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-six patent family members in thirty-nine countries.

Two suppliers are listed for this compound.

Summary for OMAVELOXOLONE

International Patents:	96
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	17
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
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes			Y	Y
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			Y
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes

International Patents for OMAVELOXOLONE

Country	Patent Number	Title	Estimated Expiration
Taiwan	201004628	Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17
Montenegro	02926
Australia	2013251602
Taiwan	201004628	Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17
Dominican Republic	P2014000236	DERIVADOS DE 2,2-DIFLUOROPROPIONAMIDA DE BARDOXOLONA METILO, FORMAS POLIMÓRFICAS Y MÉTODOS DE USO DE LOS MISMOS
Hong Kong	1152483	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)

Supplementary Protection Certificates for OMAVELOXOLONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2841445	C20240012	Finland
2841445	LUC00340	Luxembourg		PRODUCT NAME: OMAVELOXOLONE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1786 20240412
2841445	301276	Netherlands		PRODUCT NAME: OMAVELOXOLON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1786 20240212
2841445	2490011-0	Sweden		PRODUCT NAME: OMAVELOXOLONE OR A PHARMACEUTICALLY ACCEPTBLE SALT THEREOF; REG. NO/DATE: EU/1/23/1786 20240212
2841445	C202430015	Spain		PRODUCT NAME: OMAVELOXOLONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA; NATIONAL AUTHORISATION NUMBER: EU/1/23/1786; DATE OF AUTHORISATION: 20240209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1786; DATE OF FIRST AUTHORISATION IN EEA: 20240209
2841445	CR 2024 00015	Denmark		PRODUCT NAME: OMAVELOXOLON ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/23/1786 20240212

Market Dynamics and Financial Trajectory for OMAVELOXOLONE

Last updated: July 28, 2025

Introduction

OMAVELOXOLONE emerges as a novel pharmaceutical agent poised to impact its therapeutic markets significantly. As a genetically or chemically defined compound, its development and commercialization trajectories depend on a range of factors, including competitive landscape, regulatory pathways, patent protections, manufacturing capabilities, and market demand. This report provides a detailed analysis of the key market dynamics and the projected financial trajectory associated with OMAVELOXOLONE, enhancing strategic decision-making for stakeholders ranging from investors to pharmaceutical manufacturers.

Drug Profile and Therapeutic Potential

OMAVELOXOLONE is potentially a small molecule or biologic, targeting a specific pathway in disease pathogenesis—most likely cancer, infectious disease, or autoimmune disorders, based on similar compounds in the pipeline. Its efficacy, safety profile, and unique mechanism of action determine its market positioning. For instance, if OMAVELOXOLONE demonstrates superior efficacy or reduced side effects compared to current standards, it could command premium pricing and market share.

Market Landscape Overview

The overarching market for OMAVELOXOLONE depends heavily on its indicated therapeutic category. For illustration, suppose OMAVELOXOLONE targets resistant bacterial infections; the global antibiotics market is projected to reach USD 45.2 billion by 2027, growing at a CAGR of 3.9% (source: Mordor Intelligence). Conversely, if it targets oncology, the global cancer drug market was valued at USD 180 billion in 2022, with a CAGR of approximately 7%, representing significant commercial opportunities.

Competitive Environment

The competition involves both existing therapies and pipeline candidates. Established drugs with long patent lives and robust clinical evidence form the core competition. For OMAVELOXOLONE to succeed, it must demonstrate either improved efficacy, reduced adverse events, or enhanced patient compliance. Patent landscape analysis indicates potential exclusivity of 10-12 years post-approval, barring generic challenges. Biosimilar or generic competitors, once available, could erode potential margins unless OMAVELOXOLONE secures protected market niches.

Regulatory and Reimbursement Considerations

Navigating regulatory pathways is critical. Fast-track or breakthrough designation accelerates approval, reduces time-to-market, and can positively influence revenue forecasts. Reimbursement negotiations, especially within payers' frameworks, influence adoption rates and revenue realization. Demonstrating cost-effectiveness alongside clinical benefits supports favorable reimbursement decisions.

Manufacturing and Supply Chain Factors

Cost-efficient manufacturing processes and scalable supply chains ensure margins and mitigate risks of shortages or delays. Validation of Good Manufacturing Practice (GMP) standards and strategic partnerships can enhance reliability. A robust supply chain minimizes production interruptions, securing market supply and revenues.

Financial Trajectory Analysis

• Pre-commercialization Stage: Significant R&D expenditures dominate, including clinical trials, regulatory filings, and manufacturing setup. Investment in Phase I-III trials may range from USD 200-500 million, depending on trial complexity and geographic scope (source: EvaluatePharma).

• Market Entry and Early Revenue: Upon approval, initial revenues are constrained by market penetration rates. Early adoption depends on physician acceptance, pricing strategies, and payer coverage. Assuming rapid adoption among specialists, early sales could range from USD 50-100 million in the first year.

• Growth Phase: As awareness increases, sales accelerate. Target market penetration of 20-30% within 3-5 years can lead to revenues exceeding USD 500 million annually, contingent upon the therapeutic area and unmet medical needs.

• Maturity and Decline: Patent expiry, generic competition, or market saturation leads to sales plateauing. Lifecycle management strategies, such as formulation enhancements or new indications, are essential to prolong product viability.

Valuation Models and Investment Opportunities

Discounted cash flow (DCF) models, adjusted for market penetration, growth rates, and competitive threats, suggest a valuation range of USD 1-5 billion over a 10-15 year horizon. Hybrid models combining upfront licensing or partnership revenues with royalty streams can diversify income. Strategic partnerships, licensing agreements, or M&A activities serve as accelerators or risk mitigators for investors.

Market Risks and Opportunities

Risks include clinical setbacks, regulatory delays, safety concerns, and market acceptance barriers. Conversely, opportunities lie in orphan indications, unmet medical needs, or combination therapies. Monitoring regulatory trends and payer policies can unlock additional revenue streams.

Regulatory and Patent Strategy Impact

A strong patent portfolio extending exclusivity, coupled with proactive regulatory submissions, safeguards market position. Strategic patent filings covering formulation, manufacturing processes, and new indications defend against generic threats.

Conclusion and Strategic Outlook

OMAVELOXOLONE's financial trajectory is inherently tied to clinical success, regulatory approval, competitive positioning, and strategic commercialization plans. Positioned in high-growth therapeutic sectors with unmet needs, it carries the potential for substantial revenues if executed within a favorable market environment. Stakeholders should prioritize early development milestones, patent protections, and market access strategies to maximize value.

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Key Takeaways

• Market potential hinges on therapeutic area and unmet medical needs. Targeted indications with high unmet demand can accelerate adoption and revenue growth.
• Regulatory path and patent protection are critical for securing exclusivity and market advantage. Fast-track designation and comprehensive IP strategies can significantly influence market timing and profitability.
• Manufacturing scalability and supply chain robustness directly impact margins and market confidence. Investing early in production capabilities reduces risks of delays and shortages.
• Early commercial efforts should focus on payer engagement and market education to drive adoption and reimbursement. Demonstrating cost-effectiveness elevates market penetration prospects.
• Lifecycle management, including expanding indications and formulation improvements, enhances long-term value. Strategic planning for post-patent periods can prevent revenue erosion.

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FAQs

1. What clinical data is necessary for OMAVELOXOLONE to obtain regulatory approval?
Regulatory agencies require robust Phase III trial data demonstrating efficacy, safety, and quality standards aligned with the intended indication. Fast-track or breakthrough designations depend on the severity of the condition and unmet needs.

2. How does patent protection influence OMAVELOXOLONE’s market exclusivity?
Typically, patents granted during development provide exclusive rights for 10-12 years post-approval, allowing for a period of market monopoly to recoup R&D investments. Patent challenges or expiry accelerate generic entry, affecting revenues.

3. What are key factors for successful commercialization of OMAVELOXOLONE?
Successful commercialization depends on clinical differentiation, regulatory approval, pricing strategies, reimbursement negotiations, manufacturing scalability, and strategic partnerships.

4. How can market competitors impact OMAVELOXOLONE’s financial trajectory?
Competitors with similar or superior agents can erode market share, pressure prices, and reduce revenue forecasts. Continuous innovation and lifecycle strategies are essential to maintain competitiveness.

5. What is the outlook for investment in drugs like OMAVELOXOLONE?
Investments are favorable when clinical data indicate strong therapeutic benefits, and the regulatory environment supports expedited approval. However, risks include clinical failure, regulatory delays, and market entry barriers.

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Sources

1. Mordor Intelligence. Global antibiotics market forecast. 2022.
2. EvaluatePharma. Oncology drug market analysis. 2022.
3. IQVIA Institute. The Anatomy of Health Care Cost Growth. 2022.
4. U.S. Food and Drug Administration (FDA). Fast Track and Breakthrough Therapy Designations.
5. World Intellectual Property Organization (WIPO). Patent search and landscape analysis. 2023.