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SKYCLARYS Drug Patent Profile

Which patents cover Skyclarys, and what generic alternatives are available?

Skyclarys is a drug marketed by Reata Pharms and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and sixteen patent family members in thirty-seven countries.

The generic ingredient in SKYCLARYS is omaveloxolone. Two suppliers are listed for this compound. Additional details are available on the omaveloxolone profile page.

DrugPatentWatch^® Generic Entry Outlook for Skyclarys

Skyclarys will be eligible for patent challenges on February 28, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 28, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SKYCLARYS

International Patents:	116
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	1
Patent Applications:	52
Drug Prices:	Drug price information for SKYCLARYS
What excipients (inactive ingredients) are in SKYCLARYS?	SKYCLARYS excipients list
DailyMed Link:	SKYCLARYS at DailyMed

See drug prices for SKYCLARYS

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

Constraining patent/regulatory exclusivity:

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

NDA:

216718

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 SKYCLARYS

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

Sponsor	Phase
Biogen	Phase 1

See all SKYCLARYS clinical trials

Pharmacology for SKYCLARYS

Mechanism of Action

Cytochrome P450 2C8 Inducers Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for SKYCLARYS

SKYCLARYS is protected by eight US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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			Y	Y
Reata Pharms	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes			Y	Y
Reata Pharms	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes				Y
Reata Pharms	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718-001	Feb 28, 2023		RX	Yes	Yes

International Patents for SKYCLARYS

See the table below for patents covering SKYCLARYS around the world.

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

SKYCLARYS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SKYCLARYS

Introduction

SKYCLARYS (omaveloxolone), developed by Reata Pharmaceuticals, is a groundbreaking drug approved by the FDA for the treatment of Friedreich’s ataxia, a rare and progressive genetic disease affecting the nervous system. Here, we delve into the market dynamics and financial trajectory of this significant therapeutic advancement.

FDA Approval and Market Entry

SKYCLARYS received FDA approval in March 2023 for use in adults and adolescents aged 16 years and older, marking the first disease-specific treatment for Friedreich’s ataxia. This approval includes a rare pediatric disease priority review voucher, which can be used to expedite the review of a future drug application[1][3][4].

Pricing and Patient Access

Reata Pharmaceuticals set the wholesale acquisition price of SKYCLARYS at $370,000 annually. Despite the high cost, the company ensured that patients would face only nominal copays, making the treatment more accessible[1].

Market Potential and Patient Pool

The total addressable market for SKYCLARYS at launch is estimated to be approximately 4,500 patients in the U.S. Given the drug's unique position as the first and only FDA-approved treatment for Friedreich’s ataxia, it is poised to capture a significant market share. Market research indicates that about 95% of neurologists plan to prescribe SKYCLARYS within one year of its approval[1][2].

Clinical Evidence and Efficacy

SKYCLARYS was approved based on data from the placebo-controlled MOXIe Part 2 trial and the MOXIe Extension trial, which demonstrated improved function in patients compared to the placebo at Week 48. The modified Friedreich Ataxia Rating Scale was used to measure these improvements[1].

Financial Projections and Revenue

Revenue projections for SKYCLARYS are promising, with potential peak annual revenues estimated between $800 million and $1 billion. The drug's high price and orphan drug exclusivity, along with a pediatric review voucher, strengthen its competitive edge in the market[2][5].

Commercialization and Sales Infrastructure

Reata deployed a fully trained and experienced field sales team and established the necessary infrastructure to support the commercial launch of SKYCLARYS. By early 2023, the company had received approximately 500 patient start forms, indicating strong initial interest in the treatment[4].

Financial Standing and Funding

As of December 31, 2022, Reata had $42.3 million in cash and equivalents, along with marketable debt. Despite significant R&D and SG&A expenses, the company secured a $275 million non-dilutive debt facility, extending its cash runway through the end of 2026. This financial stability supports ongoing commercialization efforts and long-term studies for SKYCLARYS[2][4].

Regulatory Updates and Manufacturing

The FDA approved a Prior Approval Supplement to update the drug substance specification for SKYCLARYS, ensuring the drug's availability through specialty pharmacies by mid-August 2023. This regulatory approval was crucial for maintaining the drug's quality and compliance with applicable laws and regulations[3][4].

Side Effects and Safety Profile

Treatment with SKYCLARYS can cause changes in cholesterol levels, with 29% of patients reporting elevated cholesterol and 16% experiencing an increase in low-density lipoprotein cholesterol (LDL-C). However, these changes are generally manageable and return to baseline levels upon discontinuation of the treatment[3].

Acquisition by Biogen

In July 2023, Biogen announced its acquisition of Reata Pharmaceuticals for $7.3 billion, highlighting SKYCLARYS as a key asset with blockbuster potential. Biogen's global commercial infrastructure and expertise in rare diseases are expected to accelerate the delivery of SKYCLARYS to patients worldwide[5].

Market Impact and Competitive Edge

The acquisition by Biogen is seen as a strategic move to bolster Biogen's near-term growth trajectory, especially given the decline in its multiple sclerosis drug sales. SKYCLARYS, with its high margin and intellectual property protection beyond 2033, is expected to significantly add to Biogen's EPS starting in 2025[5].

Strategic Financial Management

Reata's financial strategy involves balancing expenses with commercialization efforts and securing funding avenues. The company's focus on neurology pipeline development and the discontinuation of other programs like bardoxolone for chronic kidney disease (CKD) align with its long-term growth objectives[4].

Future Outlook

With Biogen's acquisition, SKYCLARYS is positioned to become a standard of care for Friedreich’s ataxia. The drug's potential to exceed $1 billion in sales annually, combined with Biogen's commercial footprint, makes it a critical component of Biogen's rare disease portfolio. The financial trajectory of SKYCLARYS is expected to be robust, driven by its unique market position and the strong support from both Reata and Biogen[5].

Key Takeaways

• First FDA-Approved Treatment: SKYCLARYS is the first and only FDA-approved drug for Friedreich’s ataxia.
• High Market Potential: Estimated peak annual revenues between $800 million and $1 billion.
• Strong Commercial Support: Backed by Biogen's global commercial infrastructure.
• Regulatory Approvals: FDA approvals and updates ensure drug quality and compliance.
• Financial Stability: Reata's financial standing and Biogen's acquisition secure long-term growth.
• Clinical Efficacy: Demonstrated improved function in patients with Friedreich’s ataxia.

FAQs

Q: What is SKYCLARYS used for?

SKYCLARYS (omaveloxolone) is used for the treatment of Friedreich’s ataxia, a rare genetic disease affecting the nervous system.

Q: How much does SKYCLARYS cost?

The wholesale acquisition price of SKYCLARYS is $370,000 annually, although patients are expected to face only nominal copays.

Q: Who has acquired Reata Pharmaceuticals?

Biogen acquired Reata Pharmaceuticals for $7.3 billion in July 2023.

Q: What are the potential side effects of SKYCLARYS?

SKYCLARYS can cause changes in cholesterol levels, including elevated LDL-C and decreased HDL-C, but these changes are generally manageable.

Q: What is the estimated market size for SKYCLARYS?

The total addressable market for SKYCLARYS is estimated to be approximately 4,500 patients in the U.S.

Sources

1. Drug Discovery Trends: "Reata sets $370,000 annual cost for new nerve disorder drug"
2. Seeking Alpha: "Skyclarys' Positive Reception Bolsters Reata's Future (RETA)"
3. BioSpace: "Reata Pharmaceuticals Announces Approval of Prior Approval Supplement for SKYCLARYS"
4. BioSpace: "Reata Pharmaceuticals, Inc. Announces First Quarter 2023 Financial Results and Provides an Update on Operational Progress and Clinical Development Programs"
5. Genetic Engineering & Biotechnology News: "Biogen to Acquire Reata for $7.3B, Adding to Neuro Drug Portfolio"