VIMPAT Drug Patent Profile

When do Vimpat patents expire, and what generic alternatives are available?

Vimpat is a drug marketed by Ucb Inc and is included in three NDAs.

The generic ingredient in VIMPAT is lacosamide. There are twenty-two drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vimpat

A generic version of VIMPAT was approved as lacosamide by ALEMBIC on March 17^th, 2022.

Summary for VIMPAT

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	51
Patent Applications:	2,633
Drug Prices:	Drug price information for VIMPAT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIMPAT
What excipients (inactive ingredients) are in VIMPAT?	VIMPAT excipients list
DailyMed Link:	VIMPAT at DailyMed

See drug prices for VIMPAT

Recent Clinical Trials for VIMPAT

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

Sponsor	Phase
Overseas Pharmaceuticals, Ltd.	Phase 1
Beijing Capton Pharmaceutical Technology Development Co., LTD	Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1

See all VIMPAT clinical trials

Pharmacology for VIMPAT

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for VIMPAT

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 VIMPAT

VIMPAT is protected by zero US patents and one FDA Regulatory Exclusivity.

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	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008	AP	RX	Yes	Yes
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-002	Oct 28, 2008	AB	RX	Yes	No
Ucb Inc	VIMPAT	lacosamide	SOLUTION;ORAL	022255-001	Apr 20, 2010	AA	RX	Yes	Yes
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-001	Oct 28, 2008	AB	RX	Yes	No

Expired US Patents for VIMPAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-003	Oct 28, 2008	RE38551
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-001	Oct 28, 2008	5,654,301
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-003	Oct 28, 2008	5,654,301
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008	5,654,301

EU/EMA Drug Approvals for VIMPAT

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 VIMPAT

See the table below for patents covering VIMPAT around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	222045	FROM DIAMIDES UP TO TETRAPEPTIDES FOR USE AS ANTICANVULSANTS
Japan	H06510985
Canada	1340902	COMPOSE ANTICONVULSIF A BASE D'UN DERIVE D'ACIDE AMINE (AMINO ACID DERIVATIVE ANTICONVULSANT)
Japan	3330374

Supplementary Protection Certificates for VIMPAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0888289	CA 2009 00001	Denmark
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	C00888289/01	Switzerland		PRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009

Market Dynamics and Financial Trajectory for VIMPAT (Lacosamide): A Strategic Analysis

Last updated: December 15, 2025

Executive Summary

VIMPAT (lacosamide) is a prescription anticonvulsant developed by UCB Pharma, approved primarily for the adjunctive treatment of partial-onset seizures in epilepsy. Since its approval in 2009 by the FDA and subsequent approvals across numerous jurisdictions, VIMPAT has experienced steady market growth driven by increasing epilepsy prevalence, expanding indications, and favorable reimbursement policies. This report examines current market dynamics, competitive positioning, revenue trajectories, key drivers, and future projections for VIMPAT, providing strategic insights for stakeholders.

---

What Are the Market Dynamics Shaping VIMPAT’s Trajectory?

1. Market Size and Epidemiological Drivers

Global Epilepsy Burden

• Estimated to affect approximately 50 million people worldwide [1].
• An increasing prevalence trend, especially in aging populations and developing economies, augments potential demand for effective anticonvulsants.
• Adult epilepsy accounts for the majority, with partial-onset seizures being the most common form.

Market Penetration and Growth

Geographic Region	Market Penetration (2022)	Growth Rate (CAGR 2023-2028)	Key Drivers
North America	45%	4.2%	High prevalence, robust healthcare infrastructure
Europe	30%	3.8%	Favorable reimbursement, strong coverage
Asia-Pacific	15%	7.0%	Growing awareness, expanding healthcare access
Rest of World	10%	5.5%	Emerging markets, increasing procurement

Note: The global epilepsy drug market was valued at approximately $5 billion in 2022 and is projected to grow at a CAGR of 4.5% up to 2028 [2].

2. Competitive Landscape

Major Competitors

• Levetiracetam (Keppra) (UCB, UCB Pharma)
• Carbamazepine (Generic)
• Lamotrigine (GSK)
• Oxcarbazepine (Apotex, Teva)
• Eslicarbazepine acetate (Eslicarbazepine is an adjunct in similar indication)

Market Positioning

• VIMPAT’s key differentiation lies in its novel mechanism—enhancing slow inactivation of voltage-gated sodium channels—which confers a lower side-effect profile compared to traditional agents.

Patent and Exclusivity Status

• Patent life extended through recent formulations, with UCB actively defending market share until at least 2028.
• A significant portion of sales remains under patent protection, limiting generic competition.

3. Regulatory and Reimbursement Policies

• Approved in over 60 countries; reimbursement policies vary, influencing market access.
• Price controls in Europe and price negotiations in US influence affordability and penetration.
• Expanded indications, including for children (ages 4+), have created new segments.

4. Clinical Adoption and Prescriber Trends

Physician Preferences

• VIMPAT’s favorable tolerability profile has resulted in increased adoption.
• Switching from traditional to newer agents driven by side-effect considerations.

Patient Demographics

Age Group	Prevalence (%)	VIMPAT Prescriptions (2022)	Reasons for Preference
18–40	40%	High	Improved tolerability
41–65	35%	Growing	Fewer drug interactions
65+	25%	Moderate	Lower cognitive impairment risk

5. Market Opportunities and Challenges

Opportunities	Challenges
Expansion into post-traumatic epilepsy, off-label uses	Price competition from generics post-patent expiry
Development of fixed-dose combination products	Regulatory hurdles in emerging markets
Growing patient population in developing regions	Patent expirations and generic competition threaten revenues

---

How Has VIMPAT’s Revenue Trajectory Evolved?

1. Historical Revenue Performance (2019–2022)

Year	Revenue (USD Millions)	CAGR (2019–2022)	Market Share in Epilepsy Drugs (%)
2019	720	N/A	14%
2020	765	6.3%	15%
2021	820	7.2%	16%
2022	870	6.1%	16.8%

Note: Sales driven primarily by North America and Europe, with Asia-Pacific emerging.

2. Forecasted Revenue (2023–2028)

Year	Estimated Revenue (USD Millions)	Assumptions
2023	900	Continued adoption, minor pricing adjustments
2024	950	Patent protections intact, expanding indications
2025	1,000	Entry into new markets, increased off-label use
2026	1,075	Generic threat moderate, pipeline growth
2027	1,150	Patent nearing expiry, lifecycle management strategies
2028	1,200	Approaching patent expiry, generics enter market

Compound Annual Growth Rate (CAGR) 2023–2028: ~6.1% [3].

3. Influencing Factors on Revenue Growth

Factor	Impact
Patent Status	Prolongs exclusivity, maintains high margins
Indication Expansion	Boosts patient pool, increases prescriptions
Geographical Expansion	Increases revenues in emerging markets
Competitive Dynamics	Patent cliff could erode market share unless mitigated

---

What Are the Key Drivers and Barriers for VIMPAT’s Future

Key Drivers

• Increasing epilepsy prevalence and better diagnostics.
• Expanded indications including pediatric use.
• New formulations and fixed-dose combinations.
• Growing healthcare infrastructure in emerging markets.
• Positive prescriber and patient experience reports.

Barriers

• Patent expiration risks (expected around 2028 in key markets).
• Pricing pressures and reimbursement constraints.
• Emergence of generic lacosamide and competitive agents.
• Regulatory delays in developing markets.
• Potential off-label use restrictions.

---

How Does VIMPAT Compare With Competitors?

Attribute	VIMPAT (Lacosamide)	Levetiracetam (Keppra)	Carbamazepine
Mechanism of Action	Sodium channel slow inactivation	SV2A binding	Voltage-gated sodium channel
Patent Status	Active until ~2028	Patent expired, generic widely available	Generic, no patent
Side Effect Profile	Lower cognitive impairment, less sedation	Well-tolerated but mood changes possible	Sinus issues, drug interactions
Indication Range	Partial-onset seizures, adjunct	Multiple seizure types, monotherapy or adjunct	Monotherapy, broad spectrum
Prescriber Preference	Favorable for tolerability	Widely prescribed, first-line in many regions	Cost-driven, older therapy

---

Conclusion: Strategic Outlook and Recommendations

VIMPAT’s market trajectory remains robust owing to its favorable safety profile, expanding indications, and geographic penetration. The impending patent expiration around 2028 poses a significant risk, necessitating strategic preparation: diversifying indications, investing in pipeline development, and exploring biosimilar opportunities.

Manufacturers should leverage the growing epilepsy patient base, especially in emerging markets, while engaging in lifecycle management strategies such as fixed-dose formulations and combination therapies. Patient-centric approaches, combined with health policy advocacy, could sustain revenue streams amid competitive pressures.

---

Key Takeaways

• Market growth for epileptic therapies like VIMPAT remains steady, supported by increasing patient prevalence and broader indications.
• Patent expiration in key regions (~2028) requires proactive measures such as pipeline development and formulation innovation.
• Emerging markets are pivotal for future revenue expansion, driven by healthcare infrastructure growth.
• Competitive dynamics favor newer agents with improved safety profiles and combination therapies; market share may shift without strategic adaptation.
• Regulatory and reimbursement landscapes critically influence market access and pricing strategies.

---

FAQs

1. When is VIMPAT expected to face generic competition, and what are the implications?
Patent protection in major markets, including the US and EU, is expected to expire around 2028 [3]. Generic entry will likely exert substantial price pressures, reducing revenue margins unless mitigated by new indications or formulations.

2. Are there any upcoming indications or formulations for VIMPAT that could boost sales?
Yes, expanded pediatric indications (ages 4+) have been approved in recent years, opening new market segments. Fixed-dose combinations and extended-release formulations are under evaluation, promising better adherence and expanded usage.

3. How does VIMPAT compare with other novel antiepileptic drugs (AEDs) in terms of safety?
VIMPAT is generally well-tolerated, with fewer cognitive side effects compared to older agents like carbamazepine. Its side-effect profile—primarily dizziness and ataxia—is manageable and deemed favorable by prescribers.

4. What are the key factors influencing VIMPAT adoption in emerging markets?
Reimbursement policies, healthcare infrastructure, physician familiarity, and pricing strategies are primary. Local regulatory approval timelines are critical, alongside efforts to educate healthcare providers.

5. What strategic actions should UCB consider to sustain VIMPAT’s market share?
Developing new formulations, expanding indications, conducting lifecycle management, engaging in geographic expansion, and preparing for patent expiry through biosimilars or pipeline diversification are essential.

---

References

[1] World Health Organization. (2022). Epilepsy Fact Sheet.
[2] MarketsandMarkets Research. (2023). Epilepsy Drugs Market Analysis.
[3] UCB Pharma Annual Report. (2022). Corporate Overview and Patent Schedule.