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Serving leading biopharmaceutical companies globally:

Farmers Insurance
AstraZeneca
Baxter
Colorcon
UBS
Dow
Johnson and Johnson
Cipla
US Army
Express Scripts

Generated: December 11, 2017

DrugPatentWatch Database Preview

LACOSAMIDE - Generic Drug Details

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What are the generic drug sources for lacosamide and what is the scope of lacosamide patent protection?

Lacosamide
is the generic ingredient in one branded drug marketed by Ucb Inc and is included in three NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lacosamide has twenty-two patent family members in eleven countries and six supplementary protection certificates in six countries.

There are twenty-one drug master file entries for lacosamide. Three suppliers are listed for this compound. There are four tentative approvals for this compound.

Pharmacology for LACOSAMIDE

Tentative approvals for LACOSAMIDE

Applicant Application No. Strength Dosage Form
u► Subscribe10MG/MLSOLUTION;ORAL
u► Subscribe200MGTABLET;ORAL
u► Subscribe150MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Ucb IncVIMPATlacosamideTABLET;ORAL022253-004Oct 28, 2008RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Ucb IncVIMPATlacosamideSOLUTION;INTRAVENOUS022254-001Oct 28, 2008RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Ucb IncVIMPATlacosamideTABLET;ORAL022253-004Oct 28, 2008RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Ucb IncVIMPATlacosamideTABLET;ORAL022253-002Oct 28, 2008RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Ucb IncVIMPATlacosamideTABLET;ORAL022253-001Oct 28, 2008RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Ucb IncVIMPATlacosamideTABLET;ORAL022253-002Oct 28, 2008RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Ucb IncVIMPATlacosamideTABLET;ORAL022253-003Oct 28, 2008RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Ucb IncVIMPATlacosamideTABLET;ORAL022253-001Oct 28, 2008RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Ucb IncVIMPATlacosamideSOLUTION;INTRAVENOUS022254-001Oct 28, 2008RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Ucb IncVIMPATlacosamideTABLET;ORAL022253-003Oct 28, 2008RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: lacosamide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb IncVIMPATlacosamideTABLET;ORAL022253-003Oct 28, 2008► Subscribe► Subscribe
Ucb IncVIMPATlacosamideSOLUTION;INTRAVENOUS022254-001Oct 28, 2008► Subscribe► Subscribe
Ucb IncVIMPATlacosamideSOLUTION;ORAL022255-001Apr 20, 2010► Subscribe► Subscribe
Ucb IncVIMPATlacosamideTABLET;ORAL022253-004Oct 28, 2008► Subscribe► Subscribe
Ucb IncVIMPATlacosamideTABLET;ORAL022253-001Oct 28, 2008► Subscribe► Subscribe
Ucb IncVIMPATlacosamideTABLET;ORAL022253-002Oct 28, 2008► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: lacosamide

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 Ingredient: lacosamide

Country Document Number Estimated Expiration
Portugal1038522► Subscribe
Austria202079► Subscribe
World Intellectual Property Organization (WIPO)0000463► Subscribe
Germany69705210► Subscribe
Netherlands300376► Subscribe
World Intellectual Property Organization (WIPO)9733861► Subscribe
European Patent Office1038522► Subscribe
Denmark1038522► Subscribe
European Patent Office0888289► Subscribe
Germany69729392► 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: LACOSAMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009 00001Denmark► Subscribe
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
C0006France► SubscribePRODUCT 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
0888289/01Switzerland► SubscribePRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009
C001/2009Ireland► SubscribeSPC001/2009: 20091013, EXPIRES: 20220316
00376Netherlands► SubscribePRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
QuintilesIMS
Queensland Health
Healthtrust
McKesson
Colorcon
Cantor Fitzgerald
Deloitte
US Army

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 verifification 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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