CENOBAMATE - Generic Drug Details

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

Cenobamate is the generic ingredient in one branded drug marketed by Sk Life and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cenobamate has twenty-six patent family members in twenty countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for CENOBAMATE

International Patents:	26
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	15
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CENOBAMATE
What excipients (inactive ingredients) are in CENOBAMATE?	CENOBAMATE excipients list
DailyMed Link:	CENOBAMATE at DailyMed

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

Dosage:

TABLET;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 CENOBAMATE

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

Sponsor	Phase
SK Life Science, Inc.	PHASE4
Brigham and Women's Hospital	EARLY_PHASE1
Ono Pharmaceutical Co. Ltd	PHASE2

See all CENOBAMATE clinical trials

Generic filers with tentative approvals for CENOBAMATE

Applicant	Application No.	Strength	Dosage Form
		12.5MG	TABLET
		25MG	TABLET
		100MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CENOBAMATE

Mechanism of Action

Cytochrome P450 2B6 Inducers Cytochrome P450 2B6 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inducers Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inducers GABA A Receptor Positive Modulators Sodium Channel Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for CENOBAMATE

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for CENOBAMATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XCOPRI	Tablets	cenobamate	12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg	212839	2	2024-03-11

US Patents and Regulatory Information for CENOBAMATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-002	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-001	Mar 10, 2020		RX	Yes	Yes				Y
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-003	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-001	Mar 10, 2020		RX	Yes	Yes

EU/EMA Drug Approvals for CENOBAMATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Angelini Pharma S.p.A	Ontozry	cenobamate	EMEA/H/C/005377Adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.	Authorised	no	no	no	2021-03-26

International Patents for CENOBAMATE

Country	Patent Number	Title	Estimated Expiration
South Korea	20080005437	NEUROTHERAPEUTIC AZOLE COMPOUNDS
World Intellectual Property Organization (WIPO)	2006112685
Poland	1879873
World Intellectual Property Organization (WIPO)	2019182376

Supplementary Protection Certificates for CENOBAMATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1879873	C202130027	Spain		PRODUCT NAME: CENOBAMATO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1530; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1530; DATE OF FIRST AUTHORISATION IN EEA: 20210326
1879873	122021000027	Germany		PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: EU/1/21/1530 20210326
1879873	21C1027	France		PRODUCT NAME: CENOBAMATE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1530 20210330
1879873	CA 2021 00015	Denmark		PRODUCT NAME: CENOBAMAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1530 20210330

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Cenobamate

Last updated: July 27, 2025

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Introduction

Cenobamate (marketed as YKP3089) is a novel antiepileptic drug (AED) approved by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of partial-onset seizures in adults. As an emerging player in the neurological therapeutics space, cenobamate’s market potential is driven by the increasing prevalence of epilepsy worldwide, advances in pharmacological profiles, and strategic positioning by pharmaceutical firms. This analysis examines the evolving market landscape, competitive dynamics, regulatory factors, and financial forecasts shaping cenobamate’s trajectory.

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Market Landscape and Epidemiological Factors

The global epilepsy market was valued at approximately USD 4.0 billion in 2021 and is projected to reach USD 5.6 billion by 2028, growing at a compound annual growth rate (CAGR) of 4.8%[1]. The rise is attributable to the increasing incidence of epilepsy—estimated at about 50 million affected individuals globally—along with improved awareness and diagnostic capabilities.

Partial-onset seizures, which constitute roughly 60-70% of epilepsy cases, are the primary target for cenobamate. Notably, treatment-resistant epilepsy cases often require adjunctive therapies, increasing demand for drugs with enhanced efficacy profiles (e.g., lesser cognitive impairment, fewer side effects) such as cenobamate offers.

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Competitive Landscape and Market Positioning

Existing Therapies
Cenobamate faces competition from established AEDs like carbamazepine, levetiracetam, lamotrigine, and newer drugs such as cannabidiol (Epidiolex) and eslicarbazepine. The landscape is characterized by a mix of first-generation medications with broad-spectrum activity and newer, more targeted agents.

Unique Selling Proposition of Cenobamate
Cenobamate’s mechanism involves modulation of voltage-gated sodium channels and positive allosteric modulation of GABA_A receptors, contributing to its dual action on seizure prevention. Clinical trials demonstrated a significant reduction in seizure frequency (up to 55%) and a favorable tolerability profile[2]. Its rapid onset and lower cognitive side effects enhance its appeal for both clinicians and patients.

Market Penetration Strategies
Pharmaceutical companies are leveraging data from pivotal trials to position cenobamate as a high-efficacy alternative, especially for refractory cases. Post-approval, expanding formal indications (e.g., generalized seizures) and integrating into formulary lists will be critical to capturing market share.

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Regulatory and Reimbursement Environment

Regulatory Approvals
Beyond FDA approval, cenobamate has secured marketing authorization in multiple jurisdictions, including Europe (EMA approval in 2020), solidifying its global footprint. Regulatory agencies emphasize its safety profile, with warnings related to hypersensitivity reactions and somnolence, mandating provider training standards.

Reimbursement and Pricing Strategies
Pricing for cenobamate is positioned at a premium relative to older AEDs, justified by its clinical benefits. Payor negotiations focus on demonstrating cost-effectiveness through reduced seizure-related hospitalizations and improved quality of life metrics.

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Financial Trajectory and Revenue Forecast

Initial Market Entry and Adoption
Since its launch in 2020, cenobamate’s initial revenue generation was modest but grew steadily as awareness increased among neurologists. Early adoption was driven by clinical data and physician familiarity with managing resistant epilepsy.

Projected Revenue Growth
Market analysts forecast a compound annual growth rate (CAGR) of approximately 12-15% over the next five years, driven by:

• Expanding approved indications, including generalized seizures.
• Geographic expansion into emergent markets like Asia-Pacific and Latin America.
• Increasing reimbursement coverage and formulary inclusion.
• Pharmacoeconomic studies supporting cost-benefit advantages.

Revenue Breakdown (2022-2027)

• 2022: USD 150 million – initial post-launch revenues.
• 2023-2024: USD 300–500 million – increased adoption, expanded prescriber base.
• 2025-2027: USD 600–900 million – peak penetration in primary markets, regional expansion, and ongoing clinical endorsement.

Pricing and Market Share Estimations
High efficacy and reduced side effects enable premium pricing (~USD 10,000–USD 15,000/year per patient). As the drug captures 20-25% of the partial-onset seizure market segment, revenue growth will be partly capped by treatment penetration rates and competing therapies’ evolution.

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Market Challenges and Risks

Safety Concerns
Adverse effects such as sedation, dizziness, and rare hypersensitivity reactions may hinder broader adoption. Continuous pharmacovigilance is necessary to sustain confidence and market acceptability.

Competitive Innovation
Emergence of gene therapies, neuromodulation devices, and other novel AEDs could impact cenobamate’s share. It must evolve clinically and strategically to maintain relevance.

Regulatory and Reimbursement Barriers
Stringent approval processes and complex reimbursement negotiations in emerging markets may slow adoption, temper growth estimates.

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Growth Opportunities and Strategic Outlook

Broadening Indications
Approvals for generalized seizures or other neurological conditions could significantly expand revenue streams.

Combination Therapies
Synergistic use with other AEDs could optimize seizure control, enlarging the patient population eligible for cenobamate.

Biopharmaceutical Alliances
Partnerships for research, licensing, or co-marketing can accelerate adoption and regional expansion.

Digital and Monitoring Solutions
Integration with digital health tools for seizure tracking enhances patient management and supports sales efforts.

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Key Takeaways

• Cenobamate is poised for significant growth in the global antiepileptic market, driven by its clinical efficacy and safety profile.
• Revenue forecasts indicate a compound annual growth rate of approximately 12-15% over the next five years, with peak revenues approaching USD 900 million annually domestically and in key international markets.
• Market success hinges on expanding indications, optimizing pricing, and overcoming safety concerns and competitive challenges.
• The drug’s differentiated mechanism of action and strategic positioning will be critical assets in capturing market share within a competitive therapeutic landscape.
• Ongoing pharmacoeconomic validation, reimbursement negotiations, and clinical adoption will determine long-term profitability.

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FAQs

1. What is the primary indication for cenobamate?
Cenobamate is approved for adjunctive treatment of partial-onset seizures in adults with epilepsy.

2. How does cenobamate compare to existing AEDs?
It offers a higher seizure reduction rate with a favorable side effect profile, especially in treatment-resistant cases, enhancing its competitive edge.

3. What are the key regulatory considerations for cenobamate?
Approval delays or restrictions due to safety concerns could impact market penetration; ongoing pharmacovigilance is vital.

4. What is the global market outlook for cenobamate?
Expanding approvals and increasing awareness suggest a positive trajectory, with significant growth potential in emerging markets.

5. What are the main challenges facing cenobamate’s commercial success?
Competition, safety management, reimbursement hurdles, and potential regulatory limitations are primary risk factors.

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References

[1] Grand View Research. Epilepsy Therapeutics Market Size & Trends. 2022.
[2] French JA, et al. Lancet Neurology, 2019; 18(4): 402–410.