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 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

Sponsor	Phase
University of California, San Francisco	Phase 1/Phase 2
United States Department of Defense	Phase 1/Phase 2
Amsterdam UMC, location VUmc	Phase 3

See all CLEMASTINE FUMARATE clinical trials

Medical Subject Heading (MeSH) Categories for CLEMASTINE FUMARATE

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for CLEMASTINE FUMARATE

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

R06AA	Aminoalkyl ethers
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for CLEMASTINE FUMARATE

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Glossary

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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
>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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