VIMPAT Drug Patent Profile

Which patents cover Vimpat, 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-eight 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:	2,544
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
Indiana University	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

Expired US Patents for VIMPAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-004	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-001	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008

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

International Patents for VIMPAT

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

Country	Patent Number	Title	Estimated Expiration
Austria	161824
Austria	214384
Austria	62222

Supplementary Protection Certificates for VIMPAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0888289	CA 2009 00001	Denmark
0888289	SPC001/2009	Ireland		SPC001/2009: 20091013, EXPIRES: 20220316
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

Vimpat (lacosamide) market dynamics and financial trajectory: pricing, volume drivers, competition, and IP-driven risk

Last updated: July 19, 2026

Executive summary: Lacosamide (brand Vimpat; UCB) is a mature US and EU specialty anti-seizure market with ongoing demand from partial-onset seizures (focal seizures). The sales trajectory is primarily driven by (1) penetration in neurology formularies, (2) channel inventory cycles, (3) geographic mix, and (4) patent and exclusivity milestones affecting generic/authorized competition. Commercial risk is concentrated in major markets where lacosamide’s first wave of product exclusivity has aged out, shifting growth to share retention, pricing, and contracting rather than new protected product launches.

What is Vimpat (lacosamide) and what conditions drive demand?

Vimpat is the brand name for lacosamide, an anti-seizure medicine used in focal (partial-onset) seizures:

• Adults: adjunctive therapy for partial-onset seizures with or without secondary generalization
• Pediatric patients: adjunctive therapy for partial-onset seizures in appropriate age cohorts (labeling varies by jurisdiction)

Demand is influenced by neurologist prescribing patterns, pediatric uptake, and payer approval for add-on therapy in epilepsy patients inadequately controlled on existing regimens.

Which patient segments matter most commercially

• Refractory focal epilepsy requiring add-on therapy
• Pediatric focal seizures where formulary placement and utilization management can accelerate or slow uptake
• Switching dynamics: add-on positioning supports substitution between branded and generic lacosamide depending on contracts and copay dynamics

How big is the lacosamide/Vimpat market and what are the key growth levers?

Growth levers for a mature anti-epileptic include:

• Formulary access: preferred status in managed care plans
• Reimbursement and net price: rebates and contracting shape the effective revenue trajectory even when unit demand holds
• Channel inventory: distributor stocking and de-stocking cycles that can swing reported revenue
• Prescriber behavior: inertia favors stable brands or low-cost generics depending on local dynamics
• Authorized generics and generic entry timing: tends to compress price while keeping volume stable

Mature-market reality: For lacosamide, the financial trajectory typically becomes less about “new product adoption curves” and more about share under price pressure and reductions in average selling price (ASP) after generic competition.

What patent and exclusivity dynamics affect Vimpat revenue?

Brand economics in mature products hinge on when meaningful exclusivity barriers fall, including:

• Primary composition-of-matter expiration
• Orphan or pediatric exclusivity (if applicable)
• Supplemental protection from formulation, dosing regimen, and method-of-use patents
• Regulatory exclusivities and patent listings that sustain “first filer” litigation leverage

How long does Vimpat keep exclusivity and when does it lose exclusivity?

For mature brands like Vimpat, exclusivity is usually segmented into:

1. Regulatory exclusivity windows tied to first approval or other statutory exclusivities
2. Patent estate coverage through listed patents in the Orange Book
3. Practical exclusivity influenced by litigation, settlements, and launch design around active patent claims

In practice, once the major Orange Book barriers erode, generics launch and revenue shifts from brand margin to volume-based net revenue.

What patents protect lacosamide products and how do formulation patents change the story?

Commercial impact from patent “second waves” typically comes from:

• Formulation and dosage form patents (e.g., specific tablets or release characteristics)
• Method-of-use patents (new dosing regimens or indications can extend exclusivity indirectly)
• Manufacturing process patents that can constrain launch readiness

For Vimpat, the revenue relevance is that late-expiring supplemental patents can delay or narrow generic entry, particularly for specific strengths or labeled populations.

How does generic entry risk affect Vimpat pricing and unit sales?

Generic entry risk generally produces three observable effects:

1. ASP compression: branded net prices fall as payers and channels push lower-cost options
2. Share shift: volume migrates from brand to generic lacosamide
3. Mix effects: remaining branded share may concentrate in higher-acuity or less price-sensitive channels if formulary tiers vary

What generic launch scenarios exist for lacosamide?

Launch scenarios commonly differ by:

• Strength-by-strength readiness (availability of all tablet strengths simultaneously)
• Label alignment (adjunctive therapy language and pediatric indications)
• Portfolio bundling: substitution at the pharmacy can depend on which generic NDCs are contracted
• Litigation outcomes: if a Paragraph IV challenge is settled with a delayed launch date, competition enters in a phased manner

What Paragraph IV challenges and patent litigation affect Vimpat?

When Paragraph IV filings occur against Orange Book-listed patents, outcomes usually determine:

• Whether generic approval converts into market entry
• Launch timing and potential “at-risk” periods
• Settlement-based workarounds that shape which strengths enter first

For Vimpat, the key financial linkage is that litigation and settlements determine when price compression accelerates in major markets.

What is the Orange Book status of Vimpat (lacosamide) and what does it mean for investors?

The FDA Orange Book listings determine which patents are tied to the approved drug and can block generic entry. Orange Book status affects:

• First-filer incentives
• Delay or carve-outs in settlement agreements
• Risk of incremental entry even after major exclusivity ends, depending on remaining listed patents

Which patent categories typically matter most in Orange Book practice

• Composition-of-matter
• Formulation
• Method-of-use
• Drug product and process claims that can be triggered by “work-to-infringe” differences

Which companies are competitive in lacosamide and how does Vimpat compare?

Competition in lacosamide usually comes from:

• Generic manufacturers with ANDA products across major dosage strengths
• Authorized generics if the originator uses licensing structures
• Wholesale and pharmacy benefit contracting that favors low net-cost options

How does Vimpat compare with generic lacosamide on a financial basis?

For mature antiepileptics under generic pressure:

• Brand revenue declines as net price resets and share erodes.
• Generic firms capture units but operate on narrower gross margins, which can be offset by volume scale.
• The brand may retain residual share where payers allow brand on higher tiers, or where neurologists prefer a particular formulation.

How do FDA status and approval pathways affect Vimpat’s financial trajectory?

Vimpat’s FDA regulatory position affects competitive rhythm:

• Generic approvals under ANDA typically lead to early supply availability and quick share shift post-entry.
• Any label expansions can temporarily bolster demand, but in mature products the dominant effect remains competitive pricing.

What regulatory events would move sales for Vimpat

• Pediatric label updates that change utilization management criteria
• REMS changes or safety communication that influence prescribing
• Market-level shortages or supply disruptions that affect the share of available product

What commercial metrics indicate Vimpat momentum or deterioration?

Financial trajectory in mature products is best read from:

• US and EU net sales trends (quarterly seasonality is common in chronic therapies)
• ASP declines as generic penetrates
• Script volume changes that separate demand from pricing
• Inventory movements in wholesalers and specialty distributors
• Formulary placement changes (tiering, prior authorization, step edits)

How do contracting and pricing dynamics shape net revenue even when demand is stable?

Even without volume collapse, net revenue can fall through:

• Increased rebate pressure
• Higher generic substitution in PBM formularies
• Retail switching and mail order volume shifts
• Competitive contracting that sets brand net pricing near generic parity

For mature therapies like lacosamide, most net revenue declines are typically driven by net price and mix, not immediate demand loss.

What is the likely financial trajectory under ongoing competition for Vimpat?

Base case dynamic for mature lacosamide products:

• Continued unit demand stability from chronic use
• Persistent pricing decline as competition deepens
• Brand share erosion until it stabilizes at a residual level driven by payer preferences, patient-specific considerations, and channel mix

The net revenue “slope” becomes flatter after the initial wave of competition, but margin compression remains structural unless the originator regains preferential contracting or differentiates through product lifecycle tactics (e.g., patient support tied to brand).

Key timeline: IP and competitive inflection points that typically drive Vimpat’s financial swings

The financial record of originator anti-epileptics under generic pressure usually clusters into:

• Pre-launch period: stable brand share, minor price concessions
• Generic launch window: abrupt ASP drop and share transition
• Post-launch stabilization: volume settles; net price continues to drift down gradually
• Remaining-patent effects: slower entry or strength-specific delays can create temporary pacing changes

Key takeaways

• Vimpat (lacosamide) is a mature anti-seizure franchise where net revenue trajectory is dominated by pricing and share changes after generic entry, not by early-cycle adoption.
• The primary financial inflection points come from Orange Book patent status, Paragraph IV litigation outcomes, and settlement-triggered launch timing.
• Commercial momentum is most sensitive to formulary access and contracting, which can swing net price even if script demand remains stable.
• Over the medium term, the base-case path is unit durability with sustained ASP compression, with upside only from improved contracting or label-driven demand changes.

FAQs

1. When do lacosamide generics typically trigger large ASP drops after Orange Book barriers fall?
2. How do payer formularies and step edits change lacosamide brand-to-generic switching speed?
3. Do pediatric focal seizure indications materially extend Vimpat’s revenue curve?
4. What do settlement agreements in ANDA Paragraph IV cases usually mean for launch timing by dosage strength?
5. How does supply availability or shortage of lacosamide affect brand and generic revenue shares?

References

1. FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. FDA. Drugs@FDA: Vimpat (lacosamide). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

DrugChatter Q&A for VIMPAT

Expiration date of vimpat?
Vimpat product tracker update us and russia?
Vimpat loss of exclusivity?
Vimpat regulatory designations?
Is branded vimpat still being made?