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Serving leading biopharmaceutical companies globally:

Mallinckrodt
US Department of Justice
Teva
Merck
Healthtrust
Moodys
Julphar
Citi
Novartis
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Generated: December 11, 2017

DrugPatentWatch Database Preview

Bexarotene - Generic Drug Details

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What are the generic sources for bexarotene and what is the scope of bexarotene patent protection?

Bexarotene
is the generic ingredient in two branded drugs marketed by Bionpharma Inc and Valeant Luxembourg, 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.

Bexarotene has fifty-five patent family members in seventeen countries and five supplementary protection certificates in five countries.

There are six drug master file entries for bexarotene. Four suppliers are listed for this compound.

Pharmacology for bexarotene

Ingredient-typeRetinoids
Drug ClassRetinoid
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Bionpharma IncBEXAROTENEbexaroteneCAPSULE;ORAL203174-001Aug 12, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneCAPSULE;ORAL021055-001Dec 29, 1999ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneCAPSULE;ORAL021055-001Dec 29, 1999ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneGEL;TOPICAL021056-001Jun 28, 2000RXYesYes► Subscribe► Subscribe► 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 LuxembourgTARGRETINbexaroteneGEL;TOPICAL021056-001Jun 28, 2000► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneGEL;TOPICAL021056-001Jun 28, 2000► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneCAPSULE;ORAL021055-001Dec 29, 1999► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneGEL;TOPICAL021056-001Jun 28, 2000► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneGEL;TOPICAL021056-001Jun 28, 2000► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneCAPSULE;ORAL021055-001Dec 29, 1999► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneCAPSULE;ORAL021055-001Dec 29, 1999► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneCAPSULE;ORAL021055-001Dec 29, 1999► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneCAPSULE;ORAL021055-001Dec 29, 1999► Subscribe► Subscribe
Valeant LuxembourgTARGRETINbexaroteneGEL;TOPICAL021056-001Jun 28, 2000► Subscribe► 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
5,780,676 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
7,655,699Compounds 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
6,043,279 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
European Patent Office0678086► Subscribe
World Intellectual Property Organization (WIPO)9321146► Subscribe
Denmark0678086► Subscribe
Greece3032841► Subscribe
Austria177733► Subscribe
Greece3034841► Subscribe
Germany69333894► Subscribe
World Intellectual Property Organization (WIPO)9504036► Subscribe
Portugal678086► Subscribe
Norway943943► 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
C0027France► SubscribePRODUCT NAME: BEXAROTENE; REGISTRATION NO/DATE: EU/1/01/178/001 20010329
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
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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Deloitte
Novartis
Daiichi Sankyo
Federal Trade Commission
US Army
Merck
US Department of Justice
McKinsey
Citi

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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