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Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Cipla
Chinese Patent Office
Healthtrust
Merck
Federal Trade Commission
US Department of Justice
McKesson
McKinsey

Generated: December 10, 2017

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ABSORICA Drug Profile

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When do Absorica patents expire, and what generic alternatives are available?

Absorica is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. There are five patents protecting this drug and five Paragraph IV challenges.

This drug has eleven patent family members in eight countries.

The generic ingredient in ABSORICA is isotretinoin. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Drug patent expirations by year for ABSORICA

Pharmacology for ABSORICA

Ingredient-typeRetinoids
Drug ClassRetinoid

Medical Subject Heading (MeSH) Categories for ABSORICA

US Patents and Regulatory Information

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 IncABSORICAisotretinoinCAPSULE;ORAL021951-004May 25, 2012BXRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sun Pharm Inds IncABSORICAisotretinoinCAPSULE;ORAL021951-004May 25, 2012BXRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sun Pharm Inds IncABSORICAisotretinoinCAPSULE;ORAL021951-001May 25, 2012BXRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sun Pharm Inds IncABSORICAisotretinoinCAPSULE;ORAL021951-003May 25, 2012BXRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sun Pharm Inds IncABSORICAisotretinoinCAPSULE;ORAL021951-006Aug 15, 2014RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sun Pharm Inds IncABSORICAisotretinoinCAPSULE;ORAL021951-002May 25, 2012BXRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sun Pharm Inds IncABSORICAisotretinoinCAPSULE;ORAL021951-001May 25, 2012BXRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sun Pharm Inds IncABSORICAisotretinoinCAPSULE;ORAL021951-005Aug 15, 2014RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Sun Pharm Inds IncABSORICAisotretinoinCAPSULE;ORAL021951-003May 25, 2012BXRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm Inds IncABSORICAisotretinoinCAPSULE;ORAL021951-002May 25, 2012BXRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for ABSORICA

Drugname Dosage Strength RLD Submissiondate
isotretinoinCapsules25 mgAbsorica5/16/2016
isotretinoinCapsules35 mgAbsorica11/25/2015
isotretinoinCapsules30 mg and 40 mgAbsorica12/31/2012
isotretinoinCapsules20 mgAbsorica1/7/2013
isotretinoinCapsules20 mgAbsorica6/19/2013

International Patent Family for Tradename: ABSORICA

Country Document Number Estimated Expiration
European Patent Office1318791► Subscribe
Canada2836228► Subscribe
Canada2423170► Subscribe
Germany60104206► Subscribe
World Intellectual Property Organization (WIPO)0224172► Subscribe
World Intellectual Property Organization (WIPO)2015094574► Subscribe
Spain2225600► Subscribe
Australia8943801► Subscribe
Portugal1318791► 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:

Teva
AstraZeneca
Boehringer Ingelheim
Julphar
Harvard Business School
Merck
Novartis
McKinsey
Federal Trade Commission
Queensland Health

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