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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Accenture
QuintilesIMS
US Army
Dow
Julphar
Queensland Health
Argus Health
Daiichi Sankyo

Generated: October 17, 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 Ltd, Teva Pharms Usa, Mylan Pharms Inc, Sun Pharm Inds Inc, Hoffmann La Roche, Douglas Pharms, Amneal Pharms Ny, 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.

Summary for Generic Name: isotretinoin

US Patents:5
Tradenames:8
Applicants:8
NDAs:10
Drug Master File Entries: see list11
Suppliers / Packagers: see list7
Bulk Api Vendors: see list37
Clinical Trials: see list103
Patent Applications: see list7,489
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:isotretinoin at DailyMed

Pharmacology for Ingredient: isotretinoin

Ingredient-typeRetinoids
Drug ClassRetinoid
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc
ABSORICA
isotretinoin
CAPSULE;ORAL021951-001May 25, 2012BXRXYesNo► Subscribe► SubscribeY ► Subscribe
Teva Pharms Usa
CLARAVIS
isotretinoin
CAPSULE;ORAL076135-003May 11, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
ABSORICA
isotretinoin
CAPSULE;ORAL021951-002May 25, 2012BXRXYesNo► Subscribe► SubscribeY ► Subscribe
Hoffmann La Roche
ACCUTANE
isotretinoin
CAPSULE;ORAL018662-004Mar 28, 1983DISCNYesNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
CLARAVIS
isotretinoin
CAPSULE;ORAL076356-001Apr 11, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms Ny
ISOTRETINOIN
isotretinoin
CAPSULE;ORAL207792-004Sep 29, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
CLARAVIS
isotretinoin
CAPSULE;ORAL076135-002Apr 11, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
ABSORICA
isotretinoin
CAPSULE;ORAL021951-005Aug 15, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Sun Pharm Inds Inc
ABSORICA
isotretinoin
CAPSULE;ORAL021951-005Aug 15, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Douglas Pharms
MYORISAN
isotretinoin
CAPSULE;ORAL076485-002Jan 19, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: isotretinoin

International Patent Family for Ingredient: isotretinoin

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0224172► Subscribe
Canada2423170► Subscribe
Australia8943801► Subscribe
European Patent Office1318791► Subscribe
World Intellectual Property Organization (WIPO)2015094574► Subscribe
Austria270544► Subscribe
Portugal1318791► Subscribe
Germany60104206► Subscribe
Spain2225600► Subscribe
European Patent Office2964195► 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:

Harvard Business School
Cantor Fitzgerald
Boehringer Ingelheim
Fuji
Cipla
Healthtrust
Novartis
Colorcon
Teva
Daiichi Sankyo

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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