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Last Updated: March 19, 2024

Clemastine fumarate - Generic Drug Details


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What are the generic sources for clemastine fumarate and what is the scope of freedom to operate?

Clemastine fumarate is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Apotex Inc, Genus, New Heights, Teva Pharms, Wockhardt Bio Ag, Novartis, Ani Pharms, L Perrigo Co, Pld Acquisitions Llc, Sandoz, Teva, and Haleon Us Holdings, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for clemastine fumarate
Recent Clinical Trials for clemastine fumarate

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

SponsorPhase
University of California, San FranciscoPhase 1/Phase 2
United States Department of DefensePhase 1/Phase 2
Amsterdam UMC, location VUmcPhase 3

See all clemastine fumarate clinical trials

Medical Subject Heading (MeSH) Categories for clemastine fumarate

US Patents and Regulatory Information for clemastine fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
L Perrigo Co CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 074512-001 Nov 22, 1995 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 073282-002 Dec 3, 1992 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 073282-001 Jan 31, 1992 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pld Acquisitions Llc CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 073458-001 Oct 31, 1993 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc CLEMASTINE FUMARATE clemastine fumarate SYRUP;ORAL 075703-001 Nov 27, 2000 DISCN 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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