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Last Updated: July 20, 2024

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, Endo Operations, Invagen Pharms, Lannett Co Inc, Leading, 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. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

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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
⤷  Sign Up⤷  Sign Up1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE;INJECTION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
Pliva BENZTROPINE MESYLATE benztropine mesylate TABLET;ORAL 089058-001 Aug 10, 1988 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma BENZTROPINE MESYLATE benztropine mesylate INJECTABLE;INJECTION 209442-001 Oct 14, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations BENZTROPINE MESYLATE benztropine mesylate TABLET;ORAL 040715-003 Aug 27, 2007 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pliva BENZTROPINE MESYLATE benztropine mesylate TABLET;ORAL 089059-001 Aug 10, 1988 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aspen Global Inc BENZTROPINE MESYLATE benztropine mesylate TABLET;ORAL 204713-003 Apr 14, 2015 AA RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Leading BENZTROPINE MESYLATE benztropine mesylate TABLET;ORAL 090168-001 Nov 28, 2012 AA RX 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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.