VIMPAT Drug Patent Profile
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Which patents cover Vimpat, 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-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 17th, 2022.
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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 |
|---|---|
| Beijing Capton Pharmaceutical Technology Development Co., LTD | Phase 1 |
| Overseas Pharmaceuticals, 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 | |||
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-004 | Oct 28, 2008 | AB | 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 | 022253-001 | Oct 28, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| 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 | 022253-001 | 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 | |
| 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 | |
| >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 |
|---|---|---|---|
| Japan | 3145414 | ⤷ Sign Up | |
| Spain | 552348 | ⤷ Sign Up | |
| New Zealand | 233728 | AMINO ACID COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF | ⤷ Sign Up |
| Portugal | 94103 | PROCESSO PARA A PREPARACAO DE AGENTES ANTICONVULSIVOS A BASE DE DERIVADOS AMINO-ACIDOS | ⤷ 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 | 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 |
| 0888289 | C300376 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829 |
| 0888289 | SPC/GB09/007 | United Kingdom | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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