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 are two tentative approvals 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:	153
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
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839-002	Mar 10, 2020		RX	Yes	No	11,654,133

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
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)
World Intellectual Property Organization (WIPO)	2019182376
Argentina	053065	COMPUESTOS AZOLICOS NEUROTERAPEUTICOS Y COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN
Australia	2006237798	Neurotherapeutic azole compounds
Brazil	PI0607529	compostos de azol neuroterapêuticos
Canada	2606258	COMPOSES AZOLE NEUROTHERAPEUTIQUES (NEUROTHERAPEUTIC AZOLE COMPOUNDS)
China	101228138	Neurotherapeutic azole compounds

Supplementary Protection Certificates for XCOPRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1879873	301106	Netherlands		PRODUCT NAME: CENOBAMAAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1530 20210330
1879873	122021000027	Germany		PRODUCT NAME: CENOBAMAT; REGISTRATION NO/DATE: EU/1/21/1530 20210326
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
1879873	19/2021	Austria		PRODUCT NAME: CENOBAMAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1530 (MITTEILUNG) 20210330
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	132021000000101	Italy		PRODUCT NAME: CENOBAMATO(ONTOZRY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1530, 20210330

XCOPRI (cenobamate) market dynamics and financial trajectory: exclusivity path, adoption curves, payor pressure, and revenue outlook

Last updated: July 25, 2026

XCOPRI (cenobamate) is a branded anti-seizure drug targeting partial-onset seizures in adults. The market trajectory since launch is best read through (1) conversion from prior add-on antiseizure regimens, (2) payer step edits and copay controls, (3) neurologist preference for “early” add-on use, and (4) label expansion dynamics and ongoing competitive entry risk.

Core market facts that shape financial outcomes

• Indication: partial-onset (focal) seizures in adults, administered as adjunctive therapy.
• Commercial model: branded sales tied to prescriber onboarding and formulary placement in complex, high-frequency chronic care.
• Differentiation: rapid titration schedules and higher responder rates versus historical add-on baselines in trials. (Market share gains depend on payer coverage and physician comfort with titration and monitoring.)

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What is XCOPRI’s market size and how fast is cenobamate gaining share?

Fast answer: XCOPRI’s growth has depended on neurologist adoption as an add-on for refractory focal seizures, with share expanding fastest in geographies and plans that allow broader “non-preferred” coverage with prior authorization and copay support.

Adoption drivers that map to revenue curves

1. Neurologist prescribing inertia: Long-term epilepsy care relies on add-on sequencing. XCOPRI gained traction where clinicians view it as a tolerability-and-efficacy tradeoff versus older add-ons.
2. Formulary access: Branded anti-seizure drugs in the US often face step edits across commercial plans. XCOPRI’s revenue trajectory tracks payer willingness to cover “after failure of 1–2” alternatives.
3. Switching behavior: Financial performance improves when XCOPRI shifts from “trial add-on” to “second-line add-on” rather than remaining a last-resort option.

Adoption bottlenecks that cap upside

• Prior authorization and step therapy: Delays reduce new starts.
• Titration burden and safety monitoring: XCOPRI requires structured titration; prescribers may avoid use where clinic workflows are not set up.
• Competition from other new antiseizure therapies: Where payers prefer lower-cost generics or newer branded agents with better formulary positioning, XCOPRI’s incremental share slows.

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How do payers influence XCOPRI revenue in the US?

Fast answer: Revenue growth is most sensitive to commercial formulary placement, prior authorization criteria, and patient cost-sharing. XCOPRI performs best when payers limit access friction for neurologists and do not over-constrain use to late-stage refractory populations.

Typical payer levers affecting XCOPRI

• Tier placement: Moves impact net pricing through patient share and adherence.
• PA duration and documentation requirements: Tight PA increases administrative friction.
• Copay assistance vs. patient eligibility caps: Controls real-world persistence and reduces “start and stop” cycles.
• Exclusions based on seizure classification: If plans narrow to specific focal seizure subsets or require certain diagnosis codes, access slows.

Financial impact channel

• Higher access reduces time-to-first-script and increases patient starts.
• Better copay support increases persistence through dose escalation and early tolerability.

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What patents protect XCOPRI and what does that mean for commercial durability?

Fast answer: XCOPRI’s branded revenue durability is supported by a patent estate covering the active ingredient and additional protection for formulations, dosing/titration regimens, and method-of-use. Patent expiration timing and any Orange Book-listed secondary patents determine generic leverage and Paragraph IV activity risk.

Patent estate mechanics that matter for revenue

• Primary ingredient protection sets the outer boundary for generic entry.
• Secondary Orange Book patents (process, formulation, dosing, and method-of-use) can create “layered” barriers that extend exclusivity even after marketing exclusivity ends.
• Listing coverage breadth affects the probability that challengers can carve out non-infringing formulations or dosing approaches.

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When does XCOPRI lose exclusivity and how does that affect generic entry risk?

Fast answer: Generic and biosimilar-like entry risk for cenobamate is tied to (1) legal expiration of patents listed in the Orange Book and (2) whether any remaining patents are successfully challenged or circumvented. The market’s financial trajectory becomes more volatile as litigation reaches the final stages and settlements set carve-out dates.

Generic entry “risk ladder” (how financial downside typically appears)

1. Pre-Paragraph IV: Stable branded revenues; market expects challenge rumors but no filing.
2. Paragraph IV filing: High volatility in forecast models due to possible 180-day exclusivity winners and settlement timing.
3. Injunction or automatic stay: Branded retains market share but margins can compress if price concessions begin.
4. Settlement with delayed entry: Revenue softens around the negotiated entry date.
5. Post-expiration launches: Rapid gross-to-net compression and volume share shift.

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What formulations and dosing regimens are protected by patents for XCOPRI?

Fast answer: Formulation and dosing-related protections are central to preventing easy generic “design-around” entry. For cenobamate, any patents covering composition, tablet characteristics, or dosing/titration regimens can delay generic launches by narrowing safe legal and technical pathways.

Patent categories that typically cover revenue-relevant design space

• Compositions of matter (active ingredient and related chemistry)
• Pharmaceutical compositions (tablet composition, excipients, particle characteristics)
• Dosing regimens (titration schedules and maintenance dosing)
• Method of use (patient population and seizure classification)

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What is the Orange Book status of XCOPRI?

Fast answer: XCOPRI is listed in the FDA Orange Book with multiple patents assigned to the NDA sponsor and/or patent holders. The Orange Book listing determines whether a generic challenger must address each listed patent with a Paragraph IV statement or accept patent expiry timing.

Why Orange Book breadth matters for market dynamics

• More listed patents increases the probability of multi-patent litigation.
• Multi-patent exposure increases the chance of incremental settlement terms that can extend entry.

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What patent litigation affects XCOPRI and where are the settlement and timing risks?

Fast answer: XCOPRI’s financial trajectory is sensitive to whether Paragraph IV challenges exist and whether settlements establish earlier or later generic entry. Litigation outcomes drive forecast dispersion and influence branded pricing and contracting strategy.

How litigation typically affects branded financial planning

• Revenue forecasts become scenario-based around settlement entry dates and 180-day exclusivity.
• Commercial teams implement defense pricing when a launch window is near.
• Net price pressure increases in the final 12–24 months before generic entry if payers anticipate competition.

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How does XCOPRI compare with competing antiseizure drugs on market access and competitive positioning?

Fast answer: XCOPRI’s competitive posture depends on (1) efficacy and tolerability positioning for focal seizures and (2) formulary access relative to both generics and newer branded add-ons.

Competitive set dynamics that matter financially

• Older branded comparators: Often affected by payer preference and generic migration.
• Newer branded therapies: Winning coverage can displace XCOPRI “next add-on” status.
• Generic add-ons: Where generic antiseizure drugs dominate formularies, XCOPRI’s incremental net sales depend on payer willingness to cover higher-cost branded options.

Pricing and access outcomes implied by competitive comparisons

• If payers consider XCOPRI “therapeutically differentiated,” net pricing holds longer.
• If payers treat it as substitutable to preferred add-ons, net pricing compresses faster.

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What generic entry risks exist for XCOPRI by route, strength, and regimen?

Fast answer: Generic entry risk is determined by which Orange Book patents are challenged, whether generic sponsors can design around dosing/regimen claims, and whether settlements set narrow carve-outs.

Route and product-form factor constraints

• Oral tablet/dose forms: Most generic activity targets oral dosage; any formulation patents can slow or narrow approvals.
• Strength-specific barriers: Patent coverage may differ by strength or manufacturing approach, affecting launch sequencing.

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How do label expansions or new indications affect XCOPRI’s revenue trajectory?

Fast answer: Revenue upside from label expansion comes when new usage categories expand prescriber eligibility and reduce payer constraints. If expanded indications increase patient pools without increasing coverage friction, adoption accelerates.

Financial linkage

• Broader label reduces “diagnosis gating.”
• It can change formulary architecture from narrow PA criteria to broader coverage rules.

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What is the manufacturing and IP risk for XCOPRI if a generic challenges?

Fast answer: Generic approvals require bioequivalence and compliance with any patent-related constraints. Where manufacturing process patents exist, challengers face additional barriers and settlement leverage increases.

Common technical/IP friction points

• Process patents: Can delay infringement assessments and settlement terms.
• Stability and dissolution specifications: Formulation patents can drive design-around needs.
• Titration and clinical endpoints: Method-of-use coverage can influence legal strategies.

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Where is XCOPRI’s revenue exposed to downside from market access pressure?

Fast answer: Downside concentrates in scenarios where payers tighten PA rules, reduce copay support, or prefer other add-on antiseizure drugs. The highest sensitivity is in the 12–24 months before any credible generic entry window.

Downside levers

• Higher PA burden: Reduces starts and retention.
• Net price compression: Increases gross-to-net through rebates.
• Channel mix changes: If buying shifts from community neurology to health systems with different contracting, net pricing can change quickly.
• Loss of formulary tiers: Tier mobility often triggers rapid share shifts.

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Key takeaways on XCOPRI’s market dynamics and financial trajectory

1. XCOPRI’s growth profile is driven by neurologist adoption for add-on focal seizures and payer coverage friction.
2. Financial durability depends on layered Orange Book protection that limits easy design-around generic entry.
3. Revenue volatility increases once Paragraph IV filings or litigation produces credible launch windows and settlement-defined entry dates.
4. Competitive share gains depend on formulary access versus both branded and generic add-on alternatives.
5. The strongest downside signals are payer step edits tightening and net price compression ahead of any generic entry expectation.

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FAQs

1) How do prior authorization and copay controls specifically affect XCOPRI patient starts?
PA requirements and copay levels directly impact time-to-treatment initiation and persistence during titration. More friction lowers new starts; stronger assistance improves retention.

2) What drives XCOPRI formulary placement among US commercial plans?
Plan decisions typically weight clinical differentiation, expected cost-offset from fewer uncontrolled seizures or fewer adverse-effect-driven discontinuations, and internal budget impact models.

3) How does Orange Book patent stacking change generic launch timing for cenobamate?
Multiple listed patents can force multiple legal positions or partial carve-outs, increasing the probability of multi-front litigation and later effective entry.

4) What settlement terms usually matter most for XCOPRI’s revenue forecasts?
Negotiated entry dates, scope of carve-outs (which strengths or indications), and whether any 180-day exclusivity is triggered.

5) Does XCOPRI face biosimilar-like dynamics?
No. Cenobamate is a small-molecule drug; the relevant competitive risk is generic substitution, not biosimilar competition.

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References (APA)

[No cited sources were provided in the prompt.]

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