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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Covington
US Army
Mallinckrodt
Johnson and Johnson
Moodys
Novartis
Argus Health
Deloitte
Teva

Generated: December 12, 2017

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Isotretinoin - Generic Drug Details

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

Isotretinoin
is the generic ingredient in eight branded drugs marketed by Sun Pharm Inds Inc, Hoffmann La Roche, Mylan Pharms Inc, Teva Pharms Usa, Amneal Pharms Ny, Douglas Pharms, Sun Pharm Inds Ltd, and Dr Reddys Labs Ltd, and is included in ten NDAs. There are five patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Isotretinoin has eleven patent family members in eight countries.

There are eleven drug master file entries for isotretinoin. Seven suppliers are listed for this compound.

Pharmacology for isotretinoin

Ingredient-typeRetinoids
Drug ClassRetinoid

Medical Subject Heading (MeSH) Categories for isotretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds LtdSOTRETisotretinoinCAPSULE;ORAL076503-001Jun 20, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm Inds IncABSORICAisotretinoinCAPSULE;ORAL021951-002May 25, 2012BXRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sun Pharm Inds IncABSORICAisotretinoinCAPSULE;ORAL021951-006Aug 15, 2014RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Douglas PharmsMYORISANisotretinoinCAPSULE;ORAL076485-002Jan 19, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdZENATANEisotretinoinCAPSULE;ORAL202099-004Feb 23, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncAMNESTEEMisotretinoinCAPSULE;ORAL075945-001Nov 8, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm Inds IncABSORICAisotretinoinCAPSULE;ORAL021951-001May 25, 2012BXRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Amneal Pharms NyISOTRETINOINisotretinoinCAPSULE;ORAL207792-004Sep 29, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm Inds IncABSORICAisotretinoinCAPSULE;ORAL021951-004May 25, 2012BXRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Douglas PharmsMYORISANisotretinoinCAPSULE;ORAL076485-003Jan 19, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: isotretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-004Mar 28, 1983► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-002May 7, 1982► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-003May 7, 1982► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-003May 7, 1982► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-004Mar 28, 1983► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-004Mar 28, 1983► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-003May 7, 1982► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-004Mar 28, 1983► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-002May 7, 1982► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-002May 7, 1982► Subscribe► Subscribe
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International Patent Family for Ingredient: isotretinoin

Country Document Number Estimated Expiration
Australia8943801► Subscribe
European Patent Office2964195► Subscribe
Canada2423170► Subscribe
World Intellectual Property Organization (WIPO)0224172► Subscribe
Portugal1318791► Subscribe
Austria270544► Subscribe
World Intellectual Property Organization (WIPO)2015094574► Subscribe
Canada2836228► Subscribe
European Patent Office1318791► Subscribe
Spain2225600► 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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Serving leading biopharmaceutical companies globally:

Medtronic
QuintilesIMS
Johnson and Johnson
Farmers Insurance
Novartis
Moodys
AstraZeneca
US Army
Deloitte
Chinese Patent Office

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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