Vimpat is a drug owned by Ucb Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Vimpat's patents have been open to challenges since 28 October, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 28, 2026. Details of Vimpat's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| USRE38551 | Anticonvulsant enantiomeric amino acid derivatives |
Mar, 2022
(3 years ago) |
Expired
|
| US5654301 | Amino acid derivative anticonvulsant |
Aug, 2014
(10 years ago) |
Expired
|
FDA has granted several exclusivities to Vimpat. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vimpat, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Vimpat.
Exclusivity Information
Vimpat holds 8 exclusivities out of which 7 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Vimpat's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 28, 2013 |
| New Dosing Schedule(D-143) | Aug 29, 2017 |
| New Dosing Schedule(D-144) | Aug 29, 2017 |
| New Indication(I-696) | Aug 29, 2017 |
| M(M-217) | Nov 03, 2020 |
| New Indication(I-878) | Nov 16, 2023 |
| New Patient Population(NPP) | Oct 14, 2024 |
| New Dosing Schedule(D-188) | Apr 28, 2026 |
US patents provide insights into the exclusivity only within the United States, but Vimpat is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Vimpat's family patents as well as insights into ongoing legal events on those patents.
Vimpat's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vimpat's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 28, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vimpat Generic API suppliers:
Lacosamide is the generic name for the brand Vimpat. 31 different companies have already filed for the generic of Vimpat, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vimpat's generic
How can I launch a generic of Vimpat before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vimpat's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vimpat's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Vimpat -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/mL | 29 Oct, 2012 | 3 | 17 Mar, 2022 | Extinguished | |
| 50 mg, 100 mg, 150 mg, and 200 mg | 29 Oct, 2012 | 14 | 17 Mar, 2022 | 17 Mar, 2022 | Extinguished |
| 10 mg/mL, 20 mL | 30 Jun, 2016 | 1 | 17 Mar, 2022 | Extinguished |
Alternative Brands for Vimpat
Vimpat which is used for treating partial-onset seizures in patients with epilepsy aged 17 years and older, either as adjunctive therapy or when oral treatment is temporarily not feasible., has several other brand drugs using the same active ingredient (Lacosamide). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Aucta |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Lacosamide, Vimpat's active ingredient. Check the complete list of approved generic manufacturers for Vimpat
About Vimpat
Vimpat is a drug owned by Ucb Inc. It is used for treating partial-onset seizures in patients with epilepsy aged 17 years and older, either as adjunctive therapy or when oral treatment is temporarily not feasible. Vimpat uses Lacosamide as an active ingredient. Vimpat was launched by Ucb Inc in 2008.
Approval Date:
Vimpat was approved by FDA for market use on 28 October, 2008.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Vimpat is 28 October, 2008, its NCE-1 date is estimated to be 28 October, 2012.
Active Ingredient:
Vimpat uses Lacosamide as the active ingredient. Check out other Drugs and Companies using Lacosamide ingredient
Treatment:
Vimpat is used for treating partial-onset seizures in patients with epilepsy aged 17 years and older, either as adjunctive therapy or when oral treatment is temporarily not feasible.
Dosage:
Vimpat is available in the following dosage forms - solution form for oral use, solution form for intravenous use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG/20ML (10MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 200MG | TABLET | Prescription | ORAL |
| 150MG | TABLET | Prescription | ORAL |
| 10MG/ML | SOLUTION | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |
| 100MG | TABLET | Prescription | ORAL |