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Last Updated: July 17, 2025

Lacosamide - Generic Drug Details


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What are the generic drug sources for lacosamide and what is the scope of patent protection?

Lacosamide is the generic ingredient in three branded drugs marketed by Aucta, Acella, Apotex, Aspiro, Dr Reddys, Fresenius Kabi Usa, Gland, Hainan Poly, Hikma, Indoco, MSN, Somerset Theraps Llc, Westminster Pharms, Zydus Pharms, Ucb Inc, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Medley Pharms, Novitium Pharma, Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Glenmark Pharms Ltd, Hetero Labs Ltd V, Kanchan Hlthcare, Macleods Pharms Ltd, Msn Labs Pvt Ltd, Sciegen Pharms Inc, Sun Pharm, and Unichem, and is included in forty-three NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lacosamide has six patent family members in four countries.

There are twenty-two drug master file entries for lacosamide. Fifty-one suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for lacosamide

See drug prices for lacosamide

Recent Clinical Trials for lacosamide

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

SponsorPhase
Overseas Pharmaceuticals, Ltd.Phase 1
Beijing Capton Pharmaceutical Technology Development Co., LTDPhase 1
Wayne State UniversityPhase 4

See all lacosamide clinical trials

Generic filers with tentative approvals for LACOSAMIDE
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free10MG/MLSOLUTION;ORAL
⤷  Try for Free⤷  Try for Free200MGTABLET;ORAL
⤷  Try for Free⤷  Try for Free150MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for lacosamide
Anatomical Therapeutic Chemical (ATC) Classes for lacosamide
Paragraph IV (Patent) Challenges for LACOSAMIDE
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 lacosamide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic LACOSAMIDE lacosamide TABLET;ORAL 204974-002 Mar 17, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Aucta MOTPOLY XR lacosamide CAPSULE, EXTENDED RELEASE;ORAL 216185-001 May 4, 2023 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Alkem Labs Ltd LACOSAMIDE lacosamide SOLUTION;ORAL 214672-001 May 19, 2022 AA RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hetero Labs Ltd V LACOSAMIDE lacosamide TABLET;ORAL 204787-001 Mar 17, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Ucb Inc VIMPAT lacosamide SOLUTION;INTRAVENOUS 022254-001 Oct 28, 2008 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Zydus Pharms LACOSAMIDE lacosamide TABLET;ORAL 204947-001 Dec 15, 2023 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Amneal Pharms LACOSAMIDE lacosamide TABLET;ORAL 204857-002 Mar 17, 2022 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for lacosamide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-004 Oct 28, 2008 ⤷  Try for Free ⤷  Try for Free
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-001 Oct 28, 2008 ⤷  Try for Free ⤷  Try for Free
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-001 Oct 28, 2008 ⤷  Try for Free ⤷  Try for Free
Ucb Inc VIMPAT lacosamide SOLUTION;INTRAVENOUS 022254-001 Oct 28, 2008 ⤷  Try for Free ⤷  Try for Free
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-002 Oct 28, 2008 ⤷  Try for Free ⤷  Try for Free
Ucb Inc VIMPAT lacosamide TABLET;ORAL 022253-004 Oct 28, 2008 ⤷  Try for Free ⤷  Try for Free
Ucb Inc VIMPAT lacosamide SOLUTION;ORAL 022255-001 Apr 20, 2010 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for lacosamide

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
UCB Pharma SA Vimpat lacosamide EMEA/H/C/000863
Vimpat 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/005243
Lacosamide 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/004443
Lacosamide 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/006047
Lacosamide 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for lacosamide

Country Patent Number Title Estimated Expiration
China 112043681 一种拉考沙胺药物组合物及其药物制剂 (Lacosamide pharmaceutical composition and pharmaceutical preparation thereof) ⤷  Try for Free
European Patent Office 3981390 COMPOSITION PHARMACEUTIQUE DE LACOSAMIDE ET SA PRÉPARATION PHARMACEUTIQUE (LACOSAMIDE PHARMACEUTICAL COMPOSITION AND PHARMACEUTICAL PREPARATION THEREOF) ⤷  Try for Free
China 114404393 一种拉考沙胺药物组合物及其药物制剂 (Lacosaxamide pharmaceutical composition and pharmaceutical preparation thereof) ⤷  Try for Free
Canada 3148705 COMPOSITION PHARMACEUTIQUE DE LACOSAMIDE ET SA PREPARATION PHARMACEUTIQUE (LACOSAMIDE PHARMACEUTICAL COMPOSITION AND PHARMACEUTICAL PREPARATION THEREOF) ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2020244615 ⤷  Try for Free
China 114173763 一种拉考沙胺药物组合物及其药物制剂 (Lacosaxamide pharmaceutical composition and pharmaceutical preparation thereof) ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lacosamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0888289 C300376 Netherlands ⤷  Try for Free PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
0888289 09C0006 France ⤷  Try for Free 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 SPC/GB09/007 United Kingdom ⤷  Try for Free PRODUCT NAME: LACOSAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE FORMS; REGISTERED: UK EU/1/08/470/001 20080829; UK EU/1/08/470/002 20080829; UK EU/1/08/470/003 20080829; UK EU/1/08/470/004 20080829; UK EU/1/08/470/005 20080829; UK EU/1/08/470/006 20080829; UK EU/1/08/470/014 20080829; UK EU/1/08/470/015 20080829; UK EU/1/08/470/016 20080829; UK EU/1/08/470/007 20080829; UK EU/1/08/470/008 20080829; UK EU/1/08/470/009 20080829; UK EU/1/08/470/010 20080829; UK EU/1/08/470/012 20080829; UK EU/1/08/470/013 20080829
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory of Lacosamide

Last updated: July 5, 2025

Introduction

In the fast-evolving pharmaceutical sector, drugs like lacosamide stand out as critical assets for treating neurological disorders, particularly epilepsy. As an antiepileptic medication marketed primarily as Vimpat by UCB Pharma, lacosamide has carved a niche in a market driven by rising seizure prevalence and innovative therapies. This analysis delves into its market dynamics and financial trajectory, offering insights for investors and executives navigating the complexities of drug commercialization and patent landscapes.

Overview of Lacosamide

Lacosamide represents a targeted advancement in epilepsy management, functioning as a sodium channel modulator to control partial-onset seizures. First approved by the U.S. Food and Drug Administration (FDA) in 2008, it gained expanded indications in subsequent years, including monotherapy for adults in 2017. UCB Pharma, the Belgian biotechnology firm, dominates its global distribution, leveraging lacosamide's efficacy to address a patient base exceeding 50 million epilepsy sufferers worldwide.

The drug's intellectual property framework has been pivotal, with core patents initially expiring in key markets like the U.S. and Europe between 2022 and 2025. This timeline introduces volatility, as generic entrants could disrupt pricing and market share. For business leaders, understanding these elements is essential for forecasting returns in a sector where R&D investments often exceed $1 billion per drug.

Current Market Dynamics

The lacosamide market operates within a broader antiepileptic drug segment valued at over $6 billion globally in 2023, with projections indicating steady growth at a 4-6% compound annual growth rate (CAGR) through 2030. Key factors fueling this expansion include an aging population and increasing diagnosis rates, particularly in emerging economies where epilepsy incidence rises due to improved healthcare access.

Regulatory hurdles remain a significant dynamic. The FDA and European Medicines Agency (EMA) enforce stringent post-marketing surveillance, as seen in lacosamide's label updates for rare side effects like atrial fibrillation. These requirements compel manufacturers like UCB to invest in pharmacovigilance, potentially adding 10-15% to operational costs. Conversely, opportunities arise from expanded use in pediatric populations, following EMA approvals in 2019, which broadened lacosamide's addressable market.

Competition intensifies market pressures. Lacosamide faces rivals such as levetiracetam and lamotrigine, offered by companies like GSK and generic producers. In 2023, generics captured nearly 30% of the epilepsy drug market share in the U.S., eroding branded product dominance. UCB counters this through strategic partnerships, such as collaborations with distributors in Asia-Pacific regions, where demand surges due to urbanization and better diagnostic tools.

Economic factors, including inflation and supply chain disruptions, further shape dynamics. For instance, global shortages of active pharmaceutical ingredients in 2022 temporarily constrained lacosamide availability, highlighting vulnerabilities in manufacturing networks. Executives must monitor these shifts, as they directly influence pricing strategies and market penetration.

Financial Trajectory

UCB Pharma's financial performance with lacosamide reflects a trajectory of robust growth followed by potential deceleration due to patent cliffs. In 2023, Vimpat generated approximately €1.2 billion in global sales, accounting for roughly 20% of UCB's total revenue. This figure marks a 7% year-over-year increase, driven by expanded indications and market penetration in high-growth regions like China and India.

Analyzing historical data, lacosamide's revenue peaked at €1.3 billion in 2021 before moderating amid generic competition. UCB's profitability benefits from a high gross margin, often exceeding 70%, attributed to efficient production and premium pricing in developed markets. However, net profits face dilution from R&D expenditures, which UCB allocates at around €500 million annually to sustain its pipeline.

Looking ahead, financial projections hinge on patent expirations. In the U.S., where generics entered in late 2022, sales could decline by 40-50% within three years, based on industry benchmarks for similar drugs. UCB anticipates offsetting this through biosimilar defenses and new formulations, such as extended-release versions launched in 2023, which may extend market exclusivity.

Global revenue forecasts estimate lacosamide's trajectory at a 3-5% CAGR through 2028, buoyed by emerging market expansion. For investors, this underscores the need for diversified portfolios, as UCB's stock valuation correlates closely with lacosamide's performance, with earnings per share projections rising 10% if patent strategies succeed.

Competitive Landscape

The competitive arena for lacosamide is crowded, with UCB contending against both branded and generic players. In the U.S., Teva Pharmaceuticals and Sandoz have introduced generics, slashing prices by up to 80% and capturing market share rapidly. This forces UCB to differentiate through marketing and real-world evidence studies demonstrating lacosamide's superior seizure control rates.

Internationally, partnerships play a crucial role. UCB's alliance with local distributors in Latin America has doubled lacosamide's market presence there since 2020, countering competition from Eisai's Fycompa. Pricing strategies vary; in Europe, UCB maintains premiums via value-based agreements with payers, linking reimbursements to patient outcomes.

Mergers and acquisitions add another layer, as seen in UCB's 2022 acquisition of Zogenix, which bolstered its neurology portfolio and indirectly supported lacosamide's positioning. For business professionals, this landscape signals opportunities in strategic alliances to mitigate competitive threats.

Future Outlook

Lacosamide's future hinges on innovation and adaptation. UCB is exploring combination therapies and digital health integrations, such as wearable seizure detection devices, to enhance patient adherence and create new revenue streams. By 2030, analysts predict the global epilepsy market could reach $8 billion, with lacosamide maintaining a 10-15% share if UCB navigates generics effectively.

Geopolitical factors, like trade tensions, pose risks to supply chains, potentially impacting export-dependent regions. However, advancements in personalized medicine could propel lacosamide forward, with genetic testing identifying ideal candidates and boosting demand. Executives should prioritize scenario planning, weighing best-case growth against worst-case patent erosion.

Key Takeaways

  • Lacosamide's market dynamics are shaped by steady growth in epilepsy treatments, regulatory challenges, and intensifying generic competition, with global sales exceeding €1 billion annually.
  • Financially, the drug has delivered strong revenue for UCB, but patent expirations threaten a 40-50% decline in key markets, necessitating strategic countermeasures.
  • Competition from established rivals and emerging players underscores the importance of innovation and partnerships for sustained market position.
  • Future prospects depend on expanded indications and emerging market penetration, offering potential for 3-5% CAGR despite headwinds.
  • Business leaders must focus on patent strategies and diversification to maximize returns in this volatile sector.

Frequently Asked Questions

  1. What factors are driving the growth of the lacosamide market?
    The primary drivers include rising epilepsy prevalence, expanded regulatory approvals for new patient groups, and increasing access in emerging markets, though generic entries pose challenges.

  2. How has UCB Pharma's revenue from lacosamide trended recently?
    UCB reported €1.2 billion in lacosamide sales for 2023, up 7% from the previous year, but projections indicate a slowdown due to patent expirations in major markets.

  3. What impact have generics had on lacosamide's market share?
    Generics have eroded about 30% of lacosamide's market share in the U.S. since 2022, compelling UCB to adopt pricing adjustments and focus on differentiated formulations.

  4. How might patent expirations affect lacosamide's financial trajectory?
    With patents expiring by 2025 in key regions, lacosamide's revenues could drop significantly, but UCB's pipeline expansions may mitigate losses through new product innovations.

  5. What opportunities exist for investors in lacosamide-related assets?
    Investors can target UCB's stock or partnerships in emerging markets, where demand for epilepsy treatments is growing, provided they account for competitive and regulatory risks.

Sources

  1. UCB Pharma. Annual Report 2023. Available at: UCB Investor Relations.
  2. U.S. Food and Drug Administration. Lacosamide Approval History. Available at: FDA Drugs@FDA.
  3. European Medicines Agency. Lacosamide Assessment Report. Available at: EMA Website.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.