CLEMASTINE FUMARATE Drug Patent Profile
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Which patents cover Clemastine Fumarate, and when can generic versions of Clemastine Fumarate launch?
Clemastine Fumarate is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Genus, New Heightsrx, Teva Pharms, Wockhardt Bio Ag, Ani Pharms, L Perrigo Co, Omnivium Pharms, Pld Acquisitions Llc, and Teva. and is included in eleven NDAs.
The generic ingredient in CLEMASTINE FUMARATE is clemastine fumarate. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Clemastine Fumarate
A generic version of CLEMASTINE FUMARATE was approved as clemastine fumarate by TEVA on January 31st, 1992.
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Questions you can ask:
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Summary for CLEMASTINE FUMARATE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 86 |
| Clinical Trials: | 10 |
| Patent Applications: | 3,376 |
| DailyMed Link: | CLEMASTINE FUMARATE at DailyMed |
Recent Clinical Trials for CLEMASTINE FUMARATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| United States Department of Defense | Phase 1/Phase 2 |
| University of California, San Francisco | Phase 1/Phase 2 |
| Amsterdam UMC, location VUmc | Phase 3 |
Medical Subject Heading (MeSH) Categories for CLEMASTINE FUMARATE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Mid Atlantic | CLEMASTINE FUMARATE | clemastine fumarate | SYRUP;ORAL | 074075-001 | Oct 31, 1993 | 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 | ||||
| New Heightsrx | CLEMASTINE FUMARATE | clemastine fumarate | SYRUP;ORAL | 074884-001 | Dec 17, 1997 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva | CLEMASTINE FUMARATE | clemastine fumarate | TABLET;ORAL | 073283-001 | Jan 31, 1992 | RX | No | Yes | ⤷ 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 | ||||
| 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
