,946

Beneficiaries

256,301

Avg Cost/Unit

$0.25

Spending Trend

$26.6M(2019)→$28.2M(2020)→$28.6M(2021)→$27.8M(2022)→$27.2M(2023)

YoY Change:+1.8%

5yr CAGR:+2.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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#002 — 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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#003 — 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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