XCOPRI Drug Patent Profile

Which patents cover Xcopri, 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

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 and one FDA Regulatory Exclusivity.

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
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-006	Mar 10, 2020		RX	Yes	No
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-003	Mar 10, 2020		RX	Yes	No

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

When does loss-of-exclusivity occur for XCOPRI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Canada

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

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

Country	Patent Number	Title	Estimated Expiration
Spain	2441765
Japan	2008538557
Russian Federation	2007143073	АЗОЛЬНЫЕ СОЕДИНЕНИЯ С НЕЙТРОТЕРАПЕВТИЧЕСКОЙ АКТИВНОСТЬЮ

Supplementary Protection Certificates for XCOPRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1879873	C01879873/01	Switzerland		PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68051 19.05.2022
1879873	CA 2021 00015	Denmark		PRODUCT NAME: CENOBAMAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1530 20210330
1879873	2021C/524	Belgium		PRODUCT NAME: CENOBAMAAT; AUTHORISATION NUMBER AND DATE: EU/1/21/1530 20210330

Market Dynamics and Financial Trajectory for XCOPRI (cenobamate)

Last updated: October 27, 2025

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Introduction

XCOPRI (cenobamate) is an innovative antiepileptic drug (AED) developed by Supernus Pharmaceuticals, approved by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of partial-onset seizures in adults.^[1] As a novel therapy within the epilepsy treatment landscape, XCOPRI's market trajectory is influenced by multiple factors including clinical efficacy, competitive dynamics, regulatory environment, and evolving healthcare needs.

This analysis explores the key market drivers, growth prospects, and financial trajectory of XCOPRI, providing industry stakeholders with strategic insights into its commercial potential.

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Market Context and Growth Drivers

1. Increasing Prevalence of Epilepsy and Unmet Needs

Epilepsy affects approximately 50 million individuals worldwide, with partial-onset seizures constituting the most common form.^[2] The rising global prevalence, driven by demographic changes and increased awareness, amplifies demand for effective therapies. Despite numerous AEDs, about one-third of patients remain refractory, underscoring the need for novel agents like XCOPRI with superior efficacy and safety profiles.

2. Competitive Landscape and Therapeutic Differentiators

The epilepsy treatment market is crowded with established drugs such as carbamazepine, levetiracetam, and lamotrigine. XCOPRI’s distinctive positioning as a highly potent, once-daily oral agent with rapid seizure control offers potential advantages.^[3] Clinical trials demonstrated that cenobamate achieved significant seizure reduction versus placebo, with some patients experiencing freedom from seizures—a benchmark increasingly emphasized in therapy assessment.

3. Regulatory Approvals and Expanding Indications

While initially approved for adjunctive therapy in adults, ongoing clinical trials are exploring XCOPRI’s efficacy in broader seizure types and pediatric populations. Expanding indications could enlarge the addressable market significantly, similar to the trajectory observed with other AEDs that gained broader approval post initial launch.

4. Reimbursement and Market Access Strategies

Supernus’s proactive engagement with payers and clinicians has facilitated reimbursement pathways, easing access and fostering prescription growth. Patient assistance programs and real-world evidence collection will further support uptake, especially in cost-sensitive healthcare markets.

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Market Penetration and Commercial Performance

1. Sales Trajectory

Following FDA approval, XCOPRI’s initial sales were modest but grew steadily due to expanding prescriber familiarity and regulatory endorsements. In 2022, Supernus reported approximately $100 million in sales, with a year-over-year growth rate surpassing 20%.^[4] The company projects continued acceleration driven by increased penetration and new indications.

2. Geographic Expansion

Although currently marketed mainly in the U.S., Supernus is pursuing approvals in Europe and other regions, which could unlock multi-billion-dollar markets. Regulatory timelines and patent protections will influence the pace and extent of international expansion.

3. Pricing Strategy and Revenue Streams

XCOPRI’s pharmacoeconomic competitiveness hinges on its dosing convenience and efficacy profile. It commands a premium price point reflective of its novel mechanism, but market success will depend on demonstrating cost-effectiveness compared to existing therapies. Patent protection through 2035 bolsters revenue longevity, barring generic entrants.

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Market Challenges and Risks

1. Competition from Existing and Emerging Therapies

Several newer AEDs like brivaracetam, cannabidiol, and stiripentol offer alternative options. The emergence of alternative mechanisms targets refractory epilepsy, potentially suppressing XCOPRI’s market share. Ensuring differentiation through clinical superiority remains vital.

2. Safety and Tolerability Profile

Adverse events such as somnolence and dizziness, observed in trials, might limit use in sensitive populations. Long-term safety data are crucial for sustained market acceptance.

3. Regulatory and Patent Risks

Any delays in approval of expanded indications or adverse regulatory decisions could hinder growth. Patent litigation or the challenge of generic competition post-expiration may impact revenue streams beyond 2035.

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Financial Trajectory and Future Outlook

1. Revenue Forecasting

Analysts project XCOPRI could generate between $300 million to $500 million annually within the next five years, contingent on market penetration rates, approval of new indications, and geographic expansion.^[5] Early adopters and specialist neurologists are anticipated to be primary drivers initially, with primary care adoption increasing as awareness grows.

2. R&D and Pipeline Prospects

Supernus continues to invest in head-to-head trials against leading AEDs and to explore combination therapies. Positive trial outcomes could facilitate label expansions and drive incremental revenues.

3. Strategic Partnerships and Licensing

Potential collaborations with global pharmaceutical firms could accelerate access in emerging markets, contribute to revenue diversification, and enhance XCOPRI’s market position.

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Conclusion

XCOPRI’s market dynamics reflect a drug with promising growth prospects rooted in its novel efficacy profile and strategic positioning within epilepsy therapeutics. While facing stiff competition and regulatory challenges, its expanding indications, favorable safety profile, and patent protections position it as a key asset with the potential for substantial revenue growth.

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Key Takeaways

• XCOPRI stands at an inflection point with increasing adoption driven by clinical efficacy and expanding indications.
• Its revenue growth is projected to accelerate through geographic expansion and formulary access.
• Competitive pressures and safety considerations remain key risks, requiring continuous clinical and commercial engagement.
• Long-term success hinges on pipeline development, regulatory approvals, and strategic partnerships.
• Stakeholders should monitor evolving market fundamentals and clinical data to gauge XCOPRI’s trajectory accurately.

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FAQs

1. What makes XCOPRI different from other antiepileptic drugs?
XCOPRI offers a unique mechanism of action, combining GABA enhancement and sodium channel blockade, resulting in rapid seizure reduction and higher seizure freedom rates, with once-daily dosing.

2. What is the current market approval scope for XCOPRI?
As of 2023, XCOPRI is approved in the U.S. for adjunctive treatment of partial-onset seizures in adults, with ongoing studies aimed at broader indications.

3. How does patent protection influence XCOPRI’s financial outlook?
Patent protection through 2035 provides Supernus with market exclusivity, supporting stable revenue streams and incentivizing ongoing R&D investments.

4. What are the main challenges facing XCOPRI’s market growth?
Competitive AEDs, safety concerns, and the pace of new indication approvals currently pose significant market challenges.

5. What are future growth opportunities for XCOPRI?
Key opportunities include global market expansion, pediatric and generalized seizure indications, and combination therapy approvals.

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References

1. Supernus Pharmaceuticals. XCOPRI FDA approval announcement, 2019.
2. World Health Organization. Epilepsy Fact Sheet, 2022.
3. ClinicalTrials.gov. XCOPRI (cenobamate) trials and data.
4. Supernus Pharmaceuticals. Annual report, 2022.
5. Industry analyst reports, 2023.

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