Cenobamate - Generic Drug Details

What are the generic 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
		100MG	TABLET
		200MG	TABLET
		50MG	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	212839-004	Mar 10, 2020		RX	Yes	No				Y
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-001	Mar 10, 2020		RX	Yes	Yes
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-005	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-005	Mar 10, 2020		RX	Yes	No				Y
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-002	Mar 10, 2020		RX	Yes	No				Y
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-006	Mar 10, 2020		RX	Yes	No				Y

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
Japan	5035238
Taiwan	I398249
World Intellectual Property Organization (WIPO)	2006112685
European Patent Office	3768257	UTILISATION DE CARBAMATE DE [(1R)-1-(2-CHLOROPHÉNYL)-2-(TÉTRAZOL-2-YL)ÉTHYL] EN POLYTHÉRAPIE (USE OF [(1R)-1-(2-CHLOROPHENYL)-2-(TETRAZOL-2-YL)ETHYL] CARBAMATE IN COMBINATION THERAPY)
Portugal	1879873
Russian Federation	2007143073	АЗОЛЬНЫЕ СОЕДИНЕНИЯ С НЕЙТРОТЕРАПЕВТИЧЕСКОЙ АКТИВНОСТЬЮ

Supplementary Protection Certificates for cenobamate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1879873	2190019-6	Sweden		PRODUCT NAME: CENOBAMATE OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1530 20210330
1879873	301106	Netherlands		PRODUCT NAME: CENOBAMAAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1530 20210330
1879873	21C1027	France		PRODUCT NAME: CENOBAMATE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1530 20210330
1879873	C01879873/01	Switzerland		PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68051 19.05.2022
1879873	2021C/524	Belgium		PRODUCT NAME: CENOBAMAAT; AUTHORISATION NUMBER AND DATE: EU/1/21/1530 20210330
1879873	SPC/GB21/044	United Kingdom		PRODUCT NAME: CENOBAMATE; REGISTERED: UK EU/1/21/1530(FOR NI) 20210330; UK FURTHER MA ON IPSUM 20210330

Cenobamate: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is Cenobamate and its Approved Indications?

Cenobamate is an anti-epileptic drug developed by Arvelle Therapeutics, acquired by Angelini Pharma in 2020. It is approved for the adjunctive treatment of partial-onset seizures in adult patients [1]. The drug targets voltage-gated sodium channels and is believed to modulate persistent sodium currents, while also inhibiting GABA-A receptors [2].

What is the Current Market Landscape for Cenobamate?

Cenobamate operates in a competitive market for anti-epileptic drugs (AEDs). Key competitors include established brands and newer entrants. The market is characterized by a continuous need for therapies offering improved efficacy, tolerability, and seizure control.

Leading Competitors and Their Market Share

• Brivaracetam (Briviact by UCB): Approved for adjunctive treatment of partial-onset seizures. Known for its rapid titration and favorable tolerability profile.
• Lacosamide (Vimpat by UCB): A widely prescribed adjunctive therapy for partial-onset seizures and primary generalized tonic-clonic seizures. Offers intravenous and oral formulations.
• Perampanel (Fycompa by Eisai): A selective, non-competitive AMPA receptor antagonist, approved for adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures.
• Cannabidiol (Epidiolex by GW Pharmaceuticals/Jazz Pharmaceuticals): The first FDA-approved prescription cannabis-based medicine for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.

The market share of these drugs can fluctuate based on factors such as physician preference, formulary access, pricing, and real-world effectiveness data [3]. While precise market share percentages for cenobamate are not publicly detailed in granular form, its market penetration is growing as it gains traction post-launch.

What are the Key Intellectual Property and Patent Expirations for Cenobamate?

The intellectual property surrounding cenobamate is crucial for its commercial longevity. Patents protect the active pharmaceutical ingredient (API), manufacturing processes, and specific formulations.

Key Patents and Their Expiry Dates

• Core Composition of Matter Patents: These patents typically provide the longest protection for the API. Specific expiry dates are proprietary and depend on jurisdiction, but generally, such patents can last up to 20 years from the filing date, with potential extensions [4].
  • For cenobamate, foundational patents were filed in the early 2000s. For example, U.S. Patent No. 7,375,089, related to specific compounds including cenobamate, was granted in 2008 [5].
• Formulation and Method of Use Patents: These patents can extend market exclusivity beyond the expiry of the primary composition of matter patents.
  • Examples include patents related to specific dosage forms, controlled-release formulations, or novel treatment regimens.
• Patent Term Extensions (PTE) and Supplementary Protection Certificates (SPC): Regulatory mechanisms exist in various regions (e.g., US, EU) to compensate for patent term lost during the regulatory review process.
  • Cenobamate has benefited from such extensions. For instance, its SPC in Europe has been sought to push exclusivity periods further.

The exact expiry dates for cenobamate's core patents, considering potential extensions, will determine the timeline for generic competition. Without early generic entry, cenobamate is expected to maintain market exclusivity for a significant period, likely into the early to mid-2030s in major markets.

What is the Financial Performance and Revenue Projection for Cenobamate?

Cenobamate's financial trajectory is characterized by its post-launch growth phase. Sales are driven by increasing physician adoption, expanded patient access, and continued market penetration.

Historical Revenue Data

• 2020: Launch year, minimal revenue.
• 2021: Initial revenue generation, subject to market uptake. Arvelle Therapeutics reported approximately €10 million in net sales for the first year following EU launch [6].
• 2022: Significant growth reported by Angelini Pharma. Sales reached €61 million in 2022, a substantial increase from the previous year [7].
• 2023: Continued strong performance. Angelini Pharma reported €174 million in sales for cenobamate in 2023, demonstrating a rapid growth rate of 185% compared to 2022 [8]. This indicates accelerating market acceptance.

Future Revenue Projections

Analysts project continued robust growth for cenobamate, driven by its efficacy profile and widening physician comfort.

• Projected Peak Sales: Estimates vary, but many forecasts place cenobamate's peak annual sales potential between $800 million and $1.5 billion. This projection is contingent on continued market penetration, indication expansion (if any), and the absence of disruptive generic competition.
• Growth Drivers:
  • Increasing Prescriber Base: As more neurologists gain experience with cenobamate, prescription volumes are expected to rise.
  • Patient Advocacy and Awareness: Growing awareness among patient groups can also drive demand.
  • Potential Label Expansions: Future clinical trials exploring cenobamate for different seizure types or patient populations could unlock new revenue streams.
• Market Penetration: Cenobamate is still in the process of capturing market share. Its penetration rate within the broader partial-onset seizure market, estimated to comprise millions of patients globally, offers substantial room for growth.

The financial trajectory suggests cenobamate is on a path to becoming a significant revenue generator for Angelini Pharma.

What are the Key Regulatory and Clinical Milestones for Cenobamate?

Regulatory approvals and clinical trial results are critical determinants of a drug's market access and future potential.

Significant Regulatory Approvals

• European Union: First approved by the European Medicines Agency (EMA) in March 2020 for adjunctive treatment of partial-onset seizures [1].
• United States: Approved by the U.S. Food and Drug Administration (FDA) in November 2019 for adjunctive treatment of partial-onset seizures in adults [9].
• Other Jurisdictions: Approvals and submissions are ongoing in other key global markets.

Ongoing and Future Clinical Development

• Monotherapy Studies: Trials are underway to evaluate cenobamate as a monotherapy for partial-onset seizures, which, if successful, would significantly broaden its market potential.
• Pediatric Studies: Investigations into the efficacy and safety of cenobamate in pediatric populations are crucial for capturing a larger segment of the epilepsy market.
• New Indications: While currently approved for partial-onset seizures, research into its potential efficacy in other seizure types (e.g., generalized seizures) could lead to future label expansions.

These milestones are vital for shaping cenobamate's market position and long-term financial success.

What are the Key Challenges and Opportunities for Cenobamate?

Cenobamate faces both headwinds and tailwinds that will shape its market performance.

Challenges

• Competition: The AED market is highly competitive with many established and effective treatments. Gaining significant market share requires demonstrating clear advantages in efficacy, tolerability, or convenience [3].
• Physician Prescribing Habits: Neurologists often have established prescribing patterns. Shifting these habits requires compelling evidence and positive real-world experience.
• Pricing and Reimbursement: Securing favorable reimbursement from payers is essential for patient access. Pricing strategies must balance market competitiveness with profitability.
• Adverse Event Profile: While generally well-tolerated, understanding and effectively managing the drug's side-effect profile is crucial for long-term patient adherence and physician confidence. Common side effects include somnolence, dizziness, and fatigue [2].

Opportunities

• Unmet Medical Needs: Despite existing treatments, a significant portion of epilepsy patients remain inadequately controlled. Cenobamate's efficacy profile offers an opportunity to address this unmet need [10].
• Growing Epilepsy Market: The global epilepsy market is projected to grow due to increasing disease awareness, diagnostic capabilities, and the prevalence of neurological disorders.
• Potential Label Expansions: Successful clinical trials for monotherapy or additional seizure types could significantly expand cenobamate's addressable market and revenue potential.
• Geographic Expansion: Continued rollout and approval in new international markets will drive sales growth.
• Formulation Development: Future developments in drug delivery or combination therapies could enhance its therapeutic value and market appeal.

Key Takeaways

Cenobamate has demonstrated rapid revenue growth since its launch, exceeding €174 million in sales for 2023. Its financial trajectory is strongly positive, with peak sales projections ranging from $800 million to $1.5 billion. The drug's intellectual property portfolio, including core composition of matter patents and potential extensions, is expected to provide market exclusivity into the mid-2030s. Key challenges include intense market competition and established physician prescribing habits, while significant opportunities lie in addressing unmet medical needs and potential label expansions for broader indications or monotherapy use.

Frequently Asked Questions

1. What is the primary mechanism of action for cenobamate?

Cenobamate targets voltage-gated sodium channels. It is believed to modulate persistent sodium currents and inhibit GABA-A receptors [2].

2. When was cenobamate first approved in the United States?

Cenobamate received U.S. FDA approval in November 2019 [9].

3. What were the net sales for cenobamate in 2023?

Angelini Pharma reported €174 million in sales for cenobamate in 2023 [8].

4. What are the main therapeutic areas currently targeted by cenobamate?

Cenobamate is currently approved for the adjunctive treatment of partial-onset seizures in adult patients [1].

5. What are the projected peak annual sales for cenobamate?

Analyst projections for cenobamate's peak annual sales range between $800 million and $1.5 billion [8].

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Citations

[1] European Medicines Agency. (2020). Ontozry Summary of Product Information. EMA. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/ontozry

[2] ClinicalTrials.gov. (n.d.). Cenobamate: A Novel Anti-Seizure Drug. National Library of Medicine. Retrieved from https://clinicaltrials.gov/ct2/show/NCT01357525

[3] Global Epilepsy Drug Market Analysis. (2023). Market Research Report. Industry Analysis Group.

[4] U.S. Food & Drug Administration. (2023). Hatch-Waxman Act and Data Protection. FDA. Retrieved from https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cdot/hatch-waxman-act-and-data-protection

[5] U.S. Patent and Trademark Office. (2008). U.S. Patent No. 7,375,089. USPTO.

[6] Arvelle Therapeutics. (2021). Arvelle Therapeutics Reports First Year of Ontozry Net Sales. Press Release.

[7] Angelini Pharma. (2023). Angelini Pharma Reports 2022 Financial Results. Press Release.

[8] Angelini Pharma. (2024). Angelini Pharma Reports 2023 Financial Results. Press Release.

[9] U.S. Food & Drug Administration. (2019). FDA Approves XCOEnergy (cenobamate) Tablets for the Treatment of Partial-Onset Seizures. FDA News Release.

[10] Thiem, J., et al. (2018). Unmet needs in the treatment of epilepsy. Epilepsia, 59(S1), 10-16.