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Last Updated: March 28, 2024

Isotretinoin - Generic Drug Details


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What are the generic drug 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, Actavis Labs Fl, Amneal Pharms Ny, Aurobindo Pharma, Upsher Smith Labs, Zydus Pharms, Sun Pharm Inds Ltd, and Dr Reddys Labs Ltd, and is included in sixteen NDAs. There are two patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Isotretinoin has seventeen patent family members in nine countries.

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

Drug Prices for isotretinoin

See drug prices for isotretinoin

Recent Clinical Trials for isotretinoin

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

SponsorPhase
South Valley UniversityN/A
Tanta UniversityPhase 4
Assiut UniversityPhase 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 Strength NDA ANDAs Submitted Submissiondate
ABSORICA Capsules isotretinoin 25 mg 021951 1 2016-05-16
ABSORICA Capsules isotretinoin 35 mg 021951 1 2015-11-25
ABSORICA Capsules isotretinoin 10 mg 021951 1 2013-06-20
ABSORICA Capsules isotretinoin 20 mg 021951 1 2013-01-07
ABSORICA Capsules isotretinoin 40 mg 021951 1 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
Actavis Labs Fl ISOTRETINOIN isotretinoin CAPSULE;ORAL 205063-002 Mar 31, 2021 AB2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa CLARAVIS isotretinoin CAPSULE;ORAL 076135-002 Apr 11, 2003 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms ISOTRETINOIN isotretinoin CAPSULE;ORAL 211568-004 Aug 29, 2023 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-003 May 25, 2012 ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-006 Aug 15, 2014 ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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