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Lacosamide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for lacosamide?

Lacosamide is the generic ingredient in two branded drugs marketed by Msn Labs Pvt Ltd, Mylan Pharms Inc, Sun Pharma Global, Amneal Pharms, Ucb Inc, Actavis Labs Fl Inc, Alembic Pharms Ltd, and Aurobindo Pharma Ltd, and is included in eleven NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lacosamide has nineteen patent family members in eleven countries.

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

Summary for Generic Name: lacosamide

Tradenames:2
Patents:2
Applicants:8
NDAs:11
Drug Master File Entries: see list21
Suppliers / Packagers: see list6
Bulk Api Vendors: see list60
Clinical Trials: see list63
Patent Applications: see list976
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lacosamide at DailyMed

Pharmacology for Ingredient: lacosamide

Tentative approvals for LACOSAMIDE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET;ORAL200MG
► Subscribe► SubscribeSOLUTION;ORAL10MG/ML
► Subscribe► SubscribeTABLET;ORAL200MG
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
TABLET;ORAL022253-001Oct 28, 2008RXYesNoRE38551► SubscribeYY ► Subscribe
Ucb Inc
VIMPAT
lacosamide
TABLET;ORAL022253-002Oct 28, 2008RXYesNoRE38551► SubscribeYY ► Subscribe
Sun Pharma Global
LACOSAMIDE
lacosamide
TABLET;ORAL205031-003Apr 28, 2016RXNoNo► Subscribe► Subscribe
Amneal Pharms
LACOSAMIDE
lacosamide
TABLET;ORAL204857-003Sep 9, 2016RXNoNo► Subscribe► Subscribe
Amneal Pharms
LACOSAMIDE
lacosamide
TABLET;ORAL204857-002Sep 9, 2016RXNoNo► Subscribe► 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 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;INTRAVENOUS022254-001Oct 28, 20085,654,301► Subscribe
Ucb Inc
VIMPAT
lacosamide
TABLET;ORAL022253-002Oct 28, 20085,654,301► Subscribe
Ucb Inc
VIMPAT
lacosamide
TABLET;ORAL022253-003Oct 28, 20085,654,301► 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
Denmark0888289► Subscribe
Germany69705210► Subscribe
Austria202079► Subscribe
European Patent Office0888289► Subscribe
Australia718577► 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
0888289/01Switzerland► SubscribePRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009
00376Netherlands► SubscribePRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829
C001/2009Ireland► SubscribeSPC001/2009: 20091013, EXPIRES: 20220316
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
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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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