VIMPAT Drug Patent Profile

Which patents cover Vimpat, and what generic alternatives are available?

Vimpat is a drug marketed by Ucb Inc and is included in three NDAs.

The generic ingredient in VIMPAT is lacosamide. There are twenty-two drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vimpat

A generic version of VIMPAT was approved as lacosamide by ALEMBIC on March 17^th, 2022.

Summary for VIMPAT

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	51
Patent Applications:	2,633
Drug Prices:	Drug price information for VIMPAT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIMPAT
What excipients (inactive ingredients) are in VIMPAT?	VIMPAT excipients list
DailyMed Link:	VIMPAT at DailyMed

See drug prices for VIMPAT

Recent Clinical Trials for VIMPAT

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

Sponsor	Phase
Overseas Pharmaceuticals, Ltd.	Phase 1
Beijing Capton Pharmaceutical Technology Development Co., LTD	Phase 1
Indiana University	Phase 1

See all VIMPAT clinical trials

Pharmacology for VIMPAT

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for VIMPAT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIMPAT	Injection	lacosamide	10 mg/mL, 20 mL	022254	1	2016-06-30
VIMPAT	Tablets	lacosamide	50 mg, 100 mg, 150 mg, and 200 mg	022253	14	2012-10-29
VIMPAT	Oral Solution	lacosamide	10 mg/mL	022255	3	2012-10-29

US Patents and Regulatory Information for VIMPAT

VIMPAT is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008	AP	RX	Yes	Yes
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-002	Oct 28, 2008	AB	RX	Yes	No
Ucb Inc	VIMPAT	lacosamide	SOLUTION;ORAL	022255-001	Apr 20, 2010	AA	RX	Yes	Yes
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-001	Oct 28, 2008	AB	RX	Yes	No

Expired US Patents for VIMPAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-002	Oct 28, 2008	5,654,301
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-004	Oct 28, 2008	RE38551
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008	5,654,301
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-002	Oct 28, 2008	RE38551

EU/EMA Drug Approvals for VIMPAT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma SA	Vimpat	lacosamide	EMEA/H/C/000863Vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.	Authorised	no	no	no	2008-08-29
UCB Pharma S.A.	Lacosamide UCB	lacosamide	EMEA/H/C/005243Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.,	Authorised	no	no	no	2019-08-26
Accord Healthcare S.L.U.	Lacosamide Accord	lacosamide	EMEA/H/C/004443Lacosamide Accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.Lacosamide Accord is indicated as adjunctive therapy•         in 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 primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2017-09-18
Extrovis EU Ltd.	Lacosamide Adroiq	lacosamide	EMEA/H/C/006047Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.Lacosamide Adroiq is indicated as adjunctive therapyin the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2023-05-31

International Patents for VIMPAT

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

Country	Patent Number	Title	Estimated Expiration
Ireland	61437	Anticonvulsant composition containing amino acid derivative and use of said amino acid derivative
Japan	3145414
Australia	5371186
Spain	552348

Supplementary Protection Certificates for VIMPAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0888289	C00888289/01	Switzerland		PRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009
0888289	SPC001/2009	Ireland		SPC001/2009: 20091013, EXPIRES: 20220316
0888289	09C0006	France		PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/08/470/001 DU 20080829; REGISTRATION NO/DATE AT EEC: EU/1/08/470/001 DU 20080829
0888289	CA 2009 00001	Denmark

Market Dynamics and Financial Trajectory for VIMPAT (Lacosamide)

Last updated: November 20, 2025

Introduction

VIMPAT (lacosamide) stands as a crucial antiepileptic medication, approved by the FDA in 2009 for adjunctive therapy of partial-onset seizures. As a sodium channel modulator, VIMPAT has secured a significant position within the epilepsy treatment landscape. Its unique mechanism of action and favorable safety profile contribute substantially to its commercial success. This analysis evaluates the current market dynamics, competitive landscape, growth drivers, challenges, and financial trajectory shaping VIMPAT’s future.

Market Overview

The global antiepileptic drug (AED) market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% through 2028, driven by increasing epilepsy prevalence, unmet medical needs, and ongoing innovation. VIMPAT's global revenues, estimated at around $750 million in 2022, illustrate its established market presence (source: IQVIA). However, the competitive landscape is intensifying with newer therapies, biosimilars, and the clinical advancement of alternative AEDs.

Market Dynamics

1. Epilepsy Prevalence and Market Drivers

Epilepsy affects over 50 million worldwide, with an estimated 20-30% of patients resistant to first-line treatments. This persistent unmet need for effective, well-tolerated therapies sustains demand for second- and third-line options like VIMPAT. The rising aging population, which has a higher prevalence of epilepsy, further fuels market growth.

2. Competitive Landscape

VIMPAT competes primarily with other branded AEDs, including Carbatrol, Keppra (levetiracetam), Topiramate, and Lamictal (lamotrigine). While these drugs command significant market share, VIMPAT's distinctive profile—particularly its favorable tolerability, once-daily dosing, and fewer cognitive side effects—captures niche segments. Importantly, the arrival of generics post-2018 has challenged VIMPAT’s premium pricing and revenue potential. Pfizer’s exit from the VIMPAT franchise in 2020, transferring rights to Grünenthal, also impacts strategic positioning and resource allocation.

3. Regulatory and Prescribing Trends

Regulatory agencies continue to monitor safety signals; for VIMPAT, rare reports of arrhythmias and prolongation of PR interval necessitate cautious prescribing, especially in cardiac-compromised populations. Conversely, prescribers favor VIMPAT for its rapid titration and minimal drug-drug interactions, particularly beneficial in polytherapy contexts.

4. Market Expansion and New Indications

Extending VIMPAT’s indications, such as treatment for neuropathic pain or generalized seizures, can augment market size. Grünenthal's ongoing research into such applications may enhance long-term revenue; however, regulatory hurdles must be navigated.

5. Pricing and Reimbursement Environment

The pharmaceutical industry faces mounting pressure to contain costs and enhance access. VIMPAT's branded status initially enabled premium pricing, but generic competition post-2018 significantly reduced prices in many jurisdictions. Health insurers’ formulary restrictions and the push for biosimilars may further constrict revenue streams.

Financial Trajectory

1. Revenue Trends

VIMPAT’s revenues saw peak growth around 2014-2015 but have plateaued or declined slightly due to generic erosion and competitive pressures. In 2022, revenues were approximately $750 million globally. The transition of rights from Pfizer to Grünenthal introduced strategic reorientation, with an emphasis on optimizing market access and exploring new indications.

2. Profitability and Cost Structure

Gross margins have declined in the face of generic price erosion; however, Grünenthal’s optimized manufacturing and marketing strategies aim to sustain profitability. Investment in clinical trials for new indications and real-world evidence collection represents a significant, yet necessary, expense to future-proof revenues.

3. Future Growth Projections

Analysts forecast a subdued CAGR of around 2-3% for VIMPAT’s global sales over the coming five years, factoring in market saturation, competition, and pricing pressures. Conversely, niche extensions and optimization of existing markets could provide incremental growth. Emerging markets in Asia, Latin America, and Africa remain underpenetrated and represent high-potential expansion zones.

4. Impact of Biosimilars and Generics

The entry of generic lacosamide formulations post-patent expiry has significantly pressured VIMPAT’s premium pricing model. Although brand retention efforts and exclusive formulations persisted temporarily, price competition is expected to intensify further, constraining revenue growth in mature markets.

5. Strategic Initiatives

Grünenthal's strategic focus involves lifecycle management through development of new formulations (e.g., IV version) and exploring additional therapeutic indications. These initiatives aim to diversify revenue streams and mitigate generic competition’s impact.

Key Challenges and Opportunities

Challenges

• Generic Competition: Post-patent expiry, price erosion diminishes revenue, necessitating strategic diversification.
• Safety Monitoring: Emerging safety signals demand enhanced pharmacovigilance and risk mitigation.
• Market Saturation: Limited room for substantial growth in established markets unless new indications or formulations gain approval.
• Pricing Pressures: Healthcare payers increasingly favor cost-effective therapies, pressuring margins.

Opportunities

• New Indications: Expansion into neuropathic pain or other seizure types could broaden VIMPAT’s market.
• Emerging Markets: Growing healthcare infrastructure and epilepsy awareness in developing economies offer growth avenues.
• Formulation Innovations: IV formulations and combination therapies can improve adherence and clinical outcomes.
• Personalized Medicine: Pharmacogenomic insights may enable targeted use, enhancing efficacy and adoption.

Conclusion

VIMPAT’s market dynamics are shaped by a mature but competitive AED landscape, patent expiries, and evolving prescriber preferences. While revenue growth prospects face headwinds from generic competition, strategic initiatives such as indication expansion, formulation innovation, and market penetration in emerging economies offer paths to sustain the drug’s financial trajectory. Stakeholders must balance optimizing current assets with innovation to capitalize on latent growth opportunities within the epilepsy treatment ecosystem.

Key Takeaways

• Market saturation and generic competition have constrained VIMPAT’s growth, necessitating strategic diversification.
• Emerging indications and expanding into underserved geographical regions present growth opportunities.
• Pricing pressures from payers, coupled with safety considerations, will influence future market positioning.
• Lifecycle management through formulation and indication expansion is integral to sustaining revenue streams.
• Collaborative research and targeted marketing will be critical for Grünenthal in maximizing VIMPAT’s market potential.

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FAQs

Q1: How significant was the patent expiration for VIMPAT’s revenue?
Patent expiry in 2018 led to the entry of generics, resulting in prominent price erosion and a slowdown in revenue growth, although the drug retained brand recognition and prescriber loyalty.

Q2: What are the main competitors for VIMPAT in the epilepsy market?
VIMPAT competes with levetiracetam (Keppra), lamotrigine (Lamictal), topiramate, and carbamazepine, among others. Its differentiation lies in its tolerability profile and dosing convenience.

Q3: Are there any new indications being developed for VIMPAT?
Yes, Grünenthal is exploring additional uses such as neuropathic pain and other seizure types, aiming to expand the drug’s therapeutic scope.

Q4: What markets hold the most potential for VIMPAT’s growth moving forward?
Emerging markets in Asia, Latin America, and Africa offer significant growth, driven by increasing epilepsy prevalence and expanding healthcare infrastructure.

Q5: How does safety impact VIMPAT’s market position?
While generally well-tolerated, rare reports of cardiac conduction issues necessitate cautious use in specific populations, influencing prescribing patterns and regulatory monitoring.

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Sources:
[1] IQVIA Pharmaceutical Market Data, 2022.
[2] Grünenthal Press Releases, 2020.
[3] U.S. Food and Drug Administration, VIMPAT prescribing information, 2009.