Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lupin Gains Tentative USFDA Approval for Amifampridine Tablets
Details : Firdapse-Generic (amifampridine) is an oral, nonspecific, voltage-dependent, potassium channel blocker that is indicated to treat Lambert-Eaton myasthenic syndrome.
Product Name : Firdapse-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 17, 2025
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Catalyst Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Catalyst Pharmaceuticals Announces Sub-Licensee DyDo Pharma Launched FIRDAPSE® in Japan
Details : Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium channel blocker that is indicated to treat Lambert-Eaton myasthenic syndrome.
Product Name : Firdapse
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 21, 2025
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Catalyst Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Catalyst Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Catalyst Pharma Sub-Licensee Gets Approval For FIRDAPSE® in Japan
Details : Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium channel blocker that received approval to treat Lambert-Eaton myasthenic syndrome in Japan.
Product Name : Firdapse
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 24, 2024
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Catalyst Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Catalyst Receives U.S. FDA Approval For Increased Maximum Daily Dose For FIRDAPSE®
Details : Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium channel blocker that recieved FDA approval for its max dose to treat Lambert-Eaton myasthenic syndrome.
Product Name : Firdapse
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 30, 2024
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Dydo Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization.
Product Name : Firdapse
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 18, 2023
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Dydo Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Firdapse (amifampridine) is approved for the treatment of Lambert-Eaton myasthenic syndrome and FDA recently accepted to review the Company's sNDA to increase the indicated maximum daily dosage of amifampridine tablets 10 mg from 80mg to 100mg.
Product Name : Firdapse
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 13, 2023
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Firdapse (amifampridine) is a broad spectrum potassium channel blocker. sNDA submission has been planned to increase indicated maximum dose for firdapse® from 80 mg per day to 100 mg per day for the treatment of lambert eaton myasthenic syndrome ("LEMS"...
Product Name : Firdapse
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 05, 2023
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Firdapse (amifampridine phosphate) is a broad spectrum potassium channel blocker. Amifampridine is the only evidence-based, FDA-approved treatment for adult patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
Product Name : Firdapse
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 23, 2023
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : KYE Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : A favorable decision from the Federal Court of Canada setting aside second time decision of Canada’s national healthcare regulatory agency, Health Canada, to approve Ruzurgi® (amifampridine) for Lambert-Eaton Myasthenic Syndrome ("LEMS") patients.
Product Name : Firdapse
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 03, 2022
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : KYE Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Supplemental New Drug Application ("sNDA") to expand the indicated age range for FIRDAPSE® (amifampridine) Tablets 10 mg to include pediatric patients, six years of age and older for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS").
Product Name : Firdapse
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 29, 2022
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable