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Lacosamide - Generic Drug Details
What are the generic drug sources for lacosamide and what is the scope of freedom to operate?
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.
There are twenty-two drug master file entries for lacosamide. Three suppliers are listed for this compound. There are seven tentative approvals for this compound.
Summary for lacosamide
| International Patents: | 22 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 3 |
| Drug Master File Entries: | 22 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 76 |
| Clinical Trials: | 86 |
| Patent Applications: | 1,355 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lacosamide |
| DailyMed Link: | lacosamide at DailyMed |
Recent Clinical Trials for lacosamide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Danish Pain Research Center | Phase 2 |
| Odense University Hospital | Phase 2 |
| Duke University | Phase 2 |
Recent Litigation for lacosamide
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd. | 2017-05-31 |
| UCB, Inc. v. Hetero USA Inc. | 2016-06-17 |
| UCB Inc. v. Glenmark Generics Inc. USA | 2013-07-10 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals Inc. | 2016-06-23 |
| Alembic Pharmaceuticals, Ltd. | 2016-06-22 |
| Breckenridge Phamaceutical, Inc. | 2016-06-21 |
Generic filers with tentative approvals for LACOSAMIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 150MG | TABLET;ORAL |
| Start Trial | Start Trial | 10MG/ML | SOLUTION;ORAL |
| Start Trial | Start Trial | 200MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for lacosamide
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Synonyms for lacosamide
| ( )-(2R)-2-(acetylamino)-N-benzyl-3-methoxypropanamide |
| (2R)-2-(Acetylamino)-N-benzyl-3-methoxypropanamide |
| (2R)-2-(Acetylamino)-N-benzyl-3-methoxypropanamide;Lacosamide |
| (2R)-2-acetamido-3-methoxy-N-(phenylmethyl)propanamide |
| (2R)-2-acetamido-N-benzyl-3-methoxy-propanamide |
| (2R)-2-acetamido-N-benzyl-3-methoxypropanamide |
| (2R)-2-acetylamino-N-benzyl-3-methoxypropanamide |
| (2R)-N-benzyl-2-acetamido-3-methoxypropanamide |
| (R)-2-acetamido-N-benzyl-3-methoxypropanamide |
| (R)-2-acetamido-N-benzyl-3-methoxypropionamide |
| (R)-2-Acetylamino-N-benzyl-3-methoxy-propionamide |
| (R)-2-Acetylamino-N-benzyl-3-methoxypropionamide |
| (R)-N-benzyl 2-acetamido-3-methoxypropionamide |
| (R)-N-benzyl 2-acetamido-3-methoxypropionamide, |
| (R)-N-benzyl-2-acetamido-3-methoxypropanamide |
| (R)-N-Benzyl-2-acetamido-3-methoxypropionamide |
| 175481-36-4 |
| 2-(Acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)- |
| 2-(Acetylamino)-3-methoxy-N-(phenylmethyl)propanamide, (2R)- |
| 481L364 |
| 563KS2PQY5 |
| A3897 |
| AB0020074 |
| AB01559947-01 |
| AB1011880 |
| AC-22750 |
| AC1L560M |
| ADD 234037 |
| ADD 243037 |
| ADD-234037 |
| ADD-243037 |
| AJ-08306 |
| AKOS005146274 |
| AM808141 |
| AN-5196 |
| ANW-58547 |
| BB 0260890 |
| BCP02197 |
| BDBM50300204 |
| CAS-175481-36-4 |
| CHEBI:135939 |
| CHEMBL58323 |
| CJ-00115 |
| CS-0529 |
| CTK8B7781 |
| D07299 |
| DB06218 |
| DEA No. 2746 |
| DSSTox_CID_31455 |
| DSSTox_GSID_57666 |
| DSSTox_RID_97341 |
| DTXSID1057666 |
| EBD27785 |
| Erlosamide |
| Erlosamide [INN] |
| FT-0650739 |
| GTPL7472 |
| harkeroside |
| Harkoseride |
| HY-13015 |
| I01-7424 |
| I14-32137 |
| KS-00000XOQ |
| KS-1227 |
| Lacosamide (JAN/USAN/INN) |
| Lacosamide [USAN:INN:BAN] |
| Lacosamide 1.0 mg/ml in Acetonitrile |
| Lacosamide racemate |
| Lacosamide solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material |
| Lacosamide; Propanamide,2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (R)- |
| LS-185541 |
| M-1600 |
| MFCD08272557 |
| MolPort-006-170-142 |
| NCGC00253740-01 |
| Propanamide, 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)- |
| RL02246 |
| SB18905 |
| SCHEMBL35330 |
| SPM 927 |
| SPM 927; Erlosamide |
| SPM-927 |
| SPM-929 |
| SR-01000942286 |
| SR-01000942286-1 |
| ST24026403 |
| TC-064381 |
| Tox21_113857 |
| UNII-563KS2PQY5 |
| V0815 |
| Vimpat |
| Vimpat (TN) |
| VPPJLAIAVCUEMN-GFCCVEGCSA-N |
| Z1550648754 |
| ZINC7673 |
Paragraph IV (Patent) Challenges for LACOSAMIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VIMPAT | SOLUTION;INTRAVENOUS | lacosamide | 022254 | 2016-06-30 |
| VIMPAT | SOLUTION;ORAL | lacosamide | 022255 | 2012-10-29 |
| VIMPAT | TABLET;ORAL | lacosamide | 022253 | 2012-10-29 |
US Patents and Regulatory Information for lacosamide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-001 | Oct 28, 2008 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Ucb Inc | VIMPAT | lacosamide | SOLUTION;INTRAVENOUS | 022254-001 | Oct 28, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-002 | Oct 28, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-004 | Oct 28, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for lacosamide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-001 | Oct 28, 2008 | Start Trial | Start Trial |
| Ucb Inc | VIMPAT | lacosamide | SOLUTION;INTRAVENOUS | 022254-001 | Oct 28, 2008 | Start Trial | Start Trial |
| Ucb Inc | VIMPAT | lacosamide | SOLUTION;ORAL | 022255-001 | Apr 20, 2010 | Start Trial | Start Trial |
| Ucb Inc | VIMPAT | lacosamide | TABLET;ORAL | 022253-004 | Oct 28, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lacosamide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 718577 | Start Trial |
| Japan | 3145414 | Start Trial |
| Austria | 202079 | Start Trial |
| Germany | 69705210 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for lacosamide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0888289 | SPC/GB09/007 | United Kingdom | Start Trial | 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 |
| 0888289 | CA 2009 00001 | Denmark | Start Trial | |
| 0888289 | C300376 | Netherlands | Start Trial | PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829 |
| 0888289 | 09C0006 | France | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.