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Last Updated: February 27, 2021

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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 freedom to operate?

Isotretinoin is the generic ingredient in nine branded drugs marketed by Sun Pharm Inds Inc, Sun Pharm, 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 eleven NDAs. There are seven patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Isotretinoin has twenty-nine patent family members in thirteen countries.

There are thirteen drug master file entries for isotretinoin. Six suppliers are listed for this compound.

Drug Prices for isotretinoin

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Recent Clinical Trials for isotretinoin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of PennsylvaniaPhase 4
Medical University of South CarolinaPhase 1/Phase 2
Beth Israel Deaconess Medical CenterPhase 4

See all isotretinoin clinical trials

Pharmacology for isotretinoin
Drug ClassRetinoid
Medical Subject Heading (MeSH) Categories for isotretinoin
Paragraph IV (Patent) Challenges for ISOTRETINOIN
Tradename Dosage Ingredient NDA Submissiondate
ABSORICA CAPSULE;ORAL isotretinoin 021951 2016-05-16
ABSORICA CAPSULE;ORAL isotretinoin 021951 2015-11-25
ABSORICA CAPSULE;ORAL isotretinoin 021951 2013-06-20
ABSORICA CAPSULE;ORAL isotretinoin 021951 2013-06-19
ABSORICA CAPSULE;ORAL isotretinoin 021951 2013-01-07
ABSORICA CAPSULE;ORAL isotretinoin 021951 2012-12-31

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
Sun Pharm ABSORICA LD isotretinoin CAPSULE;ORAL 211913-006 Nov 5, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Pharms Usa CLARAVIS isotretinoin CAPSULE;ORAL 076356-001 Apr 11, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd SOTRET isotretinoin CAPSULE;ORAL 076503-001 Jun 20, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
McKesson
Colorcon
Johnson and Johnson
Medtronic

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