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, Apotex, Aspiro, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly, Hikma, Indoco, MSN, Somerset Theraps Llc, Zydus Pharms, Ucb Inc, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Leading Pharma, 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-one 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. Forty-seven 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:	31
NDAs:	41
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	97
Patent Applications:	3,136
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
		50MG	TABLET;ORAL
		200MG	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
Dr Reddys	LACOSAMIDE	lacosamide	SOLUTION;INTRAVENOUS	217718-001	Mar 25, 2024	AP	RX	No	No
Aspiro	LACOSAMIDE	lacosamide	SOLUTION;INTRAVENOUS	216335-001	Sep 14, 2022	AP	RX	No	No
Accord Hlthcare	LACOSAMIDE	lacosamide	TABLET;ORAL	205011-002	Jul 12, 2022		DISCN	No	No
Macleods Pharms Ltd	LACOSAMIDE	lacosamide	TABLET;ORAL	208466-004	May 24, 2024	AB	RX	No	No
Apotex	LACOSAMIDE	lacosamide	SOLUTION;INTRAVENOUS	216670-001	Nov 13, 2023	AP	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	022253-004	Oct 28, 2008	RE38551
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-001	Oct 28, 2008	RE38551
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-003	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	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/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
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)
Canada	3148705	COMPOSITION PHARMACEUTIQUE DE LACOSAMIDE ET SA PREPARATION 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)
European Patent Office	3981390	COMPOSITION PHARMACEUTIQUE DE LACOSAMIDE ET SA PRÉPARATION 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	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
0888289	C300376	Netherlands		PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829

Lacosamide Market Analysis and Financial Projection Experimental

Lacosamide Market Dynamics and Financial Trajectory

Introduction to Lacosamide

Lacosamide is an anticonvulsant medication primarily used to treat epilepsy and neuropathic pain. Its efficacy in managing seizures and its favorable safety profile have made it a crucial drug in the neurological treatment landscape.

Market Size and Growth Projections

The global lacosamide market was valued at USD 5.8 billion in 2023 and is projected to reach USD 7.9 billion by 2031, growing at a compound annual growth rate (CAGR) of 4.7% from 2024 to 2031[1][3][5].

Key Drivers of Market Growth

Increasing Prevalence of Neurological Disorders

The rising incidence of epilepsy and other neurological disorders such as neuropathic pain and fibromyalgia is a significant driver of the lacosamide market. Epilepsy affects an estimated 50 million people globally, making it one of the most common neurological disorders[2].

Growing Aging Population

The global population aged 60 years and older is expected to reach 2.1 billion by 2050, according to the World Health Organization (WHO). This demographic shift increases the demand for lacosamide, as older adults are at a higher risk of developing epilepsy and other seizure-related conditions[2].

Advancements in Treatment Options

Lacosamide's efficacy in treating drug-resistant epilepsy and its expanding use cases in conditions like neuropathic pain and fibromyalgia are driving market growth. Ongoing research and clinical studies are exploring new medicinal applications, further boosting the market[1][2][5].

Emerging Markets

Emerging markets in Asia-Pacific, Latin America, and the Middle East are becoming lucrative destinations for lacosamide due to increasing healthcare investments, rising awareness, and improving healthcare infrastructure. Countries like India, China, and Brazil are expected to contribute significantly to market growth[2][4].

Regional Market Analysis

North America

North America currently dominates the lacosamide market, with the United States being the largest market due to the high prevalence of epilepsy and favorable regulatory environments. Canada also shows growing acceptance of antiepileptic medications[5].

Europe

Europe, led by Germany, France, and the U.K., is driven by advanced healthcare systems and increasing awareness of seizure disorders. The region's CAGR is expected to be around 3.5% from 2024 to 2031[3].

Asia-Pacific

The Asia-Pacific region, particularly China and Japan, is showcasing the fastest growth rate due to rising healthcare expenditure and government initiatives to enhance neurological care. The region's CAGR is expected to be around 7% from 2024 to 2031[3][5].

Latin America and Middle East & Africa

Latin America, led by Brazil and Mexico, and the Middle East & Africa, led by Turkey and the UAE, are also experiencing growth due to improving healthcare infrastructure and rising awareness of neurological conditions[3][5].

Market Opportunities and Investment Areas

Research and Development

Investment in research and development of lacosamide and its various formulations is expected to yield high returns. Companies focusing on expanding the range of lacosamide treatments, including pediatric, geriatric, and combination therapies, stand to capture a significant portion of the market[2].

Emerging Markets Expansion

The expansion of lacosamide in emerging markets presents lucrative business opportunities. Companies investing in local manufacturing and distribution partnerships in these regions can capitalize on the growing demand for effective epilepsy treatments[2].

Strategic Collaborations and Acquisitions

Strategic collaborations and acquisitions are expected to remain a key trend in the lacosamide market. Large pharmaceutical companies may seek partnerships with smaller firms to enhance product offerings and accelerate market penetration[2].

Market Challenges and Restraints

Regulatory Requirements and Safety Concerns

The market faces challenges such as stringent regulatory requirements and potential side effects of the drugs. The presence of cost-effective alternatives and the threat of generic drugs due to patent expirations also pose significant challenges[4][5].

Pricing Pressures and Supply Chain Disruptions

Pricing pressures and cost-related concerns, along with supply chain disruptions, can impact the availability and affordability of lacosamide, potentially hindering market growth[4].

Competitive Landscape

The lacosamide market is characterized by a competitive landscape dominated by major players such as UCB, Teva, and Amneal Pharmaceuticals. These companies enhance their market positions through robust research and development, strategic partnerships, and extensive distribution networks. Emerging challengers like Glenmark and Aurobindo Pharma are also making significant strides with aggressive pricing strategies and increasing R&D capabilities[5].

Innovations and Trends

Advancements in Drug Delivery Systems

Innovations in drug delivery systems and the exploration of new therapeutic uses are key trends in the lacosamide market. These advancements aim to improve efficacy and reduce side effects, enhancing patient adherence and outcomes[4][5].

Personalized Medicine

The shift towards personalized medicine is likely to impact market dynamics positively, enabling more effective treatment regimens tailored to individual patient needs[5].

Financial Trajectory

The financial trajectory of the lacosamide market is robust, with significant growth projected over the next several years. Here are some key financial highlights:

• Global Market Size: Expected to reach USD 7.9 billion by 2031 from USD 5.8 billion in 2023[1].
• CAGR: Projected at 4.7% from 2024 to 2031[1][3].
• Regional Growth: North America and Europe currently dominate, but the Asia-Pacific region is expected to show the fastest growth rate[3][5].

Key Takeaways

• The lacosamide market is driven by the increasing prevalence of neurological disorders and the growing aging population.
• Emerging markets in Asia-Pacific, Latin America, and the Middle East offer significant growth opportunities.
• Innovations in drug delivery systems and personalized medicine are key trends.
• Major players like UCB, Teva, and Amneal Pharmaceuticals dominate the market through robust R&D and strategic partnerships.
• The market faces challenges such as regulatory requirements, safety concerns, and pricing pressures.

FAQs

Q: What is the primary use of lacosamide? A: Lacosamide is primarily used to treat partial-onset seizures in adults and children with epilepsy and also for managing neuropathic pain[2].

Q: Which regions are expected to drive the growth of the lacosamide market? A: Emerging markets in Asia-Pacific, Latin America, and the Middle East are expected to drive significant growth due to increasing healthcare investments and improving healthcare infrastructure[2][4].

Q: What are the key challenges facing the lacosamide market? A: The market faces challenges such as stringent regulatory requirements, potential side effects, pricing pressures, and the threat of generic drugs due to patent expirations[4][5].

Q: Who are the major players in the lacosamide market? A: Major players include UCB, Teva, and Amneal Pharmaceuticals, with emerging challengers like Glenmark and Aurobindo Pharma also making significant strides[5].

Q: What is the projected CAGR for the lacosamide market from 2024 to 2031? A: The projected CAGR for the lacosamide market is around 4.7% to 5.4% from 2024 to 2031[1][3][5].

Cited Sources

1. Market Research Intellect: Lacosamide Market Size, Share, Growth | Global Report, 2031
2. Market Research Intellect: Lacosamide Market Soars: Key Drivers and Investment Opportunities in Neurological Treatment
3. Cognitive Market Research: Lacosamide Market Report
4. 360iResearch: Lacosamide Drugs Market Size & Share 2025-2030
5. OpenPR: Comprehensive Market Forecast for Lacosamide: Market Analysis