SKYCLARYS Drug Patent Profile

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

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

This drug has ninety-six patent family members in thirty-nine 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:	96
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	5
Patent Applications:	218
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	PHASE3
Biogen	PHASE1
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 three 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
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			Y	Y
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 SKYCLARYS

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

Country	Patent Number	Title	Estimated Expiration
Canada	2869783
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)
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)
Dominican Republic	P2014000236	DERIVADOS DE 2,2-DIFLUOROPROPIONAMIDA DE BARDOXOLONA METILO, FORMAS POLIMÓRFICAS Y MÉTODOS DE USO DE LOS MISMOS
Colombia	6311071

Supplementary Protection Certificates for SKYCLARYS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2841445	301276	Netherlands		PRODUCT NAME: OMAVELOXOLON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION 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	CA 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 SKYCLARYS

Last updated: July 27, 2025

---

Introduction

SKYCLARYS (soticlestat) emerges as a promising pharmaceutical agent targeting rare neurological disorders, notably Dravet syndrome and Lennox-Gastaut syndrome (LGS). Approved by the US Food and Drug Administration (FDA) in August 2023, SKYCLARYS marks a significant advancement in the realm of epilepsy management, promising therapeutic benefits for a niche yet vulnerable patient group. Understanding the market dynamics and financial trajectory of SKYCLARYS requires a nuanced analysis of the drug's therapeutic profile, competitive landscape, payer dynamics, regulatory environment, and key growth catalysts.

---

Therapeutic Profile and Market Opportunity

SKYCLARYS operates as a brain-selective T-type calcium channel inhibitor, addressing the hyperexcitability underlying severe epileptic syndromes. The drug’s approval for Dravet syndrome and LGS positions it within a high-need segment characterized by refractory epilepsy cases often resistant to established therapies such as valproate, topiramate, and Clobazam.

The prevalence of Dravet syndrome is approximately 1 in 15,700 to 40,000 live births globally, translating into an estimated 3,000–4,000 cases annually in the United States alone, with similar figures in Europe and other developed markets. LGS incidence, estimated at about 1–2 per 1,000 children with epilepsy, further expands the addressable market, which, despite its rarity, commands substantial treatment expenditures owing to the severity and treatment resistance (source: [1], [2]).

Given these epidemiological factors, SKYCLARYS’s initial market size is modest but significant, especially considering the high unmet need in these populations. The drug’s targeted mechanism signals potential preferential positioning over off-label or less specific anti-epileptic therapies.

---

Market Dynamics

Competitive Landscape

The epilepsy treatment domain hosts a mixture of established drugs—including valproate, lamotrigine, clobazam, and cannabidiol formulations like Epidiolex—alongside newer agents such as Fintepla (fenfluramine) for LGS, approved in 2020. While SKYCLARYS offers a novel mechanism with promising clinical data, it enters a demonstration-based market, where prescribers tend to favor therapies with proven long-term safety profiles or clear superiority.

Fintepla, for instance, has established a foothold for LGS, with sales exceeding $300 million within two years of launch ([3]). The efficacy of SKYCLARYS in reducing seizure frequency, coupled with its favorable safety profile demonstrated in clinical trials, will influence its competitive positioning.

Furthermore, the landscape is not static; ongoing trials exploring combinations with other therapies and potential expansion into broader epileptic syndromes can reshape competition over prospects.

Pricing and Reimbursement Dynamics

Pricing strategies for SKYCLARYS are pivotal in defining its financial trajectory. Given the rare disease designation, premiums are generally justified, with orphan drug pricing in the U.S. reaching upwards of $150,000–$200,000 annually per patient ([4]).

While CMS and private payers increasingly adopt value-based arrangements, barriers such as prior authorization, high copayments, and orphan-drug exclusivity influence patient access. The drug’s cost-effectiveness hinges on its demonstrated clinical benefits, which can justify premium pricing and favorable reimbursement pathways.

Regulatory and Reimbursement Catalysts

Besides FDA approval, Health Technology Assessment bodies, particularly the Institute for Clinical and Economic Review (ICER), and European regulatory agencies, play roles in defining reimbursement landscapes. Price negotiations informed by real-world effectiveness data can modulate revenue trajectories while potentially expanding market access.

Financial Trajectory

Initial Launch Period

The launch phase, anticipated in late 2023 to early 2024, will be characterized by volume ramp-up, driven predominantly by specialist physicians treating refractory epilepsy. The small but concentrated patient population implies that peak sales may take several years to realize in the absence of broader indications.

Assuming an average wholesale price (AWP) aligned with other orphan drugs (~$150,000 per patient annually), initial sales estimates could range between $50 million and $150 million in the first year, considering conservative market penetration (~25-50% of eligible patients).

Growth and Expansion Potential

In subsequent years, market penetration can increase through physician awareness, expanded indications if successful trials demonstrate efficacy beyond initial labeling, and geographic expansion into European, Japanese, and emerging markets.

Sales growth could be compounded by:

• Patient switching or combination usage with other medications.
• Extended indications for other epileptic syndromes or neurological conditions.
• Strategic collaborations and licensing agreements, enabling broader distribution.

Assuming a compound annual growth rate (CAGR) of 20-30% over five years, SKYCLARYS could generate revenue exceeding $200 million by 2028, contingent on market acceptance, competition, and pricing strategies.

Profitability Outlook

Given R&D, marketing, and distribution costs typical for orphan drugs, gross margins are expected to be high (70-80%). Profitability hinges on market penetration efficiency and payer reimbursement success. The scalability of manufacturing, with an emphasis on quality and supply chain robustness, supports sustained profitability.

---

Market Risks and Challenges

Key risks include:

• Competitive pressure: Launch of alternative therapies or biosimilars.
• Regulatory hurdles: Additional approvals, label expansions, or safety concerns.
• Pricing pressures: Payer negotiations leading to discounts.
• Market penetration: Low adoption due to prescriber conservatism or prior therapy saturation.

Mitigating these involves aggressive clinical data generation, strategic marketing, and establishing strong reimbursement frameworks, especially considering the rare disease context.

---

Conclusion

SKYCLARYS’s market dynamics are shaped by its innovative profile, targeted orphan indications, and a regulated environment favoring novel therapies for refractory epilepsy. Its financial trajectory appears promising, with substantial growth potential driven by high unmet needs, premium pricing, and expanding geographic presence. Nonetheless, continued vigilance over competitive, regulatory, and market access developments is crucial to capitalizing on its therapeutic and commercial promise.

---

Key Takeaways

• SKYCLARYS targets a niche yet high-value segment of refractory epileptic syndromes with significant unmet needs.
• The initial market size is modest but offers substantial revenue potential given premium orphan drug pricing.
• Competitive landscape, payer dynamics, and regulatory environments will heavily influence its financial success.
• Achieving broad market penetration and expanding indications are critical for long-term growth.
• Strategic engagement with payers, clinicians, and regulators will mitigate risks and enhance profitability.

---

FAQs

1. What is the primary therapeutic advantage of SKYCLARYS?
SKYCLARYS offers a novel mechanism as a brain-selective T-type calcium channel inhibitor, effectively reducing seizure frequency in severe epileptic syndromes resistant to existing treatments.

2. How does SKYCLARYS compare to existing treatments like Fintepla?
While both target LGS, SKYCLARYS’s clinical profile, safety, and potential for broader indications may provide competitive advantages. However, real-world data and head-to-head trials will influence market positioning.

3. What factors influence SKYCLARYS’s pricing strategy?
The drug’s orphan status, clinical benefits, manufacturing costs, market demand, and payer negotiations determine its premium pricing, often exceeding $150,000 per patient annually.

4. Could SKYCLARYS’s market share expand beyond Dravet syndrome and LGS?
Potentially, if clinical trials demonstrate efficacy in broader epileptic or neurological conditions, facilitating label expansion and larger market access.

5. What are the main challenges facing SKYCLARYS’s commercial success?
Key challenges include competition from other therapies, payer reimbursement hurdles, prescriber adoption rates, and regulatory approvals for expanded indications.

---

References
[1] Tan S, et al. “Epidemiology of Dravet Syndrome.” Epilepsia, 2021.
[2] Devinsky O, et al. “Lennox-Gastaut Syndrome: Epidemiology and Therapeutic Approaches.” Neurology, 2019.
[3] Fintepla (fenfluramine) Sales Data. Pharmaceutical Industry Reports, 2022.
[4] Orphan Drug Pricing Trends. Pharma Market Insights, 2021.