LACOSAMIDE - Generic Drug Details

What are the generic 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, MSN, Regcon Holdings, Somerset Theraps Llc, Westminster Pharms, Zydus Pharms, Ucb Inc, Ajenat Pharms, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Kanchan Hlthcare, Novitium Pharma, Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Glenmark Pharms Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Msn Labs Pvt Ltd, Sciegen Pharms Inc, Sun Pharm, and Unichem, and is included in forty-four 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-six 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:	44
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	56
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	104
Patent Applications:	4,345
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
Wake Forest University Health Sciences	PHASE4
Belgium Health Care Knowledge Centre	NA
CMH Kharian Medical College	NA

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
Actavis Labs Fl Inc	LACOSAMIDE	lacosamide	TABLET;ORAL	204855-004	Jan 5, 2023		DISCN	No	No
Sciegen Pharms Inc	LACOSAMIDE	lacosamide	TABLET;ORAL	205237-001	Mar 17, 2022	AB	RX	No	No
Unichem	LACOSAMIDE	lacosamide	TABLET;ORAL	213109-004	Sep 4, 2024	AB	RX	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	022253-002	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

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/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

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)
World Intellectual Property Organization (WIPO)	2020244615
Canada	3148705	COMPOSITION PHARMACEUTIQUE DE LACOSAMIDE ET SA PREPARATION PHARMACEUTIQUE (LACOSAMIDE 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	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
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

Market Dynamics and Financial Trajectory for Lacosamide

Last updated: July 27, 2025

Introduction

Lacosamide (brand name Vimpat), a novel antiepileptic drug (AED), has established itself within the niche of neurological pharmacotherapy, primarily targeting focal seizures. Approved by the U.S. Food and Drug Administration (FDA) in 2008, lacosamide's unique mechanism—enhancing slow inactivation of voltage-gated sodium channels—differentiates it from older AEDs and positions it as a significant player in epilepsy management. Understanding lacosamide's evolving market dynamics and financial trajectory offers valuable insights for stakeholders, including pharmaceutical companies, investors, and healthcare policy planners.

Market Landscape and Therapeutic Positioning

Prevalence of Epilepsy and Market Demand

Epilepsy affects approximately 50 million people worldwide, with focal seizures comprising about 60% of adult cases (WHO, 2019). As a result, the global antiepileptic drug market is projected to reach USD 5.5 billion by 2027, growing at a compound annual growth rate (CAGR) of around 4%, driven by increasing prevalence and broader adoption of innovative therapies (Fortune Business Insights, 2022).

Lacosamide’s Clinical Edge

Lacosamide’s pharmacological profile suits patients with partial-onset seizures, either as adjunct or monotherapy. Its favorable tolerability profile, characterized by minimal cognitive impairment and manageable side effects, has facilitated its acceptance among neurologists. Regulatory approvals across multiple markets, including the U.S., Europe, and Japan, have broadened geographic reach. The drug’s positioning as a second-generation AED highlights its incremental value over traditional agents, emphasizing efficacy and improved safety.

Competitive Considerations

Lacosamide faces competition from a spectrum of AEDs, such as levetiracetam, lamotrigine, and carbamazepine. Its incremental differentiation hinges on its efficacy in refractory cases, compatibility with other medications, and reduced cognitive side effects. However, the advent of newer agents and the emergence of generic versions influence its market share dynamics.

Market Dynamics Influencing Lacosamide

Regulatory and Patent Trajectories

Initially protected by patents extending into the 2020s, lacosamide’s exclusivity has begun to diminish with patent expirations and the entry of generic competitors. The consolidation of market share post-patent expiry poses both challenges and opportunities—while generic pricing pressures compress revenues, increased accessibility can expand overall utilization.

Pricing and Reimbursement Policies

Pricing strategies and reimbursement frameworks across different regions substantially impact lacosamide sales. In developed markets like the U.S. and Europe, reimbursement coverage, formulary placements, and prescribing guidelines influence market penetration. Cost-effectiveness analyses favoring lacosamide, especially in refractory epilepsy, have facilitated favorable formulary placements.

Distribution Channels and Prescriber Dynamics

Neurologists and epileptologists are primary prescribers, with specialist oversight impacting uptake. Distribution channels—hospital pharmacies, retail pharmacies, and specialty clinics—differ by region. Education regarding its benefits and safety profile continues to be critical in expanding prescriber confidence.

Emerging Disease and Market Trends

The trend towards personalized medicine and biomarker-guided therapies could modify lacosamide's role, emphasizing its use in refractory cases and specific patient subsets. Additionally, the rising trend of polytherapy, where lacosamide's adjunct use is favored, sustains its demand.

Financial Trajectory and Revenue Forecasts

Historical Revenue Performance

Lacosamide's revenues grew steadily post-launch, peaking around USD 600 million globally in 2019. Precise figures fluctuate based on regional sales, patent status, and generic competition, with North America representing approximately 50-60% of sales (EvaluatePharma, 2021).

Impact of Patent Expiry and Generics

Patent expiration in major markets is anticipated between 2023-2025. Generic entrants are expected to reduce per-unit prices sharply—by up to 70%—while volumes could increase due to enhanced affordability and accessibility. This transition will shape revenue trajectories, potentially causing a decline in branded sales but an overall expansion in market penetration.

Forecasted Trends (2023-2030)

Analysts project that lacosamide’s global sales may experience a dip through 2025 due to generic competition. However, growth could stabilize or rebound as utilization shifts towards broader indications, including investigational uses in neuropathic pain and traumatic brain injury (Phase II trials). The total market for lacosamide is forecasted to decline modestly at a CAGR of 2-3% through the late 2020s, stabilizing at approximately USD 1.2 billion in sales by 2030.

Emerging Opportunities and Risks

• Expansion into Adjunct Indications: Clinical trials investigating lacosamide for neuropathic pain, mood disorders, and special populations could unlock new revenue streams, subject to regulatory approval.

• Generic Competition: The onset of biosimilars and generics remains the primary risk to revenue longevity.

• Pricing and Reimbursement Policies: Stricter cost containment measures threaten higher-margin sales, especially in publicly funded healthcare systems.

• Market Penetration in Emerging Economies: Increasing prevalence of epilepsy and expanding healthcare infrastructure in Asia-Pacific, Latin America, and Africa offer long-term growth opportunities.

Global Market Penetration and Key Region Analysis

North America

The U.S. remains the largest single market attributable to high epilepsy prevalence, advanced healthcare infrastructure, and robust reimbursement pathways. Despite impending patent expiration, strong brand loyalty and existing formulary placements sustain revenues. Strategic marketing and clinical evidence continue to underpin market dominance.

Europe

Regulatory approval through the European Medicines Agency (EMA) facilitated a mature market, with sales bolstered by reimbursements and neurologist endorsements. Price negotiations and health technology assessments (HTAs) influence market share.

Asia-Pacific

Rapid growth potential exists due to rising epilepsy prevalence, increasing healthcare expenditure, and expanding neurologist density. Nevertheless, regulatory complexities and price sensitivities require tailored market strategies.

Emerging Markets

Market entry and expansion in Latin America, Africa, and the Middle East are capitalized on by licensing agreements and local partnerships. Affordability remains a key barrier, mitigated by the introduction of generics.

Concluding Insights

Lacosamide exemplifies a therapeutically innovative yet increasingly commoditized antiseizure agent. Its market dynamics are shaped significantly by patent expirations, evolving clinical guidelines, and healthcare policies prioritizing cost-effectiveness. Financially, the drug’s trajectory will likely follow a decline in branded revenue post-patent expiry, complemented by volume-driven growth in emerging markets. Companies focusing on lifecycle management, such as expanding indications and geographic footprint, will be best positioned to leverage lacosamide’s enduring therapeutic niche.

Key Takeaways

• Patent expiration and generic competition will exert downward pressure on lacosamide’s revenues in mature markets starting in 2023–2025.
• Market expansion into emerging economies offers long-term growth opportunities, driven by rising epilepsy prevalence and healthcare infrastructure development.
• Clinical research into additional indications could mitigate revenue declines and unlock new revenue streams.
• Pricing and reimbursement strategies will be pivotal—aligning with healthcare policies ensures sustained market presence.
• Strategic lifecycle management, including differentiation and geographic expansion, can extend lacosamide’s financial viability.

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FAQs

1. How will patent expiration affect lacosamide’s market share?
Patent expiration will enable generic competitors to enter the market, leading to significant price reductions and potential erosion of branded revenues, although increased volume and broader access can partially offset declines.

2. What are the primary factors influencing lacosamide’s adoption in developing countries?
Cost sensitivity, healthcare infrastructure, regulatory approval processes, and availability of generics are key factors. Local partnerships and pricing strategies are essential for market penetration.

3. Are there emerging indications that could extend lacosamide’s market life?
Yes, ongoing clinical trials investigate its use in neuropathic pain, mood disorders, and neuroprotection, which could diversify its application beyond epilepsy.

4. How significant is the competition from other second-generation AEDs?
Competition is intense, with drugs like levetiracetam and lacosamide vying for refractory epilepsy niches. Differentiation based on tolerability and efficacy shapes competitive positioning.

5. What strategic priorities should pharmaceutical companies focus on to maximize lacosamide’s financial trajectory?
Lifecycle management through indication expansion, optimizing pricing and reimbursement strategies, strengthening presence in emerging markets, and clinical evidence generation are critical.

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References

1. World Health Organization. (2019). Epilepsy Fact Sheet.
2. Fortune Business Insights. (2022). Global Antiepileptic Drugs Market Size, Share & Industry Analysis.
3. EvaluatePharma. (2021). Annual Review of Global Epilepsy Drug Sales and Patent Status.