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
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | TAVIST | clemastine fumarate | TABLET;ORAL | 017661-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ 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 | ||||
| Ani Pharms | CLEMASTINE FUMARATE | clemastine fumarate | TABLET;ORAL | 073282-002 | Dec 3, 1992 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Omnivium Pharms | CLEMASTINE FUMARATE | clemastine fumarate | TABLET;ORAL | 073459-001 | Oct 31, 1993 | DISCN | 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 | 073282-001 | Jan 31, 1992 | 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 |
