API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
0
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
Details:
Motpoly (lacosamide) is an antiepileptic drug that works by blocking sodium channel alpha subunit. It is being evaluated for the treatment of partial-onset seizures in adults and in pediatric patients.
Lead Product(s): Lacosamide
Therapeutic Area: Neurology Product Name: Motpoly
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2024
Details:
Lacosamide is a functionalized amino acid that has activity in the maximal electroshock seizure test, and is indicated for the adjunctive treatment of partial-onset seizures and diabetic neuropathic pain.
Lead Product(s): Lacosamide
Therapeutic Area: Neurology Product Name: Lacosamide-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Details:
Lacosamide selectively enhances slow inactivation of voltage-gated sodium channels and possibly interacts with collapsin response mediator protein-2. It is indicated for treating partial onset seizures.
Lead Product(s): Lacosamide
Therapeutic Area: Neurology Product Name: Vimpat-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 09, 2023
Details:
Fresenius Kabi Lacosamide Injection, USP is an approved treatment option for partial-onset seizures in patients 17 years of age and older and is available in 200 mg per 20 mL single-dose vials.
Lead Product(s): Lacosamide
Therapeutic Area: Neurology Product Name: Lacosamide-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2022
Details:
Lacosamide Tablets, USP (generic version of Vimpat), indicated for the prevention and control of seizures, enhances the slow inactivation of voltage-gated sodium channels without affecting the fast inactivation of voltage-gated sodium channels.
Lead Product(s): Lacosamide
Therapeutic Area: Neurology Product Name: Lacosamide-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Breckenridge Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
Details:
The approval granted by U.S.FDA for ANDA of Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg and 200 mg, a generic version of Vimpat®2 Tablets, 50 mg, 100 mg, 150 mg and 200 mg will be used for prevention and control of seizures.
Lead Product(s): Lacosamide
Therapeutic Area: Neurology Product Name: Lacosamide-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
Details:
The PGTCS approval is based, in part, on results of a Phase 3 study. All three VIMPAT formulations, intravenous injections, are now indicated for the treatment of partial-onset seizures and as adjunctive therapy in the treatment of PGTCS in patients aged 4 and above.
Lead Product(s): Lacosamide
Therapeutic Area: Neurology Product Name: Vimpat
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
The positive opinion is based, in part, on results from a phase 3 study of lacosamide as adjunctive treatment for uncontrolled primary generalized tonic-clonic seizures (PGTCS), recently published in the Journal of Neurology, Neurosurgery & Psychiatry.
Lead Product(s): Lacosamide
Therapeutic Area: Neurology Product Name: Vimpat
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
Study met primary and secondary endpoints of significantly lowering the risk of developing a second primary generalized tonic-clonic seizure during a 24-week treatment and a significantly higher rate of freedom from PGTCS during the treatment period compared with placebo.
Lead Product(s): Lacosamide
Therapeutic Area: Neurology Product Name: Vimpat
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2020