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Last Updated: March 29, 2024

Clemastine fumarate - Generic Drug Details


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What are the generic drug sources for clemastine fumarate and what is the scope of patent protection?

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
United States Department of DefensePhase 1/Phase 2
University of California, San FranciscoPhase 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
Novartis TAVIST clemastine fumarate TABLET;ORAL 017661-001 Approved Prior to Jan 1, 1982 DISCN Yes 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
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
Actavis Mid Atlantic CLEMASTINE FUMARATE clemastine fumarate SYRUP;ORAL 074075-001 Oct 31, 1993 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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