DrugPatentWatch Database Preview
VIMPAT Drug Profile
Email this page to a colleague
» See Plans and PricingWhich 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. Three suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
US ANDA Litigation and Generic Entry Outlook for Vimpat
Vimpat was eligible for patent challenges on October 28, 2012.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 17, 2022. This may change due to patent challenges or generic licensing.
There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are seven tentative approvals for the generic drug (lacosamide), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for VIMPAT
| International Patents: | 22 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 3 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 78 |
| Clinical Trials: | 49 |
| Patent Applications: | 822 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VIMPAT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VIMPAT |
| DailyMed Link: | VIMPAT at DailyMed |
Generic Entry Opportunity Date for VIMPAT
Generic Entry Dates for VIMPAT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
Generic Entry Dates for VIMPAT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;ORAL |
Generic Entry Dates for VIMPAT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for VIMPAT
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Paragraph IV (Patent) Challenges for VIMPAT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VIMPAT | SOLUTION;INTRAVENOUS | lacosamide | 022254 | 2016-06-30 |
| VIMPAT | TABLET;ORAL | lacosamide | 022253 | 2012-10-29 |
| VIMPAT | SOLUTION;ORAL | lacosamide | 022255 | 2012-10-29 |
US Patents and Regulatory Information for VIMPAT
| 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 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-004 | Oct 28, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-001 | Oct 28, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ucb Inc | VIMPAT | lacosamide | SOLUTION;ORAL | 022255-001 | Apr 20, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-002 | Oct 28, 2008 | RX | Yes | No | Start Trial | Start Trial | Start 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 | 022253-001 | Oct 28, 2008 | Start Trial | Start Trial |
| Ucb Inc | VIMPAT | lacosamide | SOLUTION;INTRAVENOUS | 022254-001 | Oct 28, 2008 | Start Trial | Start Trial |
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-004 | Oct 28, 2008 | Start Trial | Start Trial |
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-002 | Oct 28, 2008 | Start Trial | Start Trial |
| Ucb Inc | VIMPAT | lacosamide | SOLUTION;ORAL | 022255-001 | Apr 20, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIMPAT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | H06510985 | Start Trial |
| Austria | 268169 | Start Trial |
| Japan | 2000505476 | Start Trial |
| Germany | 69729392 | Start Trial |
| Portugal | 1038522 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VIMPAT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0888289 | 09C0006 | France | Start 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 | SPC001/2009 | Ireland | Start Trial | SPC001/2009: 20091013, EXPIRES: 20220316 |
| 0888289 | SPC/GB09/007 | United Kingdom | Start 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 |
| 0888289 | CA 2009 00001 | Denmark | Start Trial | |
| 0888289 | C00888289/01 | Switzerland | Start Trial | PRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
