BEXAROTENE Drug Patent Profile
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Which patents cover Bexarotene, and when can generic versions of Bexarotene launch?
Bexarotene is a drug marketed by Amneal Pharms Ny, Ani Pharms, Ascent Pharms Inc, Bionpharma, Hikma, Teva Pharms Usa, Upsher Smith Labs, and Amneal. and is included in eight NDAs.
The generic ingredient in BEXAROTENE is bexarotene. There are seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the bexarotene profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bexarotene
A generic version of BEXAROTENE was approved as bexarotene by BIONPHARMA on August 12th, 2014.
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Questions you can ask:
- What is the 5 year forecast for BEXAROTENE?
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- What is Average Wholesale Price for BEXAROTENE?
Summary for BEXAROTENE
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 130 |
| Clinical Trials: | 48 |
| Drug Prices: | Drug price information for BEXAROTENE |
| What excipients (inactive ingredients) are in BEXAROTENE? | BEXAROTENE excipients list |
| DailyMed Link: | BEXAROTENE at DailyMed |
Recent Clinical Trials for BEXAROTENE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Memorial Sloan Kettering Cancer Center | Phase 1 |
| Case Comprehensive Cancer Center | N/A |
| National Medical Research Council (NMRC), Singapore | Phase 1 |
Pharmacology for BEXAROTENE
| Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for BEXAROTENE
US Patents and Regulatory Information for BEXAROTENE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms Ny | BEXAROTENE | bexarotene | CAPSULE;ORAL | 210105-001 | Sep 4, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Upsher Smith Labs | BEXAROTENE | bexarotene | CAPSULE;ORAL | 209886-001 | Jul 25, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bionpharma | BEXAROTENE | bexarotene | CAPSULE;ORAL | 203174-001 | Aug 12, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal | BEXAROTENE | bexarotene | GEL;TOPICAL | 215398-001 | Apr 27, 2022 | AB | RX | 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 |
EU/EMA Drug Approvals for BEXAROTENE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Eisai GmbH | Targretin | bexarotene | EMEA/H/C/000326 Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment. |
Authorised | no | no | no | 2001-03-29 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
