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Last Updated: November 22, 2024

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
Drug Prices for BEXAROTENE

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Recent Clinical Trials for BEXAROTENE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Memorial Sloan Kettering Cancer CenterPhase 1
Case Comprehensive Cancer CenterN/A
National Medical Research Council (NMRC), SingaporePhase 1

See all BEXAROTENE clinical trials

Pharmacology for BEXAROTENE
Drug ClassRetinoid

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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