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 Reata Pharms 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 one hundred and sixteen patent family members in thirty-seven countries.

Two suppliers are listed for this compound.

Summary for OMAVELOXOLONE

International Patents:	116
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	13
Patent Applications:	148
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	Phase 1
Reata, a wholly owned subsidiary of Biogen	Phase 1
altasciences	Phase 1

See all OMAVELOXOLONE clinical trials

Pharmacology for OMAVELOXOLONE

Mechanism of Action

Cytochrome P450 2C8 Inducers Cytochrome P450 3A4 Inducers

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
Reata Pharms	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes
Reata Pharms	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	9,701,709		Y	Y
Reata Pharms	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	8,124,799			Y
Reata Pharms	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	11,091,430
Reata Pharms	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes
Reata Pharms	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes	9,670,147			Y

International Patents for OMAVELOXOLONE

Country	Patent Number	Title	Estimated Expiration
South Korea	102101774
Canada	2721838	MODULATEURS D'INFLAMMATION ANTIOXYDANTS: DERIVES D'ACIDE OLEANOLIQUE PRESENTANT UNE MODIFICATION DU GROUPE AMINO ET D'AUTRES MODIFICATIONS EN C-17 (ANTIOXIDANT INFLAMMATION MODULATORS: OLEANOLIC ACID DERIVATIVES WITH AMINO AND OTHER MODIFICATIONS AT C-17)
South Korea	101735807
Eurasian Patent Organization	019263	АНТИОКСИДАТИВНЫЕ МОДУЛЯТОРЫ ВОСПАЛЕНИЯ: ПРОИЗВОДНЫЕ ОЛЕАНОЛЕВОЙ КИСЛОТЫ С АМИНОВЫМИ И ДРУГИМИ МОДИФИКАЦИЯМИ НА С-17 (ANTIOXIDANT INFLAMMATION MODULATORS: OLEANOLIC ACID DERIVATIVES WITH AMINO AND OTHER MODIFICATIONS AT C-17)
Colombia	6311071	ANTIOXIDANTES MODULADORES DE LA INFLAMACION DERIVADOS DEL ACIDO OLEANOLICO CON ANIMO Y OTRAS MODIFICACIONES EN C-17
Slovenia	2276493

OMAVELOXOLONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Omaveloxolone

Overview of Omaveloxolone

Omaveloxolone is a promising therapeutic agent under development for the treatment of Friedreich's ataxia, a rare genetic disorder that leads to progressive damage to the nervous system and movement difficulties. Here’s a detailed look at the market dynamics and financial trajectory surrounding this drug.

Clinical Development and Regulatory Status

Omaveloxolone, developed by Reata Pharmaceuticals, has shown significant promise in clinical trials. The drug was granted fast track designation, orphan drug designation in the U.S. and Europe, and is eligible for priority review and accelerated approval[5].

Clinical Trial Outcomes

Clinical trials, particularly the MOXIe study, demonstrated that omaveloxolone is generally safe and well-tolerated. It significantly improved multiple measures of neurological function and patients’ ability to engage in daily activities. Although the FDA initially stated that the results were insufficient for regulatory approval, a petition by the Friedreich’s Ataxia Research Alliance led to a reconsideration, and Reata decided to apply for standard approval without additional clinical trial data[5].

Market Potential and Growth Drivers

The market for Friedreich's ataxia treatments is expected to grow substantially, driven by several factors:

Increasing Prevalence and Need for Effective Treatments

Friedreich's ataxia affects about 1 in every 50,000 people in the United States, and the increasing prevalence of the disease, combined with the urgent need for effective treatments, is a key driver of market growth[1].

Advancements in Genetic Research and Biotechnology

Advancements in genetic research and biotechnology have spurred the development of novel therapeutic approaches, including gene therapy and disease-modifying treatments. Omaveloxolone, as a Nrf2 activator, represents one of these innovative approaches[4].

Robust Support from Organizations

Growing awareness among healthcare professionals and patients, along with robust support from governmental and non-governmental organizations for rare disease research, has significantly contributed to market growth[1].

Financial Trajectory

Acquisition by Biogen

Biogen's acquisition of Reata Pharmaceuticals for $7.3 billion is a significant financial milestone for omaveloxolone. This acquisition is expected to bolster Biogen's neurological drug portfolio and provide the necessary resources to accelerate the delivery of omaveloxolone to patients worldwide[2].

Projected Sales and Revenue

Analysts estimate that omaveloxolone, now known as Skyclarys, has the potential to be a “blockbuster” drug with sales exceeding $1 billion. Peak sales are estimated to be around $1.5-2 billion for the U.S. and outside the U.S., indicating a high margin for the drug given its rare disease indication and extended intellectual property protection[2].

Impact on Biogen's Financials

Biogen expects the acquisition to slightly lower its non-GAAP diluted earnings per share (EPS) in the current year but to be neutral in 2024 and significantly add to EPS starting in 2025. This suggests a positive long-term financial outlook for omaveloxolone under Biogen's stewardship[2].

Challenges and Opportunities

Market Access and Reimbursement

Despite the promising market potential, challenges such as unaffordable pricing, market access, and reimbursement issues could impact the drug's adoption. However, Biogen's existing commercial infrastructure and expertise in rare diseases are expected to mitigate these challenges[1].

Competitive Landscape

The Friedreich's ataxia market is becoming increasingly competitive with several other therapies in development, such as RT001, Vatiquinone, and Leriglitazone. However, omaveloxolone's unique mechanism of action and the support from a major pharmaceutical company like Biogen position it favorably in the market[1].

Key Takeaways

• Omaveloxolone has shown significant clinical promise in treating Friedreich's ataxia.
• The drug has received fast track and orphan drug designations, facilitating its regulatory approval process.
• Biogen's acquisition of Reata Pharmaceuticals is expected to accelerate the drug's delivery and enhance its market potential.
• Projected sales indicate blockbuster potential, with peak sales estimated at $1.5-2 billion.
• Despite challenges, Biogen's expertise and commercial footprint are expected to drive the drug's success.

FAQs

Q: What is omaveloxolone, and what is it used for?

Omaveloxolone is a therapeutic agent developed for the treatment of Friedreich's ataxia, a rare genetic disorder affecting the nervous system.

Q: What is the current regulatory status of omaveloxolone?

Omaveloxolone has received fast track and orphan drug designations and is under review for standard approval by the FDA without additional clinical trial data.

Q: Who acquired Reata Pharmaceuticals, the developer of omaveloxolone?

Biogen acquired Reata Pharmaceuticals for $7.3 billion to bolster its neurological drug portfolio.

Q: What are the projected sales for omaveloxolone?

Analysts estimate peak sales of $1.5-2 billion for the U.S. and outside the U.S., indicating blockbuster potential.

Q: What challenges might omaveloxolone face in the market?

Challenges include unaffordable pricing, market access, and reimbursement issues, although Biogen's expertise is expected to help overcome these.

Cited Sources

1. GlobeNewswire: Friedreich's Ataxia Market to Grow at a Substantial Growth Rate by 2034, Examines DelveInsight | Key Companies - Retrotope, PTC Therapeutics, Minoryx Therapeutics, Biogen, Lexeo Therapeutics, Larimar Therapeutics.
2. Genetic Engineering & Biotechnology News: Biogen to Acquire Reata for $7.3B, Adding to Neuro Drug Portfolio.
3. GlobeNewswire: Reata Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2020 Financial Results and Provides an Update on Clinical Development Programs.
4. FDA: 216718Orig1s000 CLINICAL REVIEW(S).
5. Friedreich's Ataxia News: Rolling FDA Submission of FA Therapy Omaveloxolone Completed.