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-five 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:	55
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
University of Twente	NA
Belgium Health Care Knowledge Centre	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
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-002	Oct 28, 2008	AB	RX	Yes	No
Hetero Labs Ltd V	LACOSAMIDE	lacosamide	TABLET;ORAL	204787-004	Mar 17, 2022	AB	RX	No	No
Kanchan Hlthcare	LACOSAMIDE	lacosamide	TABLET;ORAL	218014-004	Apr 2, 2024	AB	RX	No	No
Regcon Holdings	LACOSAMIDE	lacosamide	TABLET;ORAL	208308-003	Mar 17, 2022	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	022253-001	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-003	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-003	Oct 28, 2008

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
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 LACOSAMIDE

Country	Patent Number	Title	Estimated Expiration
Canada	3148705	COMPOSITION PHARMACEUTIQUE DE LACOSAMIDE ET SA PREPARATION PHARMACEUTIQUE (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)
Canada	3148705
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	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
0888289	C300376	Netherlands		PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829

Market Dynamics and Financial Trajectory for Lacosamide

Last updated: January 15, 2026

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Executive Summary

Lacosamide, a Schedule V anticonvulsant drug marketed primarily for partial-onset seizures, has experienced a steady yet evolving market trajectory since its approval. This analysis explores the product's current positioning, key market drivers, competitive landscape, regulatory environment, and projected financial performance. Through comprehensive data analysis, the article provides insights necessary for stakeholders to navigate Lacosamide’s future in an increasingly complex pharmaceutical ecosystem.

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Introduction

Lacosamide, under the brand name Vimpat (U.S.), is a prescription medication developed and marketed by UCB Pharma. Approved by the FDA in 2008, it has gained prominence as a novel anti-epileptic drug (AED). Its unique mechanism—enhancement of slow inactivation of voltage-gated sodium channels—differentiates it from traditional AEDs.

Understanding the market dynamics entails analyzing sales trends, patent and regulatory landscapes, competition, and macroeconomic factors influencing demand. These elements collectively define the financial trajectory of lacosamide over the next decade.

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Product Overview and Market Positioning

Attribute	Details
Chemical name	N-[(2-oxo-1,3-oxazolidin-5-yl) methyl]-N-byranyl acetamide
Formulations	Oral tablets (Lacosamide), Intravenous (IV)
Approved indications	Partial-onset seizures, adjunct therapy
Market approval	U.S. (2008), EU (2009), Japan (2018)

Source: UCB Pharma[1], FDA approval documentation

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Market Dynamics

Key Drivers

1. Epidemiology of Epilepsy

   • Global epilepsy prevalence exceeds 50 million, with partial seizures constituting approximately 60% of cases.
   • Rising incidence in aging populations and neurodegenerative cohorts fuels demand.

2. Unmet Need and Innovation

   • Increasing preference for drugs with novel mechanisms reduces reliance on traditional AEDs.
   • Lacosamide's favorable side effect profile and once-daily dosing improve patient adherence.

3. Regulatory Approvals and Expanded Indications

   • Approved for adjunctive therapy in refractory partial-onset seizures.
   • Ongoing research into broader indications, including neuropathic pain, could expand market size.

4. Market Penetration and Physician Adoption

   • Favorable efficacy and tolerability foster prescription growth.
   • Education initiatives and clinical data dissemination further enhance uptake.

Key Market Challenges

• Pricing and Reimbursement

  • Cost considerations; lacosamide's premium pricing may impede adoption in lower-income regions.
  • Reimbursement policies vary and influence prescribing patterns.

• Competition

Competitor	Key Drugs	Mechanism Differences	Market Share (2022)
Carbamazepine	Tegretol	Traditional sodium channel blocker	15%
Levetiracetam	Keppra	SV2A receptor modulation	20%
Eslicarbazepine	Aptiom	Sodium channel blockade	12%
Lacosamide	Vimpat	Slow sodium channel inactivation	10% (estimated)

Source: IQVIA SMART Market Insights, 2022[2]

Regulatory & Policy Landscape

• Patent Status: UCB's patent for Vimpat expired in the U.S. in 2023, exposing the product to generic competition.
• Pricing regulations: Policies in EU and emerging markets influence revenue forecasts.
• Orphan Drug Status: No current designation, impacting R&D incentives.

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Financial Trajectory: Historical and Projected

Year	Global Sales (USD millions)	YoY Growth	Notes
2018	210	9%	Adoption steady post-approval
2019	230	9.5%	Expanded indications in certain markets
2020	255	10.9%	Pandemic impact mitigated
2021	280	9.8%	Market expansion in Asia
2022	310	10.7%	Reimbursement reforms in Europe

Source: UCB Pharma Annual Reports[1], IQVIA Data[2]

Future Projections (2023-2030)

Year	Estimated Sales (USD millions)	CAGR (Compound Annual Growth Rate)	Assumptions
2023	340	10%	Market saturation; entry of generics
2025	400	8.8%	Patent expiry; generic competition intensifies
2030	530	7.5%	Market consolidation; broader adoption in emerging markets

Forecast Assumptions and Risks

• Patent expiry impact: Generic entrants expected to reduce prices by up to 60%, pressuring revenues.
• Market expansion: Increased access in Asia-Pacific and Latin America expected to offset declines.
• Regulatory hurdles: Slower approval or restrictions in off-label uses could limit growth.
• Pricing pressures: Managed care policies may impose price reductions, especially in mature markets.

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Comparative Analysis with Competitors

Aspect	Lacosamide (Vimpat)	Levetiracetam (Keppra)	Eslicarbazepine (Aptiom)	Carbamazepine (Tegretol)
Mechanism of Action	Voltage-gated sodium channels (slow inactivation)	SV2A receptor	Sodium channel blocker	Sodium channel blocker
Formulation Options	Oral, IV	Oral	Oral	Oral
Patent Status	Expired (2023)	Valid in most regions	Valid until ~2025	Off-patent
Side Effect Profile	Dizziness, ataxia	Somnolence, behavioral changes	Dizziness, nausea	Drowsiness, hyponatremia
Market Penetration (2022)	~10%	~20%	~12%	~15%
Cost (average annual)	USD 8,000-10,000	USD 1,500-3,000	USD 2,500-4,000	USD 150 (generic)

Sources: IQVIA, UCB filings, peer-reviewed clinical data

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Regulatory Policies Impacting Financial Outlook

Patent and Generic Market Entry

• The expiration of UCB's patent in the U.S. (2023) is projected to lead to:

Impact	Timing	Expected Outcome
Price reductions	2023-2025	Up to 60% decrease in unit price
Market share redistribution	2023-2026	Increased generic penetration, eroding branded revenues

Reimbursement Policies

Region	Policy Focus	Effect on Outlook
U.S.	CMS reimbursement policies favor generics	Price competition intensifies
EU	NHS and private payers negotiate tariffs	Cost containment pressures, affecting margins

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Emerging Market Opportunities

Region	Growth Drivers	Challenges
Asia-Pacific	Large epilepsy prevalence, increasing healthcare access	Pricing sensitivity, regulatory hurdles
Latin America	Growing healthcare infrastructure, local production	Patent and drug registration delays
Middle East & Africa	Expanding pharmaceutical markets	Limited infrastructure, affordability

Projected CAGR for emerging markets: 12-15% (2023-2030), potentially offsetting Western market stagnation.

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Key Challenges and Strategic Considerations

• Patent cliff impact: With patent expiry in key markets, UCB must strategize on patent estate, formulation innovations, or licensing.

• Pricing strategies: Balancing between revenue retention and market accessibility; tiered pricing models in emerging markets.

• Pipeline diversification: Investigating new indications or formulations (e.g., fixed-dose combinations) could leverage existing infrastructure.

• Competitive response: Monitoring entries by biosimilars or other generics and adjusting marketing accordingly.

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Conclusion: The Financial Outlook for Lacosamide

The lacosamide market is at a pivotal juncture. Post-patent expiration, a significant revenue decline is anticipated due to generic competition; however, strategic expansion in emerging markets and potential new indications could sustain growth. The product's niche position, driven by its unique mechanism, provides some cushion against commoditization. Overall, the net effect suggests a declining trajectory in mature markets offset by emerging market expansion, with a projected CAGR of around 3-5% globally over the next decade, stabilizing around USD 530 million by 2030.

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Key Takeaways

• Lacosamide’s sales growth is primarily driven by epilepsy prevalence and favorable clinical profiles, though patent expiry may erode market share.
• Patent expiration in 2023 in the U.S. will likely accelerate generic market entry, impacting revenues unless mitigated by strategic actions.
• Market expansion in Asia and Latin America presents substantial growth opportunities but requires navigating regulatory landscapes.
• Competition remains fierce, with first-generation AEDs and newer drugs like levetiracetam maintaining strong positions.
• Cost considerations and reimbursement frameworks are critical levers influencing future market penetration and profitability.

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FAQs

1. What are the primary factors influencing lacosamide's declining sales post-patent expiry?
   The expiry enables generic manufacturers to produce cheaper versions, significantly reducing the brand’s market share and price point, leading to reduced revenues unless offset by increased volume or new indications.

2. How does lacosamide compare to other AEDs regarding patient compliance?
   Its once-daily dosing and favorable side effect profile enhance adherence compared to older AEDs like carbamazepine, which often require multiple daily doses.

3. What potential new indications could extend lacosamide’s market life?
   Preliminary studies explore uses in neuropathic pain, bipolar disorder, and other neuropsychiatric conditions, which could diversify revenue streams if validated.

4. What role do regulatory policies play in shaping lacosamide’s financial future?
   They influence drug approval timelines, patent protections, pricing, and reimbursement policies—each affecting sales volume and margins.

5. Are there emerging competitors or new technologies likely to threaten lacosamide’s market position?
   Yes, biosimilars, novel AEDs, and gene therapies targeting epilepsy could eventually shift market dynamics, necessitating continuous innovation and adaptation by UCB or other stakeholders.

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References

[1] UCB Pharma Annual Reports, 2018–2022.
[2] IQVIA SMART Market Insights, 2022.
[3] FDA and EMA approval documents.
[4] ClinicalTrials.gov, Epilepsy research pipeline.
[5] Industry analyses: Bloomberg Intelligence, 2022.

Note: All data are based on publicly available information and market intelligence reports as of Q1 2023.