BEXAROTENE - Generic Drug Details
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What are the generic drug sources for bexarotene and what is the scope of freedom to operate?
Bexarotene
is the generic ingredient in two branded drugs marketed by Amneal Pharms Ny, Ani Pharms, Ascent Pharms Inc, Bionpharma, Hikma, Teva Pharms Usa, Upsher Smith Labs, Valeant Luxembourg, Amneal, and Bausch, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for bexarotene. Ten suppliers are listed for this compound.
Summary for BEXAROTENE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 10 |
NDAs: | 10 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 130 |
Clinical Trials: | 48 |
Drug Prices: | Drug price trends 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | |||
Teva Pharms Usa | BEXAROTENE | bexarotene | CAPSULE;ORAL | 209931-001 | Jan 14, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ani Pharms | BEXAROTENE | bexarotene | CAPSULE;ORAL | 209861-001 | May 8, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bausch | TARGRETIN | bexarotene | GEL;TOPICAL | 021056-001 | Jun 28, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ascent Pharms Inc | BEXAROTENE | bexarotene | CAPSULE;ORAL | 208628-001 | Sep 6, 2024 | 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 |
Expired US Patents for BEXAROTENE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch | TARGRETIN | bexarotene | GEL;TOPICAL | 021056-001 | Jun 28, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Valeant Luxembourg | TARGRETIN | bexarotene | CAPSULE;ORAL | 021055-001 | Dec 29, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Valeant Luxembourg | TARGRETIN | bexarotene | CAPSULE;ORAL | 021055-001 | Dec 29, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Valeant Luxembourg | TARGRETIN | bexarotene | CAPSULE;ORAL | 021055-001 | Dec 29, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | TARGRETIN | bexarotene | GEL;TOPICAL | 021056-001 | Jun 28, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | TARGRETIN | bexarotene | GEL;TOPICAL | 021056-001 | Jun 28, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
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