Details:
The launch of Sapropterin Dihydrochloride Powder for Oral Solution, 100mg, a therapeutic equivalent generic version of Kuvan® (sapropterin dihydrochloride) Powder for Oral Solution, 100 mg, USP, is approved by the U.S. Food and Drug Administration (USFDA).
Lead Product(s): Sapropterin Hydrochloride
Therapeutic Area: Genetic Disease Product Name: Sapropterin Dihydrochloride-Generic
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2021
Details:
The launch of generic version of Sapropterin Dihydrochloride Tablets, for Oral Use, illustrating the commitment to bring affordable generic medicines to market for patients. Dr. Reddy’s Sapropterin Dihydrochloride Tablets, 100 mg are available in bottle count sizes of 120.
Lead Product(s): Sapropterin Hydrochloride
Therapeutic Area: Genetic Disease Product Name: Sapropterin Dihydrochloride-Generic
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 03, 2020
Details:
Penicillamine-Generic is a chelating agent used in the treatment of Wilson’s disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy.
Lead Product(s): Penicillamine
Therapeutic Area: Genetic Disease Product Name: Penicillamine-Generic
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 27, 2020
Details:
Icatibant injection, for subcutaneous is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema in adults 18 years of ageand older.
Lead Product(s): Icatibant Acetate
Therapeutic Area: Genetic Disease Product Name: Firazyr-Generic
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 16, 2023
Details:
Colchicine tablets inhibits the beta tubulin polymerisation, which is indicated for prophylaxis of gout flares in adults and Familial Mediterranean fever (FMF) in adults and children 4 years or older
Lead Product(s): Colchicine
Therapeutic Area: Genetic Disease Product Name: Colcrys-Generic
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 12, 2022
Details:
This marks Glenmark's first synthetic decapeptide Icatibant Injection approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina.
Lead Product(s): Icatibant Acetate
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2021
Details:
Penicillamine tablets USP, 250 mg, are the generic equivalent of Depen tablets, 250 mg, of Mylan and indicated in the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to conventional therapy.
Lead Product(s): Penicillamine
Therapeutic Area: Genetic Disease Product Name: Depen
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2021
Details:
Lupin has received approval for its Penicillamine Tablets USP, 250 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Depen® Tablets, 250 mg, of Mylan Specialty, L.P.
Lead Product(s): Penicillamine
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2020
Details:
Under the agreements, Exeltis Healthcare will commercialize NaMuscla® in Spain and Portugal, Cresco Pharma B.V will commercialize NaMuscla® in the Netherlands and Macure Pharma ApS in the Nordic countries. Lupin will continue commercialization of NaMuscla® in Germany and UK.
Lead Product(s): Mexiletine
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Exeltis Healthcare
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 03, 2020