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Lacosamide - Generic Drug Details

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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 is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has nineteen patent family members in eleven countries.

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

Summary for Generic Name: lacosamide

Tradenames:2
Patents:1
Applicants:8
NDAs:11
Drug Master File Entries: see list21
Suppliers / Packaging: see list5
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: lacosamide

Tentative approvals for LACOSAMIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL200MG
<disabled><disabled>SOLUTION;ORAL10MG/ML
<disabled><disabled>TABLET;ORAL50MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic Pharms Ltd
LACOSAMIDE
lacosamide
TABLET;ORAL204974-004Apr 28, 2016RXNo► subscribe► subscribe
Actavis Labs Fl Inc
LACOSAMIDE
lacosamide
TABLET;ORAL204855-004Apr 28, 2016RXNo► subscribe► subscribe
Sun Pharma Global
LACOSAMIDE
lacosamide
TABLET;ORAL205031-002Apr 28, 2016RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: lacosamide

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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;ORAL022253-002Oct 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
6,048,899 Anticonvulsant enantiomeric amino acid derivatives► subscribe
5,773,475 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
Germany69705210► subscribe
Japan2000505476► 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: LACOSAMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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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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