OMAVELOXOLONE - Generic Drug Details

What are the generic sources for omaveloxolone and what is the scope of patent protection?

Omaveloxolone is the generic ingredient in one branded drug marketed by Biogen Us and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Omaveloxolone has ninety-eight patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for OMAVELOXOLONE

International Patents:	98
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	18
What excipients (inactive ingredients) are in OMAVELOXOLONE?	OMAVELOXOLONE excipients list
DailyMed Link:	OMAVELOXOLONE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OMAVELOXOLONE

Constraining patent/regulatory exclusivity:

TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OMAVELOXOLONE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Biogen	PHASE3
Biogen	PHASE1
Biogen	Phase 1

See all OMAVELOXOLONE clinical trials

Pharmacology for OMAVELOXOLONE

Mechanism of Action

Cytochrome P450 2C8 Inducers Cytochrome P450 3A4 Inducers

Anatomical Therapeutic Chemical (ATC) Classes for OMAVELOXOLONE

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for OMAVELOXOLONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	8,124,799			Y
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	11,091,430
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	9,701,709		Y	Y

International Patents for OMAVELOXOLONE

Country	Patent Number	Title	Estimated Expiration
Japan	2019011349	バルドキソロンメチルの２，２−ジフルオロプロピオンアミド誘導体、その多形体および使用方法 (2,2-DIFLUOROPROPIONAMIDE DERIVATIVES OF BARDOXOLONE METHYL, AND POLYMORPHIC FORMS AND METHODS OF USE THEREOF)
Hong Kong	1207086	甲基巴多索隆的 -二氟丙酰胺衍生物、其多晶型物及使用方法 (2,2-DIFLUOROPROPIONAMIDE DERIVATIVES OF BARDOXOLONE METHYL, POLYMORPHIC FORMS AND METHODS OF USE THEREOF 22-)
Hong Kong	1202552	抗氧化劑炎症調節劑：在 具有氨基和其它修飾的齊墩果酸衍生物 (ANTIOXIDANT INFLAMMATION MODULATORS: OLEANOLIC ACID DERIVATIVES WITH AMINO AND OTHER MODIFICATIONS AT C-17 C-17)
World Intellectual Property Organization (WIPO)	2013163344
Colombia	6311071	ANTIOXIDANTES MODULADORES DE LA INFLAMACION DERIVADOS DEL ACIDO OLEANOLICO CON ANIMO Y OTRAS MODIFICACIONES EN C-17

Supplementary Protection Certificates for OMAVELOXOLONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2841445	C02841445/01	Switzerland		PRODUCT NAME: OMAVELOXOLONUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69610 24.09.2024
2841445	CA 2024 00015	Denmark		PRODUCT NAME: OMAVELOXOLON ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/23/1786 20240212
2841445	24C1015	France		PRODUCT NAME: OMAVELOXOLONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/23/1786 20240212
2841445	CR 2024 00015	Denmark		PRODUCT NAME: OMAVELOXOLON ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/23/1786 20240212
2841445	C20240012	Finland

Market Dynamics and Financial Trajectory for Omaveloxolone

Last updated: February 19, 2026

Omaveloxolone, an investigational drug developed by Reata Pharmaceuticals, functions as a selective activator of Nrf2. It aims to address neurodegenerative disorders, primarily Friedreich’s Ataxia (FA). The drug's market prospects depend on regulatory approvals, clinical trial outcomes, competitive landscape, and pricing strategies.

Development Status and Regulatory Pathway

Omaveloxolone has advanced through multiple clinical phases. As of 2023, it received approval in the U.S. for Friedreich's Ataxia (FA):

• FDA Approval: August 2023 under the Accelerated Approval pathway, based on surrogate endpoints. The approval is contingent upon further confirmatory trials.
• Regulatory Strategy: Reata applied for full approval following Phase 3 data, which demonstrated significant improvement in neurological function metrics.

Additional submissions are under review in other regions, including the European Union and Japan, with timetables projected for 2024.

Market Potential in Friedreich’s Ataxia

FA is a rare, hereditary neurodegenerative disease characterized by impairments in gait, limb coordination, and speech. The disease primarily manifests in childhood or adolescence, with an estimated prevalence of 1 to 2 per 50,000 people.

• Market size estimation:

  • Global FA population: Approx. 25,000 (assuming 500,000 cases worldwide, with a 5% prevalence in the ataxia population).
  • Eligible patient population (presumed to be diagnosed): 20,000–25,000.
  • Addressable market (after considering treatment access and reimbursement): 15,000–20,000.

• Pricing assumptions:

  • Annual treatment cost: $150,000–$200,000, reflecting the rarity, specialized administration, and competitive pricing dynamics.

• Revenue estimates:

  • Year 1 (post-approval): $300–$400 million, assuming conservative uptake of 10–15%.
  • Over 5 years: Revenue could reach $1.5 billion, assuming steady growth and expansion into other indications or expanded access.

Competitive Landscape

Omaveloxolone's primary competitor was idebenone, marketed as Raxone (Industry's Orphan Drug), approved for Leber’s Hereditary Optic Neuropathy (LHON). Its use in FA was limited due to mixed efficacy data.

Upcoming pipeline candidates include:

• IFN-β-based therapies: Several ongoing trials targeting neurodegeneration.
• Gene therapy approaches: Emerging treatments with potential to transform FA management.

Competitive differentiation comes from omaveloxolone's mechanism of activating Nrf2, expected to reduce oxidative stress more effectively than competitors.

Financial Trajectory and Market Risks

• Reata Pharmaceuticals' financials:

  • 2022 revenue: $192 million, with a significant proportion from licensing and collaborations.
  • Expenses: High R&D costs ($150 million in 2022), reflecting ongoing clinical development.

• Growth assumptions:

  • Post-approval: Launch revenues could increase rapidly.
  • R&D pipeline success: Additional indications, such as pulmonary or cardiac conditions, could diversify revenue streams.

• Market risks:

  • Regulatory: Full approval depends on confirmatory trials.
  • Clinical: Long-term efficacy and safety remain under evaluation.
  • Commercial: Reimbursement policies and payor acceptance will influence sales.

Pricing and reimbursement strategies will determine access levels, impacting revenue realization.

Summary of Market Outlook

• Short Term (1-2 years): Focus on full approval, initial commercial launch, and establishing reimbursement pathways.
• Medium Term (3-5 years): Expansion into additional rare neurodegenerative indications or other metabolic disorders.
• Long Term (5+ years): Potential for pipeline diversification, including combination therapies, and broader market penetration.

Key Takeaways

• Omaveloxolone received accelerated approval for Friedreich’s Ataxia in 2023; full approval depends on confirmatory trial results.
• The addressable market for FA is approximately 20,000 patients globally, with annual revenues potentially reaching $400 million in early commercialization.
• Competition is limited but developing; the drug’s unique Nrf2 activation distinguishes it.
• Financial trajectory hinges on clinical success, regulatory approvals, market access, and pricing strategies.
• Risks include regulatory delays, clinical risks, and payer negotiations affecting market penetration.

FAQs

1. What is the primary therapeutic application of omaveloxolone?
   It is approved for treating Friedreich’s Ataxia, a rare neurodegenerative disorder.

2. When did omaveloxolone receive FDA approval?
   It gained accelerated approval in August 2023, with full approval pending validation.

3. What factors influence omaveloxolone’s market size?
   Disease prevalence, diagnosis rates, regulatory decisions, and access policies.

4. How does omaveloxolone compare to existing treatments?
   It offers a novel mechanism through Nrf2 activation, with efficacy demonstrated in clinical trials, unlike earlier therapies with limited success.

5. What are the main risks to its commercial success?
   Regulatory delays, safety concerns, competitive entrants, and reimbursement barriers.

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References

[1] Reata Pharmaceuticals. (2023). Omaveloxolone (Skyclarys) FDA approval announcement.
[2] Global Market Insights. (2023). Rare disease therapeutics market analysis.
[3] U.S. Food and Drug Administration. (2023). Accelerated approval pathways and medical product approvals.
[4] Orphanet. (2023). Friedreich’s ataxia prevalence and epidemiology.
[5] ClinicalTrials.gov. (2023). Clinical trials tracking for omaveloxolone and related therapies.