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Last Updated: November 21, 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 Heightsrx, Teva Pharms, Wockhardt Bio Ag, Novartis, Ani Pharms, L Perrigo Co, Omnivium Pharms, Pld Acquisitions Llc, 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
US Patents:0
Tradenames:3
Applicants:13
NDAs:14
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 86
Clinical Trials: 10
Patent Applications: 6,112
What excipients (inactive ingredients) are in clemastine fumarate?clemastine fumarate excipients list
DailyMed Link:clemastine fumarate at DailyMed
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
L Perrigo Co CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 074512-001 Nov 22, 1995 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ani Pharms CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 073282-002 Dec 3, 1992 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Wockhardt Bio Ag CLEMASTINE FUMARATE clemastine fumarate SYRUP;ORAL 074863-001 Mar 13, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ani Pharms CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 073282-001 Jan 31, 1992 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex Inc CLEMASTINE FUMARATE clemastine fumarate SYRUP;ORAL 075703-001 Nov 27, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genus CLEMASTINE FUMARATE clemastine fumarate SYRUP;ORAL 073399-001 Jun 30, 1994 AA RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis TAVIST-1 clemastine fumarate TABLET;ORAL 017661-002 Approved Prior to Jan 1, 1982 DISCN 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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