BENZTROPINE MESYLATE - Generic Drug Details

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What are the generic sources for benztropine mesylate and what is the scope of freedom to operate?

Benztropine mesylate is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Luitpold, Navinta Llc, Epic Pharma Llc, Aiping Pharm Inc, Chartwell Rx, Endo Operations, Invagen Pharms, Lannett Co Inc, Leading, Nuvo Pharm, Oxford Pharms, Pliva, Quantum Pharmics, Usl Pharma, and Merck, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for benztropine mesylate. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Sponsor	Phase
Boehringer Ingelheim	Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2

Sponsor

Phase

Boehringer Ingelheim

Phase 2

National Institute of Allergy and Infectious Diseases (NIAID)

Phase 2

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	BENZTROPINE MESYLATE	benztropine mesylate	TABLET;ORAL	081265-003	Nov 29, 2023	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Merck	COGENTIN	benztropine mesylate	TABLET;ORAL	009193-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Usl Pharma	BENZTROPINE MESYLATE	benztropine mesylate	TABLET;ORAL	089213-001	Jun 14, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aiping Pharm Inc	BENZTROPINE MESYLATE	benztropine mesylate	TABLET;ORAL	040103-003	Dec 12, 1996	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Merck	COGENTIN	benztropine mesylate	TABLET;ORAL	009193-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	2
Applicants:	18
NDAs:	29
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	1
Patent Applications:	1,990
Drug Prices:	Drug price trends for BENZTROPINE MESYLATE
Drug Sales Revenues:	Drug sales revenues for BENZTROPINE MESYLATE
What excipients (inactive ingredients) are in BENZTROPINE MESYLATE?	BENZTROPINE MESYLATE excipients list
DailyMed Link:	BENZTROPINE MESYLATE at DailyMed

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION

Drug Class	Anticholinergic Antihistamine
Mechanism of Action	Cholinergic Antagonists Histamine Receptor Antagonists