VIMPAT Drug Patent Profile
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Which patents cover Vimpat, and what generic alternatives are available?
Vimpat is a drug marketed by Ucb Inc and is included in three NDAs. There is one patent protecting this drug and three Paragraph IV challenges.
This drug has twenty-two patent family members in eleven countries.
The generic ingredient in VIMPAT is lacosamide. There are twenty-two drug master file entries for this compound. Thirty-two 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 PHARMS on March 17th, 2022.
Summary for VIMPAT
| International Patents: | 22 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 51 |
| Patent Applications: | 2,415 |
| Formulation / Manufacturing: | see details |
| 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 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 1 |
Pharmacology for VIMPAT
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for VIMPAT
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 seven US patents and three FDA Regulatory Exclusivities.
Patents protecting VIMPAT
Anticonvulsant enantiomeric amino acid derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING, AS INITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL ONSET-SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER WHEN ORAL ADMINISTRATION IS TEMPORARILY NOT FEASIBLE
Anticonvulsant enantiomeric amino acid derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USE OF TREATING, AS AN INITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE THERAPY IN PARTIAL ONSET SEIZURE PATIENTS WITH EPILEPSY AGED 17 YEARS OR OLDER
Anticonvulsant enantiomeric amino acid derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
Anticonvulsant enantiomeric amino acid derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USE FOR TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
Anticonvulsant enantiomeric amino acid derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING, AS MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS AND OLDER WHEN ORAL ADMINISTRATION IS TEMPORARILY NOT FEASIBLE
Anticonvulsant enantiomeric amino acid derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PARTIAL ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
Anticonvulsant enantiomeric amino acid derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING, AS INITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL ONSET-SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER
FDA Regulatory Exclusivity protecting VIMPAT
ADDITION OF A NEW INDICATION FOR ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Try a Trial
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
| 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 | TABLET;ORAL | 022253-002 | Oct 28, 2008 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-002 | Oct 28, 2008 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Ucb Inc | VIMPAT | lacosamide | SOLUTION;INTRAVENOUS | 022254-001 | Oct 28, 2008 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | |
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-003 | Oct 28, 2008 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Ucb Inc | VIMPAT | lacosamide | SOLUTION;INTRAVENOUS | 022254-001 | Oct 28, 2008 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-003 | Oct 28, 2008 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | |
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ucb Inc | VIMPAT | lacosamide | SOLUTION;ORAL | 022255-001 | Apr 20, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ucb Inc | VIMPAT | lacosamide | SOLUTION;INTRAVENOUS | 022254-001 | Oct 28, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-001 | Oct 28, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-002 | Oct 28, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-004 | Oct 28, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Australia | 596573 | ⤷ Try a Trial | |
| Japan | S63132832 | ANTICONVULSIVANT OF AMINO ACID DERIVATIVE | ⤷ Try a Trial |
| Australia | 718577 | ⤷ Try a Trial | |
| Canada | 2248317 | DERIVES AMINOACIDES ENANTIOMERIQUES AYANT UN EFFET ANTI-CONVULSIF (ANTICONVULSANT ENANTIOMERIC AMINO ACID DERIVATIVES) | ⤷ Try a Trial |
| Germany | 3678469 | ⤷ Try a Trial | |
| Canada | 1340904 | COMPOSE ANTICONVULSIF A BASE D'UN DERIVE D'ACIDE AMINE (AMINO ACID DERIVATIVE ANTICONVULSANT) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIMPAT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0888289 | 09C0006 | France | ⤷ Try a Trial | 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 | CA 2009 00001 | Denmark | ⤷ Try a Trial | |
| 0888289 | C00888289/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009 |
| 0888289 | C300376 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829 |
| 0888289 | SPC001/2009 | Ireland | ⤷ Try a Trial | SPC001/2009: 20091013, EXPIRES: 20220316 |
| 0888289 | SPC/GB09/007 | United Kingdom | ⤷ Try a Trial | 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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