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

See drug prices for bexarotene

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 Cancer Centre, Singapore	Phase 1

See all bexarotene clinical trials

Pharmacology for bexarotene

Drug Class	Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for bexarotene

L01XF	Retinoids for cancer treatment
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for bexarotene

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Glossary

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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
Valeant Luxembourg	TARGRETIN	bexarotene	CAPSULE;ORAL	021055-001	Dec 29, 1999	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	BEXAROTENE	bexarotene	CAPSULE;ORAL	203663-001	Jun 16, 2020	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

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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

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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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