TETRABENAZINE Drug Patent Profile
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Which patents cover Tetrabenazine, and when can generic versions of Tetrabenazine launch?
Tetrabenazine is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Apotex, Bionpharma, Chartwell Rx, Dr Reddys, Hetero Labs Ltd V, Hikma, Mylan, Slate Run Pharma, and Sun Pharm. and is included in eleven NDAs.
The generic ingredient in TETRABENAZINE is tetrabenazine. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the tetrabenazine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tetrabenazine
A generic version of TETRABENAZINE was approved as tetrabenazine by HETERO LABS LTD V on February 3rd, 2016.
Summary for TETRABENAZINE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 134 |
| Clinical Trials: | 13 |
| Patent Applications: | 2,298 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TETRABENAZINE |
| What excipients (inactive ingredients) are in TETRABENAZINE? | TETRABENAZINE excipients list |
| DailyMed Link: | TETRABENAZINE at DailyMed |
Recent Clinical Trials for TETRABENAZINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| H. Lundbeck A/S | Phase 4 |
| William Ondo, MD | Phase 4 |
| The University of Texas Health Science Center, Houston | Phase 4 |
Pharmacology for TETRABENAZINE
| Drug Class | Vesicular Monoamine Transporter 2 Inhibitor |
| Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
Medical Subject Heading (MeSH) Categories for TETRABENAZINE
Anatomical Therapeutic Chemical (ATC) Classes for TETRABENAZINE
US Patents and Regulatory Information for TETRABENAZINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Labs Fl Inc | TETRABENAZINE | tetrabenazine | TABLET;ORAL | 206686-001 | Jul 7, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Slate Run Pharma | TETRABENAZINE | tetrabenazine | TABLET;ORAL | 213316-001 | Jan 22, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Bionpharma | TETRABENAZINE | tetrabenazine | TABLET;ORAL | 208826-002 | Dec 18, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Apotex | TETRABENAZINE | tetrabenazine | TABLET;ORAL | 206093-001 | Mar 17, 2020 | AB | RX | 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 |
