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VIMPAT Drug Profile

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Which patents cover Vimpat, and what substitute generic drugs 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 nineteen patent family members in eleven countries.

The generic ingredient in VIMPAT is lacosamide. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the lacosamide profile page.

Summary for Tradename: VIMPAT

Patents:1
Applicants:1
NDAs:3
Suppliers / Packagers: see list3
Bulk Api Vendors: see list61
Clinical Trials: see list46
Patent Applications: see list517
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:VIMPAT at DailyMed

Pharmacology for Tradename: VIMPAT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ucb Inc
VIMPAT
lacosamide
SOLUTION;ORAL022255-001Apr 20, 2010RXYesYes► Subscribe► Subscribe
Ucb Inc
VIMPAT
lacosamide
TABLET;ORAL022253-001Oct 28, 2008RXYesNoRE38551► SubscribeYY ► Subscribe
Ucb Inc
VIMPAT
lacosamide
TABLET;ORAL022253-004Oct 28, 2008RXYesYes► Subscribe► Subscribe
Ucb Inc
VIMPAT
lacosamide
TABLET;ORAL022253-002Oct 28, 2008RXYesNo► Subscribe► Subscribe
Ucb Inc
VIMPAT
lacosamide
TABLET;ORAL022253-004Oct 28, 2008RXYesYesRE38551► SubscribeYY ► Subscribe
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Expired Patents for Tradename: VIMPAT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc
VIMPAT
lacosamide
SOLUTION;INTRAVENOUS022254-001Oct 28, 20085,654,301► Subscribe
Ucb Inc
VIMPAT
lacosamide
TABLET;ORAL022253-003Oct 28, 20085,654,301► Subscribe
Ucb Inc
VIMPAT
lacosamide
TABLET;ORAL022253-004Oct 28, 20085,654,301► Subscribe
Ucb Inc
VIMPAT
lacosamide
TABLET;ORAL022253-001Oct 28, 20085,654,301► Subscribe
Ucb Inc
VIMPAT
lacosamide
SOLUTION;ORAL022255-001Apr 20, 20105,654,301► Subscribe
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Paragraph IV activity for: VIMPAT

Drugname Dosage Strength RLD Submissiondate
lacosamide Injection10 mg/mL, 20 mLVimpat 6/30/2016
lacosamideOral Solution10 mg/mLVimpat10/29/2012
lacosamideTablets50 mg, 100 mg, 150 mg, and 200 mgVimpat10/29/2012

Non-Orange Book Patents for Tradename: VIMPAT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,773,475 Anticonvulsant enantiomeric amino acid derivatives► Subscribe
6,048,899 Anticonvulsant enantiomeric amino acid derivatives► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: VIMPAT

Country Document Number Estimated Expiration
Spain2157567► Subscribe
Germany122009000010► Subscribe
Austria202079► Subscribe
Portugal888289► Subscribe
World Intellectual Property Organization (WIPO)9733861► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: VIMPAT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009 00001Denmark► Subscribe
00376Netherlands► SubscribePRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
0888289/01Switzerland► SubscribePRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009
C/GB09/007United Kingdom► SubscribePRODUCT 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
C001/2009Ireland► SubscribeSPC001/2009: 20091013, EXPIRES: 20220316
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