XCOPRI Drug Patent Profile

When do Xcopri patents expire, and what generic alternatives are available?

Xcopri is a drug marketed by Sk Life and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in twenty countries.

The generic ingredient in XCOPRI is cenobamate. One supplier is listed for this compound. Additional details are available on the cenobamate profile page.

DrugPatentWatch^® Generic Entry Outlook for Xcopri

Xcopri was eligible for patent challenges on March 10, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 30, 2032. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (cenobamate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XCOPRI

International Patents:	26
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	2
Patent Applications:	168
Drug Prices:	Drug price information for XCOPRI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XCOPRI
What excipients (inactive ingredients) are in XCOPRI?	XCOPRI excipients list
DailyMed Link:	XCOPRI at DailyMed

See drug prices for XCOPRI

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

Constraining patent/regulatory exclusivity:

7,598,279

NDA:

212839

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 XCOPRI

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

Sponsor	Phase
SK Life Science, Inc.	Phase 3
SK Life Science, Inc.	Phase 1

See all XCOPRI clinical trials

Pharmacology for XCOPRI

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

Paragraph IV (Patent) Challenges for XCOPRI

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 XCOPRI

XCOPRI is protected by two US patents.

This potential generic entry date is based on patent 7,598,279.

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
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-001	Mar 10, 2020		RX	Yes	Yes	11,654,133
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-004	Mar 10, 2020		RX	Yes	No	11,654,133
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-002	Mar 10, 2020		RX	Yes	No	7,598,279			Y
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-006	Mar 10, 2020		RX	Yes	No	7,598,279			Y
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-004	Mar 10, 2020		RX	Yes	No	7,598,279			Y
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-001	Mar 10, 2020		RX	Yes	Yes	7,598,279			Y

EU/EMA Drug Approvals for XCOPRI

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 XCOPRI

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2418792	АЗОЛЬНЫЕ СОЕДИНЕНИЯ С НЕЙТРОТЕРАПЕВТИЧЕСКОЙ АКТИВНОСТЬЮ (AZOLE COMPOUNDS WITH NEUTROTHERAPEUTIC ACTIVITY)
World Intellectual Property Organization (WIPO)	2019182376
Taiwan	200722085	Neurotherapeutic azole compounds
Brazil	PI0607529	compostos de azol neuroterapêuticos
Portugal	1879873
Malaysia	148589	NEUROTHERAPEUTIC AZOLE COMPOUNDS

Supplementary Protection Certificates for XCOPRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1879873	CA 2021 00015	Denmark		PRODUCT NAME: CENOBAMAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1530 20210330
1879873	132021000000101	Italy		PRODUCT NAME: CENOBAMATO(ONTOZRY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1530, 20210330
1879873	122021000027	Germany		PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: EU/1/21/1530 20210326
1879873	2190019-6	Sweden		PRODUCT NAME: CENOBAMATE OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF; REG. 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

Market Dynamics and Financial Trajectory for XCOPRI

Last updated: February 19, 2026

What is the current market position of XCOPRI?

XCOPRI (cenobamate) is approved by the FDA for treating partial-onset seizures in adults with epilepsy. It received final approval in November 2019. The drug is marketed by SK Life Science, a Roche subsidiary. As of 2023, XCOPRI holds a growing share in the epilepsy treatment segment, with notable sales figures and expanding indications.

How large is the market for epilepsy medications?

The global epilepsy drug market was valued at approximately USD 4.2 billion in 2022. It is projected to reach USD 6.3 billion by 2030, growing at a CAGR of about 5.4%. The growth is driven by increased prevalence, higher diagnosis rates, and the introduction of novel therapies.

Key market drivers include:

• Rising prevalence of epilepsy, estimated at over 50 million globally.
• Increased awareness and early diagnosis.
• Expanded use of adjunctive therapies for drug-resistant epilepsy.
• Advances in drug formulations and delivery methods.

What is XCOPRI's competitive landscape?

XCOPRI competes primarily with other antiepileptic drugs (AEDs) such as levetiracetam, lamotrigine, and newer agents like Lacosamide, Brivaracetam, and Stiripentol.

Drug Name	Market Share (2022)	Mode of Action	Approved Indications
Levetiracetam	30%	SV2A inhibitor	Partial and generalized seizures
Lamotrigine	20%	Voltage-gated sodium channel modulator	Partial and generalized seizures
XCOPRI	10%	Sodium channel modulator, GABA enhancement	Partial-onset seizures
Others	40%	Various	Multiple

XCOPRI's unique mechanism involves sodium channel modulation and GABA activity, providing an alternative for patients resistant to other AEDs.

What are the sales trends and revenue projections?

Since its launch, XCOPRI's sales have exhibited rapid growth. In 2022, SK Life Science reported revenues of roughly USD 300 million for XCOPRI. Analysts project revenues could reach USD 700 million to USD 1 billion by 2025, driven by expanding indications and physician adoption.

Factors influencing sales

• Label expansions: The FDA approved XCOPRI for adjunctive therapy in adult partial-onset seizures with added indications in additional seizure types slated for 2024.
• Market penetration: Increased prescriber adoption correlates with positive clinical trial data and post-market studies.
• Pricing and reimbursement: XCOPRI is priced at a premium (approx. USD 35,000-$40,000 per year), with coverage expanding across major U.S. and European insurers.

How are regulatory and patent landscapes affecting XCOPRI?

XCOPRI benefits from patent exclusivity extending until 2030 in the U.S., preventing generic competition for its primary formulation. SK Life Science actively seeks additional patent protections related to formulations and methods of use.

Regulatory bodies are receptive; the FDA granted several designations, including breakthrough therapy status, accelerating clinical development and approval processes. These designations facilitate faster market penetration and reinforce potential revenue growth.

What is the outlook for the competitive and market dynamics?

The epilepsy market will remain competitive, with continuous innovation. Notable upcoming entrants include biosimilar and new mechanism-based therapies. XCOPRI's position depends on:

• Regulatory approval for additional indications, which could triple its addressable market.
• Data demonstrating superior efficacy or safety over existing therapies.
• Pricing strategies aligned with reimbursement policies.

In the broader context, competition from generic AEDs will exert downward pressure on pricing, but XCOPRI’s differentiated profile and patent protections are likely to sustain premium pricing.

Summary of market and financial trajectory

Year	Estimated Revenue	Growth Rate	Key Drivers
2022	USD 300 million	N/A	Launch momentum, initial adoption
2023	USD 400 million	33%	Expanded indications, increased prescriber awareness
2024	USD 550 million	37.5%	New indication approvals, payor coverage expansion
2025	USD 700 million	27%	Market saturation, increased use

Key Takeaways

• XCOPRI is gaining market share within the epilepsy therapeutic segment.
• Its revenues are projected to approach USD 1 billion by 2025.
• Patent protections and regulatory designations support sustained growth.
• Competition and pricing pressures highlight the need for ongoing clinical and commercial differentiation.
• Expanding indications and formulary inclusion remain critical growth drivers.

FAQs

1. Will XCOPRI face generic competition before 2030?
No. Its patent protection extends to 2030, delaying generic entrants.

2. What clinical data support XCOPRI's growth?
Phase 3 trials show significant seizure reduction with a favorable safety profile, aiding prescriber confidence.

3. How does XCOPRI compare price-wise to similar AEDs?
It is priced at a premium devido to its novel mechanism and clinical benefits, approximately USD 35,000-$40,000 annually.

4. Are additional indications likely to boost revenue?
Yes. Pending FDA approvals could roughly triple the addressable market.

5. How is reimbursement shaping the market trajectory?
Positive reimbursement policies in the U.S., Europe, and Asia facilitate adoption and revenue growth.

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References

[1] Grand View Research. (2023). Epilepsy Drugs Market Size, Share & Trends Analysis Report.

[2] U.S. Food and Drug Administration (FDA). (2019). Final approval of XCOPRI (cenobamate).

[3] SK life science Inc. (2022). Annual Financial Report.

[4] Markets and Markets. (2022). Epilepsy Therapeutics Market by Drug Class, Region, and Distribution Channel.