Isotretinoin Patent Expiration

Isotretinoin was first introduced by Hoffmann La Roche Inc in its drug Accutane on May 7, 1982. Other drugs containing Isotretinoin are Absorica Ld, Absorica. 12 different companies have introduced drugs containing Isotretinoin.


Isotretinoin Patents

Given below is the list of patents protecting Isotretinoin, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Absorica Ld US9700535 Oral pharmaceutical composition of isotretinoin Aug 04, 2035 Sun Pharm
Absorica Ld US9750711 Low dose oral pharmaceutical composition of isotretinoin May 29, 2035 Sun Pharm
Absorica US7435427 Pharmaceutical semi-solid composition of isotretinoin Sep 21, 2021

(Expired)

Sun Pharm Inds Inc
Absorica US8367102 Pharmaceutical semi-solid composition of isotretinoin Sep 21, 2021

(Expired)

Sun Pharm Inds Inc
Absorica US8952064 Pharmaceutical semi-solid composition of isotretinoin Sep 21, 2021

(Expired)

Sun Pharm Inds Inc
Absorica US9078925 Pharmaceutical semi-solid composition of isotretinoin Sep 21, 2021

(Expired)

Sun Pharm Inds Inc
Absorica US9089534 Pharmaceutical semi-solid composition of isotretinoin Sep 21, 2021

(Expired)

Sun Pharm Inds Inc



Isotretinoin's Family Patents

Family Patents

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Isotretinoin Generic API Manufacturers

Several generic applications have been filed for Isotretinoin. The first generic version for Isotretinoin was by Mylan Pharmaceuticals Inc and was approved on Nov 8, 2002. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on May 22, 2025.

Given below is the list of companies who have filed for Isotretinoin generic, along with the locations of their manufacturing plants worldwide.