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Bexarotene - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for bexarotene?

Bexarotene is the generic ingredient in two branded drugs marketed by Valeant Luxembourg and Bionpharma Inc, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-two patent family members in seventeen countries.

There are five drug master file entries for bexarotene. Five suppliers are listed for this compound.

Summary for Generic Name: bexarotene

Tradenames:2
Patents:2
Applicants:2
NDAs:3
Drug Master File Entries: see list5
Suppliers / Packagers: see list5
Bulk Api Vendors: see list69
Clinical Trials: see list12
Patent Applications: see list4,724
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:bexarotene at DailyMed

Pharmacology for Ingredient: bexarotene

Ingredient-typeRetinoids
Drug ClassRetinoid
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Luxembourg
TARGRETIN
bexarotene
GEL;TOPICAL021056-001Jun 28, 2000RXYesYes5,962,731► Subscribe ► Subscribe
Valeant Luxembourg
TARGRETIN
bexarotene
CAPSULE;ORAL021055-001Dec 29, 1999RXYesYes► Subscribe► Subscribe
Bionpharma Inc
BEXAROTENE
bexarotene
CAPSULE;ORAL203174-001Aug 12, 2014RXNoNo► Subscribe► Subscribe
Valeant Luxembourg
TARGRETIN
bexarotene
CAPSULE;ORAL021055-001Dec 29, 1999RXYesYes5,962,731► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: bexarotene

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Luxembourg
TARGRETIN
bexarotene
CAPSULE;ORAL021055-001Dec 29, 19995,466,861► Subscribe
Valeant Luxembourg
TARGRETIN
bexarotene
GEL;TOPICAL021056-001Jun 28, 20006,043,279► Subscribe
Valeant Luxembourg
TARGRETIN
bexarotene
CAPSULE;ORAL021055-001Dec 29, 19995,962,731► Subscribe
Valeant Luxembourg
TARGRETIN
bexarotene
GEL;TOPICAL021056-001Jun 28, 20006,320,074► Subscribe
Valeant Luxembourg
TARGRETIN
bexarotene
GEL;TOPICAL021056-001Jun 28, 20005,962,731► Subscribe
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Non-Orange Book Patents for Generic Ingredient: bexarotene

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,655,699Compounds having selective activity for retinoid X receptors, and means for modulation of processes mediated by retinoid X receptors► Subscribe
5,780,676 Compounds having selective activity for Retinoid X Receptors, and means for modulation of processes mediated by Retinoid X Receptors► Subscribe
6,043,279 Compounds having selective activity for retinoid X receptors, and means for modulation of processes mediated by retinoid X receptors► Subscribe
6,610,883 Compounds having selective activity for retinoid X receptors, and means for modulation of processes mediated by retinoid X receptors► Subscribe
6,320,074 Compounds having selective activity for retinoid X receptors, and means for modulation of processes mediated by retinoid X receptors► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: bexarotene

Country Document Number Estimated Expiration
Luxembourg90803► Subscribe
World Intellectual Property Organization (WIPO)9321146► Subscribe
European Patent Office0983992► Subscribe
Germany69333371► Subscribe
Brazil9306284► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: BEXAROTENE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/041United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB01/041 GRANTED TO EISAI R + D MANAGEMENT., LTD. IN RESPECT OF THE PRODUCT BEXAROTENE (4-(1-(3, 5, 5, 8, 8-PENTAMETHYL-5, 6, 7, 8-TETRAHYDRO-2-NAPHTHALENYL)VINYL)BENZOIC ACID), WHICH WAS ADVERTISED AS COMING INTO FORCE IN JOURNAL NO 6469 DATED 15/05/2013 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, IT WILL EXPIRE ON 01/04/2016.
2001 00032Denmark► Subscribe
C013/2001Ireland► SubscribeSPC013/2001: 20031205, EXPIRES: 20160328
00054Netherlands► SubscribePRODUCT NAME: BEXAROTENE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVER- BINDING MET DE FORMULE R9OH, WAARIN R9 EEN; NAT. REGISTRATION NO/DATE: EU/1/01/178/001 20010329; FIRST REGISTRATION: EU/1/01/178/001 20010329
C0027France► SubscribePRODUCT NAME: BEXAROTENE; REGISTRATION NO/DATE: EU/1/01/178/001 20010329
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