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Serving leading biopharmaceutical companies globally:

Argus Health
Express Scripts
US Army
Mallinckrodt
Medtronic
Baxter
Chubb
McKesson
AstraZeneca
QuintilesIMS

Generated: February 21, 2018

DrugPatentWatch Database Preview

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

US Patents and Regulatory Information for isotretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Ny ISOTRETINOIN isotretinoin CAPSULE;ORAL 207792-001 Sep 29, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amneal Pharms Ny ISOTRETINOIN isotretinoin CAPSULE;ORAL 207792-004 Sep 29, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms Usa CLARAVIS isotretinoin CAPSULE;ORAL 076135-003 May 11, 2006 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-003 May 25, 2012 BX RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-003 May 7, 1982 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-004 May 25, 2012 BX RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sun Pharm Inds Ltd SOTRET isotretinoin CAPSULE;ORAL 076041-003 Dec 24, 2002 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms Usa CLARAVIS isotretinoin CAPSULE;ORAL 076135-001 Apr 11, 2003 AB RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms Usa CLARAVIS isotretinoin CAPSULE;ORAL 076356-001 Apr 11, 2003 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-001 May 25, 2012 BX RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for isotretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-002 May 7, 1982 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-003 May 7, 1982 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-003 May 7, 1982 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-003 May 7, 1982 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-002 May 7, 1982 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-002 May 7, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for isotretinoin

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Cantor Fitzgerald
Healthtrust
McKesson
Dow
Medtronic
Argus Health
Julphar
US Army

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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