Lacosamide - Generic Drug Details

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.

Summary for lacosamide

International Patents:	6
US Patents:	3
Tradenames:	3
Applicants:	33
NDAs:	43
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	97
Patent Applications:	4,092
Drug Prices:	Drug price trends for lacosamide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lacosamide
What excipients (inactive ingredients) are in lacosamide?	lacosamide excipients list
DailyMed Link:	lacosamide at DailyMed

See drug prices for lacosamide

Recent Clinical Trials for lacosamide

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

Sponsor	Phase
Overseas Pharmaceuticals, Ltd.	Phase 1
Beijing Capton Pharmaceutical Technology Development Co., LTD	Phase 1
Wayne State University	Phase 4

See all lacosamide clinical trials

Generic filers with tentative approvals for LACOSAMIDE

Applicant	Application No.	Strength	Dosage Form
		10MG/ML	SOLUTION;ORAL
		200MG	TABLET;ORAL
		150MG	TABLET;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

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for lacosamide

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-001	May 4, 2023		RX	Yes	No			Y
Alkem Labs Ltd	LACOSAMIDE	lacosamide	SOLUTION;ORAL	214672-001	May 19, 2022	AA	RX	No	No
Hetero Labs Ltd V	LACOSAMIDE	lacosamide	TABLET;ORAL	204787-001	Mar 17, 2022	AB	RX	No	No
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008	AP	RX	Yes	Yes
Zydus Pharms	LACOSAMIDE	lacosamide	TABLET;ORAL	204947-001	Dec 15, 2023		DISCN	No	No
Amneal Pharms	LACOSAMIDE	lacosamide	TABLET;ORAL	204857-002	Mar 17, 2022		DISCN	No	No

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
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-001	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-001	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-002	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-004	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	SOLUTION;ORAL	022255-001	Apr 20, 2010

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

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)
European Patent Office	3981390	COMPOSITION PHARMACEUTIQUE DE LACOSAMIDE ET SA PRÉPARATION PHARMACEUTIQUE (LACOSAMIDE PHARMACEUTICAL COMPOSITION AND PHARMACEUTICAL PREPARATION THEREOF)
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)
Canada	3148705	COMPOSITION PHARMACEUTIQUE DE LACOSAMIDE ET SA PREPARATION PHARMACEUTIQUE (LACOSAMIDE PHARMACEUTICAL COMPOSITION AND PHARMACEUTICAL PREPARATION THEREOF)
World Intellectual Property Organization (WIPO)	2020244615
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)

Supplementary Protection Certificates for lacosamide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0888289	C300376	Netherlands		PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
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	SPC/GB09/007	United Kingdom		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

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.