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FDA Orange Book · active-ingredient family

Isotretinoin

Isotretinoin is approved as 3 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ABSORICA LD · NDA 211913

3

Brand (NDA)

15

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
ABSORICA LDRLD×6SUN PHARMNDA 211913—Nov 05, 2019
ABSORICARLD×6SUN PHARM INDS INCNDA 021951AB2May 25, 2012
ACCUTANERLD×3HOFFMANN LA ROCHENDA 018662—May 07, 1982

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
ISOTRETINOIN×6AMNEAL PHARMS NYANDA 216097—Oct 07, 2025
ISOTRETINOIN×6ZYDUS PHARMSANDA 216633AB2May 22, 2025
ISOTRETINOIN×6AUROBINDO PHARMAANDA 218194AB2Jan 29, 2024
ISOTRETINOIN×4ZYDUS PHARMSANDA 211568AB1Aug 29, 2023
ISOTRETINOIN×3UPSHER SMITH LABSANDA 212333AB2Sep 21, 2021
ISOTRETINOINUPSHER SMITH LABSANDA 213571AB2Apr 12, 2021
ISOTRETINOIN×6ACTAVIS LABS FLANDA 205063AB2Mar 31, 2021
ISOTRETINOIN×4AMNEAL PHARMS NYANDA 207792AB1Sep 29, 2017
ZENATANE×4DR REDDYS LABS LTDANDA 202099AB1Mar 25, 2013
MYORISAN×4UPSHER SMITH LABSANDA 076485AB1Jan 19, 2012
SOTRETSUN PHARM INDS LTDANDA 076503—Jun 20, 2003
CLARAVISTEVA PHARMS USAANDA 076356AB1Apr 11, 2003
CLARAVIS×3TEVA PHARMS USAANDA 076135AB1Apr 11, 2003
SOTRET×3SUN PHARM INDS LTDANDA 076041—Dec 24, 2002
AMNESTEEM×4MYLAN PHARMS INCANDA 075945AB1Nov 08, 2002

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9750711May 29, 2035in 9 yr 1 mo
Product
9700535Aug 04, 2035in 9 yr 3 mo
Product

Isotretinoin — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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