Omaveloxolone Patent Expiration
Omaveloxolone is used for treating Friedrich's ataxia by activating the NRF2 pathway to reduce oxidative stress in adults and adolescents aged 16 years and older. It was first introduced by Biogen Us Corporation
Omaveloxolone Patents
Given below is the list of patents protecting Omaveloxolone, 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 |
|---|---|---|---|---|
| Skyclarys | US8993640 | 2,2-difluoropropionamide derivatives of bardoxolone methyl, polymorphic forms and methods of use thereof | Apr 24, 2033 | Biogen Us |
| Skyclarys | US9701709 | 2,2-difluoropropionamide derivatives of bardoxolone methyl, polymorphic forms and methods of use thereof | Apr 24, 2033 | Biogen Us |
| Skyclarys | US8124799 | Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17 | Dec 03, 2029 | Biogen Us |
| Skyclarys | US11091430 | Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at c-17 | Apr 20, 2029 | Biogen Us |
| Skyclarys | US11919838 | Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17 | Apr 20, 2029 | Biogen Us |
| Skyclarys | US8440854 | Antioxidant inflammation modulators: oleanolic acid derivatives with amino acid and other modifications at C-17 | Apr 20, 2029 | Biogen Us |
| Skyclarys | US9670147 | Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17 | Apr 20, 2029 | Biogen Us |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or
decrease the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that
drug. Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in
the patent process of
the drug which can give an idea of how early a drug's generic could be available. The next
section provides a list
of recent legal activities on Omaveloxolone's patents.
Latest Legal Activities on Omaveloxolone's Patents
Given below is the list recent legal activities going on the following patents of Omaveloxolone.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| FDA Final Eligibility Letter | 17 Dec, 2025 | US8993640 |
| FDA Final Eligibility Letter | 17 Dec, 2025 | US8440854 |
| FDA Final Eligibility Letter | 17 Dec, 2025 | US9670147 |
| FDA Final Eligibility Letter | 17 Dec, 2025 | US9701709 |
| FDA Final Eligibility Letter | 17 Dec, 2025 | US8124799 |
| FDA Final Eligibility Letter | 17 Dec, 2025 | US11091430 |
| Information Disclosure Statement (IDS) Filed | 12 May, 2025 | US8124799 |
| transaction for FDA Determination of Regulatory Review Period | 12 May, 2025 | US8124799 |
| transaction for FDA Determination of Regulatory Review Period | 12 May, 2025 | US8440854 |
| transaction for FDA Determination of Regulatory Review Period | 12 May, 2025 | US11091430 |
Omaveloxolone's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Omaveloxolone:
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 |
|---|---|---|---|---|
 | ||||
| A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old | Biogen | NA |
ACTIVE NOT RECRUITING
(Sep 1, 2026)
| PHASE1 |
| A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia | Biogen | NA |
COMPLETED
(Aug 1, 2026)
| PHASE2 |
| A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich's Ataxia | Biogen | NA |
RECRUITING
(Jun 1, 2026)
| PHASE3 |
| A Study to Learn How the Body Processes BIIB141 (Omaveloxolone) When Taken as a Capsule or as a Tablet Dissolved in Liquid, and to Learn About Its Safety in Healthy Adults Ages 18 to 55 | Biogen | NA |
COMPLETED
(May 1, 2026)
| PHASE1 |