VIMPAT Drug Patent Profile

When do Vimpat patents expire, and when can generic versions of Vimpat launch?

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. Forty-seven 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:	86
Clinical Trials:	51
Patent Applications:	1,929
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
Beijing Capton Pharmaceutical Technology Development Co., LTD	Phase 1
Overseas Pharmaceuticals, 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 two FDA Regulatory Exclusivities.

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	022253-004	Oct 28, 2008	AB	RX	Yes	Yes
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-002	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	022253-001	Oct 28, 2008	RE38551
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-003	Oct 28, 2008	5,654,301
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-004	Oct 28, 2008	RE38551
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-002	Oct 28, 2008	RE38551
Ucb Inc	VIMPAT	lacosamide	SOLUTION;ORAL	022255-001	Apr 20, 2010	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/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 VIMPAT

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

Country	Patent Number	Title	Estimated Expiration
Australia	595538
Japan	2000505476
Japan	2002241355	AMINO ACID DERIVATIVE ANTICONVULSANT
Japan	3330374
European Patent Office	0400440	Dérivés anticonvulsifs d'aminoacides (Amino acid derivative anticonvulsant)

Supplementary Protection Certificates for VIMPAT

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	C300376	Netherlands		PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
0888289	C00888289/01	Switzerland		PRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009
0888289	SPC001/2009	Ireland		SPC001/2009: 20091013, EXPIRES: 20220316
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

VIMPAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VIMPAT

Introduction

VIMPAT, also known as lacosamide, is a prominent antiepileptic drug developed by UCB S.A., a global pharmaceutical company. It has been a leader in the epilepsy drugs market for several years, and its market performance is closely tied to the overall dynamics of the epilepsy treatment sector.

Market Leadership

VIMPAT has been the undisputed leading drug in the global epilepsy drugs market. As of 2016, it held a market share of nearly 22%, making it the most dominant player in this segment[1].

Product Approvals and Indications

VIMPAT has received several key approvals that have expanded its market reach. For instance, in November 2020, the U.S. FDA approved VIMPAT (lacosamide) CV as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older. Additionally, VIMPAT injection was approved for intravenous use in children four years of age and older[4].

Financial Performance

The financial performance of VIMPAT has been robust, contributing significantly to UCB's revenue. In 2020, despite the challenges posed by the COVID-19 pandemic, UCB's revenue, driven in part by VIMPAT, increased by 9% to €5.3 billion[5].

Growth Drivers

Several factors have driven the growth of VIMPAT:

• Increasing R&D Investment: Continuous investment in research and development has led to the launch of extended-release formulations, which have further fueled the market growth of VIMPAT[1].
• Strong Product Portfolio: UCB's resilient product portfolio, with VIMPAT as a key component, has helped the company sustain growth even during challenging times[5].
• Expanding Indications: The approval of VIMPAT for additional indications has expanded its market potential, allowing it to reach more patients and increase its revenue[4].

Challenges

Despite its strong market position, VIMPAT faces several challenges:

• Loss of Exclusivity: The loss of exclusivity for VIMPAT in the U.S. and Europe has impacted its sales. This is evident from UCB's financial reports, which show that the known effects of losing exclusivity for VIMPAT and other drugs have offset some of the growth from new product launches[3].
• High Cost of Patented Drugs: The high cost of patented drugs like VIMPAT can restrict market growth, especially in regions with government austerity measures or in low and middle-income countries where accessibility is a significant issue[1].
• Side Effects: Like other epilepsy drugs, VIMPAT can have side effects such as drowsiness, fatigue, and gastrointestinal symptoms, which can hinder its adoption and market growth[4].

Competitive Landscape

VIMPAT operates in a competitive market with other prominent antiepileptic drugs:

• Keppra: Although Keppra was the second-highest market share holder in 2016, its market share was expected to decline due to patent expiration in 2018[1].
• Lamictal: Lamictal is expected to become the second-leading drug in the epilepsy market by 2032, posing a potential challenge to VIMPAT's dominance[1].
• Onfi and Depakine: These drugs also hold significant market shares and are competitors to VIMPAT in the epilepsy treatment market[1].

Regional Performance

The demand for VIMPAT varies by region:

• North America: This region is expected to witness the highest growth in terms of revenue due to the rise in prevalence of epilepsy and the presence of major key players[4].
• Asia-Pacific: This region is anticipated to witness notable growth due to rising healthcare awareness and an increase in the incidence of epilepsy[4].

Future Outlook

Despite the challenges, VIMPAT is expected to continue its growth trajectory:

• UCB's Growth Strategy: UCB is on a growth path for over a decade, with a financial guidance for 2024 foreseeing a growing top line and an almost stable adjusted EBITDA margin. This strategy includes continued investment in product launches and R&D, which will likely benefit VIMPAT[3].
• Market Expansion: The increasing awareness about the importance of early diagnosis and treatment of epilepsy, along with the rise in the ageing population, is expected to offer profitable opportunities for the expansion of the market for VIMPAT[4].

"UCB is on our way to deliver growth for a decade plus. Our financial guidance for 2024 foresees a growing top line and an almost stable adjusted EBITDA margin," - UCB Press Release[3].

Key Takeaways

• VIMPAT is the leading drug in the global epilepsy drugs market with a significant market share.
• The drug has received key approvals that have expanded its indications and market reach.
• Despite challenges such as loss of exclusivity and high costs, VIMPAT is expected to continue its growth driven by UCB's robust R&D and market expansion strategies.
• Regional demand varies, with North America and Asia-Pacific being key growth areas.

FAQs

Q: What is VIMPAT, and what is its role in the epilepsy drugs market? A: VIMPAT, or lacosamide, is a leading antiepileptic drug developed by UCB S.A. It holds a significant market share in the global epilepsy drugs market.

Q: What are the key approvals for VIMPAT? A: VIMPAT has been approved by the U.S. FDA as adjunctive therapy for primary generalized tonic-clonic seizures (PGTCS) and for intravenous use in children four years of age and older.

Q: How has the loss of exclusivity affected VIMPAT's sales? A: The loss of exclusivity for VIMPAT in the U.S. and Europe has impacted its sales, offsetting some of the growth from new product launches.

Q: What are the main challenges facing VIMPAT in the market? A: The main challenges include the high cost of patented drugs, side effects, and the loss of exclusivity.

Q: What is the future outlook for VIMPAT? A: Despite challenges, VIMPAT is expected to continue growing due to UCB's robust R&D and market expansion strategies, along with increasing awareness and demand for epilepsy treatments.

Sources

1. Business Wire: "5.5 Billion Epilepsy Drugs Market: Global Demand, Growth Potential, Opportunity Outlook 2017 - Forecast to 2021 - Research and Markets"
2. PR Newswire: "UCB on Growth Path for a Decade Plus"
3. UCB: "UCB on Growth Path for a Decade Plus"
4. Allied Market Research: "Epilepsy Drugs Market Size, Share & Growth Report, 2032"
5. PR Newswire: "UCB Full Year Report 2020: UCB - sustaining growth, now and into the future"