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

Sponsor

Phase

National Institute of Allergy and Infectious Diseases (NIAID)

Phase 2

Boehringer Ingelheim

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
Oxford Pharms	BENZTROPINE MESYLATE	benztropine mesylate	TABLET;ORAL	040706-001	Feb 14, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	BENZTROPINE MESYLATE	benztropine mesylate	TABLET;ORAL	040715-001	Aug 27, 2007	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lannett Co Inc	BENZTROPINE MESYLATE	benztropine mesylate	TABLET;ORAL	088894-001	Apr 11, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Usl Pharma	BENZTROPINE MESYLATE	benztropine mesylate	TABLET;ORAL	089211-001	Jun 14, 1988		DISCN	No	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