ELEPSIA XR Drug Patent Profile

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

Elepsia Xr is a drug marketed by Tripoint and is included in one NDA. There are five patents protecting this drug.

This drug has twenty-five patent family members in eighteen countries.

The generic ingredient in ELEPSIA XR is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-four suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Elepsia Xr

A generic version of ELEPSIA XR was approved as levetiracetam by MYLAN on November 4^th, 2008.

Summary for ELEPSIA XR

International Patents:	25
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	132
What excipients (inactive ingredients) are in ELEPSIA XR?	ELEPSIA XR excipients list
DailyMed Link:	ELEPSIA XR at DailyMed

Pharmacology for ELEPSIA XR

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

US Patents and Regulatory Information for ELEPSIA XR

ELEPSIA XR is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-001	Dec 20, 2018		DISCN	Yes	No			Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-002	Dec 20, 2018		DISCN	Yes	No			Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-001	Dec 20, 2018		DISCN	Yes	No			Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-002	Dec 20, 2018		DISCN	Yes	No			Y
Tripoint	ELEPSIA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204417-001	Dec 20, 2018		DISCN	Yes	No			Y

EU/EMA Drug Approvals for ELEPSIA XR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma SA	Keppra	levetiracetam	EMEA/H/C/000277Keppra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Keppra is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	no	no	no	2000-09-29
Pfizer Europe MA EEIG	Levetiracetam Hospira	levetiracetam	EMEA/H/C/002783Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.Levetiracetam Hospira is indicated as adjunctive therapyin the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.	Authorised	yes	no	no	2014-01-07
Accord Healthcare S.L.U.	Levetiracetam Accord	levetiracetam	EMEA/H/C/002290Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03
Pharmathen S.A.	Matever	levetiracetam	EMEA/H/C/002024Matever is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Matever is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03
Actavis Group PTC ehf	Levetiracetam Actavis	levetiracetam	EMEA/H/C/002355Levetiracetam Actavis is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam Actavis is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03

International Patents for ELEPSIA XR

See the table below for patents covering ELEPSIA XR around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2011200881
South Korea	20060076307
Austria	551051
World Intellectual Property Organization (WIPO)	2005039481
Australia	2004283565

Supplementary Protection Certificates for ELEPSIA XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0162036	C300028	Netherlands		PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
0162036	2000C/032	Belgium		PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329

Market Dynamics and Financial Trajectory for ELEPSIA XR

Last updated: July 30, 2025

Introduction

ELEPSIA XR (lacosamide extended-release), marketed by UCB Pharma, stands as an important medication in the treatment of partial-onset seizures in epilepsy patients. Its unique pharmacological profile, patent landscape, and evolving competitive environment shape its market trajectory. This analysis offers an in-depth examination of current market dynamics, forecasting its financial trajectory amid industry trends.

Pharmacological Profile and Therapeutic Positioning

ELEPSIA XR’s extended-release formulation delivers a steady therapeutic plasma concentration of lacosamide, enhancing patient adherence and tolerability. Approved by the FDA in 2017, it targets adults with partial-onset seizures, including those with uncontrolled epilepsy. The drug's mechanism focuses on stabilizing hyperexcitable neuronal membranes, reducing seizure frequency (FDA, 2017). Its once-daily dosing and favorable safety profile position it favorably among adjunctive therapies.

Market Landscape

Global Epilepsy Drug Market Overview

The global epilepsy market is projected to reach approximately $4.7 billion by 2026, with a compound annual growth rate (CAGR) of around 4.8% from 2021 to 2026 (Fortune Business Insights, 2021). Rising prevalence rates—estimated at 50 million worldwide—along with increased diagnosis and expanding treatment options fuel this growth.

ELEPSIA XR’s Position in the Market

ELEPSIA XR competes primarily with branded and generic formulations of lacosamide and other new-generation antiepileptic drugs (AEDs) such as lamotrigine, levetiracetam, and brivaracetam. Despite stiff competition, ELEPSIA XR benefits from its extended-release formulation, which offers dosing convenience and potentially better compliance—a critical factor in chronic epilepsy management.

Patent Status and Market Exclusivity

UCB Pharma’s patent for ELEPSIA XR was granted in 2017, with expected expiry around 2032, offering a window for market expansion and revenue growth. Patent protections are crucial in safeguarding market share against generic entrants, which typically erode branded revenues within 5-7 years of patent expiration.

Regulatory Environment

Regulatory agencies have shown increasing openness toward innovative formulations. The FDA’s recent approval pathways for extended-release AEDs, including latency to patent expiry, influence ELEPSIA XR’s market sustainability.

Market Drivers

• Growing Epilepsy Prevalence: An aging population and improved diagnosis contribute to higher treatment rates.
• Enhanced Patient Compliance: Once-daily dosing and mitigated side effects improve adherence.
• Healthcare Provider Preference: Physicians favor drugs with proven efficacy and tolerability, bolstered by real-world evidence.
• Post-Approval Expansion: UCB’s initiatives for label expansion and geographic penetration are pivotal.

Market Challenges

• Generic Competition: Upon patent expiry, generic lacosamide formulations threaten revenues.
• Cost Considerations: Price sensitivity impacts adoption, especially in cost-conscious healthcare systems.
• Competing Therapies: The emergence of novel AEDs with superior efficacy or safety profiles may diminish ELEPSIA XR’s attractiveness.
• Market Access and Reimbursement: Variability in insurance coverage across regions influences patient access.

Financial Trajectory Analysis

Revenue Projections

Based on industry data, UCB’s global epilepsy franchise generated approximately $1.2 billion in 2022, with lacosamide-based products contributing a significant share (UCB Annual Report, 2022). Assuming ELEPSIA XR accounts for 20-25% of lacosamide revenues, its global sales could reach upwards of $250 million by 2025, considering moderate market expansion and increased acceptance.

Growth Factors

• Market Penetration: As a once-daily extended-release formulation, ELEPSIA XR's adoption is expected to increase among neurologists and epileptologists.
• Geographical Expansion: Emerging markets, with increasing healthcare infrastructure, present untapped potential—particularly in Asia and Latin America.
• Post-Patent Strategies: UCB’s pipeline and potential for label extensions could sustain growth beyond patent expiry.

Potential Risks

• Patent Litigation and Challenges: Patent disputes could delay market exclusivity.
• Price Erosion: Entry of generics post-2029 will likely reduce revenue margins.
• Market Saturation: Competition from other AEDs and combination therapies could limit growth opportunities.

Strategic Outlook and Opportunities

UCB’s focus on expanding access and reinforcing clinical value propositions through real-world studies enhances ELEPSIA XR’s market stance. Partnerships and licensing in emerging markets will diversify revenue streams. Innovation, such as developing fixed-dose combinations or biomarkers for personalized therapy, can further expand its footprint.

Conclusion

ELEPSIA XR’s market dynamics hinge on its pharmacological benefits, patent landscape, and competitive environment. While high barriers exist through patent protections, the inevitable wave of generic competition post-2032 necessitates strategic brand management. Its financial trajectory appears robust through the next decade, driven by rising epilepsy prevalence, formulation advantages, and geographic expansion.

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Key Takeaways

• Strong Position Amidst Competition: ELEPSIA XR's extended-release profile offers a distinctive treatment advantage, bolstering its market share among AEDs.
• Patent Lifecycle Critical: Its patent protection until approximately 2032 provides a window for revenue maximization, after which generic competition will intensify.
• Emerging Markets as Growth Engines: Expansion into underserved regions presents significant upside potential.
• Pipeline and Innovation: Future label extensions or combination therapies are vital for sustaining long-term growth.
• Market Risks: Patent challenges, cost pressures, and competing therapies require vigilant market strategy adaptation.

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FAQs

1. When is ELEPSIA XR expected to face generic competition, and how will it impact revenues?

Patent expiration around 2032 signals the onset of generic competition, which typically results in significant revenue erosion within 5-7 years post-expiry if not mitigated by new formulations or indications.

2. What differentiates ELEPSIA XR from other lacosamide formulations?

Its extended-release formulation ensures a steadier plasma concentration, reducing dosing frequency to once daily, which enhances adherence and tolerability.

3. How are emerging markets influencing ELEPSIA XR’s growth prospects?

Growing healthcare infrastructure, increased epilepsy awareness, and rising treatment rates create substantial opportunities for market entry and expansion in regions like Asia and Latin America.

4. What strategic moves can UCB undertake to maximize ELEPSIA XR’s market potential?

Expanding geographic coverage, pursuing label extensions, investing in real-world evidence, and developing fixed-dose combinations can strengthen its position.

5. What are the main competitive threats to ELEPSIA XR in the coming decade?

Generic entry post-patent expiry, new AEDs with better efficacy or safety, and pricing pressures from healthcare systems are primary challenges.

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References

[1] FDA. (2017). FDA approves new medication for partial-onset seizures.
[2] Fortune Business Insights. (2021). Epilepsy Drugs Market Size, Share & Industry Analysis.
[3] UCB Pharma. (2022). Annual Report and Financial Statements.