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Last Updated: November 30, 2023

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, Aspen Global Inc, Chartwell Rx, Invagen Pharms, Lannett Co Inc, Leading, Oxford Pharms, Pliva, Quantum Pharmics, Usl Pharma, Vintage, 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.

Summary for benztropine mesylate

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:	2,001
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for benztropine mesylate
What excipients (inactive ingredients) are in benztropine mesylate?	benztropine mesylate excipients list
DailyMed Link:	benztropine mesylate at DailyMed

See drug prices for benztropine mesylate

Drug Sales Revenue Trends for benztropine mesylate

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Recent Clinical Trials for benztropine mesylate

Identify potential brand extensions & 505(b)(2) entrants

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

See all benztropine mesylate clinical trials

Generic filers with tentative approvals for BENZTROPINE MESYLATE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	1MG/ML	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for benztropine mesylate

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

Medical Subject Heading (MeSH) Categories for benztropine mesylate

Antiparkinson Agents
Dopamine Uptake Inhibitors
Muscarinic Antagonists
Parasympatholytics

US Patents and Regulatory Information for benztropine mesylate

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Glossary

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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	081265-001	Jan 23, 1992	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Leading	BENZTROPINE MESYLATE	benztropine mesylate	TABLET;ORAL	090168-003	Nov 28, 2012	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Epic Pharma Llc	BENZTROPINE MESYLATE	benztropine mesylate	TABLET;ORAL	072265-001	Feb 27, 1989	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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