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Last Updated: March 29, 2024

Benztropine mesylate - Generic Drug Details


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What are the generic drug sources for benztropine mesylate and what is the scope of patent protection?

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. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for benztropine mesylate

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Drug Sales Revenue Trends for benztropine mesylate

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Recent Clinical Trials for benztropine mesylate

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

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Generic filers with tentative approvals for BENZTROPINE MESYLATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE;INJECTION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
Medical Subject Heading (MeSH) Categories for benztropine mesylate

US Patents and Regulatory Information for benztropine mesylate

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 081265-002 Jan 23, 1992 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pliva BENZTROPINE MESYLATE benztropine mesylate TABLET;ORAL 089060-001 Aug 10, 1988 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Invagen Pharms BENZTROPINE MESYLATE benztropine mesylate TABLET;ORAL 090294-001 Mar 29, 2010 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
>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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