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Generated: July 27, 2017
What are the generic drug sources for lacosamide and what is the scope of lacosamide freedom to operate?
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.| Tradenames: | 2 |
| Patents: | 1 |
| Applicants: | 8 |
| NDAs: | 11 |
| Drug Master File Entries: see list | 21 |
| Suppliers / Packagers: see list | 6 |
| Bulk Api Vendors: see list | 60 |
| Clinical Trials: see list | 77 |
| Patent Applications: see list | 976 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | lacosamide at DailyMed |
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 10MG/ML | SOLUTION;ORAL |
| ► Subscribe | ► Subscribe | 200MG | TABLET;ORAL |
| ► Subscribe | ► Subscribe | 150MG | TABLET;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharma Global | LACOSAMIDE | lacosamide | TABLET;ORAL | 205031-002 | Apr 28, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Alembic Pharms Ltd | LACOSAMIDE | lacosamide | TABLET;ORAL | 204974-003 | Apr 28, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Sun Pharma Global | LACOSAMIDE | lacosamide | TABLET;ORAL | 205031-003 | Apr 28, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Ucb Inc | VIMPAT | lacosamide | SOLUTION;INTRAVENOUS | 022254-001 | Oct 28, 2008 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-003 | Oct 28, 2008 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | |||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-002 | Oct 28, 2008 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Ucb Inc | VIMPAT | lacosamide | SOLUTION;INTRAVENOUS | 022254-001 | Oct 28, 2008 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-003 | Oct 28, 2008 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-001 | Oct 28, 2008 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Ucb Inc | VIMPAT | lacosamide | SOLUTION;ORAL | 022255-001 | Apr 20, 2010 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Germany | 69705210 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2000505476 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 3145414 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 69729392 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 122009000010 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00376 | Netherlands | ► Subscribe | PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829 | ||||||||||||||||||||||||||
| C/GB09/007 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
| C001/2009 | Ireland | ► Subscribe | SPC001/2009: 20091013, EXPIRES: 20220316 | ||||||||||||||||||||||||||
| C0006 | France | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 0888289/01 | Switzerland | ► Subscribe | PRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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