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Last Updated: November 21, 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
Insel Gruppe AG, University Hospital BernPhase 2
Chang Gung Memorial HospitalPhase 1/Phase 2
South Valley UniversityN/A

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
Sun Pharm ABSORICA LD isotretinoin CAPSULE;ORAL 211913-002 Nov 5, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Aurobindo Pharma ISOTRETINOIN isotretinoin CAPSULE;ORAL 218194-005 Jan 29, 2024 AB2 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma ISOTRETINOIN isotretinoin CAPSULE;ORAL 218194-004 Jan 29, 2024 AB2 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Upsher Smith Labs MYORISAN isotretinoin CAPSULE;ORAL 076485-002 Jan 19, 2012 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm ABSORICA LD isotretinoin CAPSULE;ORAL 211913-002 Nov 5, 2019 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

Expired US Patents for ISOTRETINOIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-003 May 7, 1982 ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-003 May 25, 2012 ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-005 Aug 15, 2014 ⤷  Sign Up ⤷  Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-005 Aug 15, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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