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Details:
Strides Pharma, has received approval for Ursodiol Capsules USP, 300 mg from the USFDA. The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Actigall® Capsules, 300 mg, of Allergan Sales, LLC.
Lead Product(s): Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
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 25, 2021
Details:
USFDA approved generic version of Ursodiol Tablet, which is indicated for the treatment of patients with Primary Biliary Cirrhosis. It inhibits the absorption of cholesterol in the intestine and the secretion of cholesterol into bile, decreasing biliary cholesterol saturation.
Lead Product(s): Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Urso Forte-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 August 21, 2020
Details:
Through the acquisition, Alfasigma adds Ocaliva (obeticholic acid), a farnesoid X receptor agonist approved in the United States for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA.
Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alfasigma
Deal Size: $794.0 million Upfront Cash: $794.0 million
Deal Type: Acquisition September 26, 2023
Details:
Agreement includes rights for Advanz to commercialize orphan drug Ocaliva® (Obeticholic Acid) for PBC outside the U.S., as well as the transition to Advanz of the international commercial and medical infrastructure of Intercept.
Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Advanz Pharma
Deal Size: $450.0 million Upfront Cash: $405.0 million
Deal Type: Acquisition May 05, 2022
Details:
A recent study evaluating Ocaliva® (obeticholic acid) in patients diagnosed with primary biliary cholangitis (PBC) revealed similar patient-reported adverse effects as in clinical trials while also exploring patient out-of-pocket cost and utilization.
Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Duquesne University School of Pharmacy
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2022
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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
