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Last Updated: November 2, 2024

ISOTRETINOIN Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Isotretinoin

A generic version of ISOTRETINOIN was approved as isotretinoin by AMNEAL PHARMS NY on September 29th, 2017.

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Drug patent expirations by year for ISOTRETINOIN
Drug Prices for ISOTRETINOIN

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Recent Clinical Trials for ISOTRETINOIN

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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
Actavis Labs Fl ISOTRETINOIN isotretinoin CAPSULE;ORAL 205063-001 Mar 31, 2021 AB2 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Upsher Smith Labs ISOTRETINOIN isotretinoin CAPSULE;ORAL 212333-002 Sep 21, 2021 AB2 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms ISOTRETINOIN isotretinoin CAPSULE;ORAL 211568-004 Aug 29, 2023 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms Ny ISOTRETINOIN isotretinoin CAPSULE;ORAL 207792-001 Sep 29, 2017 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  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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