Isotretinoin Patent Expiration
Isotretinoin was first introduced by Hoffmann La Roche Inc
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
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Clinical Trials
Recent Clinical Trials on Isotretinoin:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma | National Cancer Institute (NCI) | NA |
ACTIVE NOT RECRUITING
(Sep 1, 2026)
| PHASE1 |
| Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma | National Cancer Institute (NCI) | NA |
COMPLETED
(May 1, 2026)
| PHASE3 |
| Isotretinoin Versus Excimer Light an Adjuvant in Treating Onychomycosis | Zagazig University | NA |
RECRUITING
(Apr 1, 2026)
| PHASE1 |
| Isotretinoin vs hCG for Male Infertility Due to Low or Absent Sperm | University of Nebraska | NA |
ENROLLING BY INVITATION
(Apr 1, 2026)
| PHASE2 |
| Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells | New Approaches to Neuroblastoma Therapy Consortium | NA |
ACTIVE NOT RECRUITING
(Mar 1, 2026)
| PHASE1 |