VIMPAT Drug Patent Profile
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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. Forty-four 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 17th, 2022.
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Questions you can ask:
- What is the 5 year forecast for VIMPAT?
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- What is Average Wholesale Price for VIMPAT?
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: | 1,797 |
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 |
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 |
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.
FDA Regulatory Exclusivity protecting VIMPAT
USE OF ALTERNATE INITIAL DOSING REGIMEN FOR INITIATION OF LACOSAMIDE TREATMENT IN PARTIAL ONSET SEIZURE PATIENTS ≥1 MONTH TO
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-002 | Oct 28, 2008 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ucb Inc | VIMPAT | lacosamide | SOLUTION;ORAL | 022255-001 | Apr 20, 2010 | AA | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VIMPAT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-002 | Oct 28, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Ucb Inc | VIMPAT | lacosamide | SOLUTION;INTRAVENOUS | 022254-001 | Oct 28, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-003 | Oct 28, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for VIMPAT
See the table below for patents covering VIMPAT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 1340902 | COMPOSE ANTICONVULSIF A BASE D'UN DERIVE D'ACIDE AMINE (AMINO ACID DERIVATIVE ANTICONVULSANT) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 9221648 | ⤷ Sign Up | |
Austria | 202079 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIMPAT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0888289 | C300376 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829 |
0888289 | CA 2009 00001 | Denmark | ⤷ Sign Up | |
0888289 | 09C0006 | France | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |