Clemastine fumarate - Generic Drug Details
✉ Email this page to a colleague
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 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
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 13 |
NDAs: | 14 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 86 |
Clinical Trials: | 9 |
Patent Applications: | 6,533 |
Formulation / Manufacturing: | see details |
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 |
---|---|
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Wockhardt Bio Ag | CLEMASTINE FUMARATE | clemastine fumarate | SYRUP;ORAL | 074863-001 | Mar 13, 1998 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | TAVIST-1 | clemastine fumarate | TABLET;ORAL | 017661-002 | Approved Prior to Jan 1, 1982 | 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 | ||||
Novartis | TAVIST | clemastine fumarate | SYRUP;ORAL | 018675-001 | Jun 28, 1985 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
New Heights | CLEMASTINE FUMARATE | clemastine fumarate | SYRUP;ORAL | 074884-001 | Dec 17, 1997 | 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 |