X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
Europe
0
Canada
0
Australia
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
0
Details:
Under the agreement, Amneal will have exclusive rights to market and distribute ONGENTYS (opicapone), a highly-selective COMT inhibitor, which is approved by USFDA as an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experiencing Off episodes.
Lead Product(s): Opicapone
Therapeutic Area: Neurology Product Name: Ongentys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Amneal Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 07, 2023
Details:
ONGENTYS (Opicapone) is a once-daily, oral, peripheral, selective, and reversible catechol-O-methyltransferase (COMT) inhibitor as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "OFF"episodes.
Lead Product(s): Opicapone
Therapeutic Area: Neurology Product Name: Ongentys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Details:
ONGENTYS (opicapone) is a reversible COMT inhibitor approved by the U.S. FDA as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease. ONGENTYS inhibits the COMT enzyme, which breaks down levodopa, making more levodopa available to reach the brain.
Lead Product(s): Opicapone
Therapeutic Area: Neurology Product Name: Ongentys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2022
Details:
Results of the post-hoc analysis for ONGENTYS® (opicapone) Capsules indicate that 34.4% (332/964) of participants experienced an OFF episode before going to sleep for a mean duration of 1.8±1.2 hours.
Lead Product(s): Opicapone
Therapeutic Area: Neurology Product Name: Ongentys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2022
Details:
The new agreement provides both companies with a long-term partnership that will ensure continued supply for patients across the globe. Opicapone (Ongentys) is approved in Europe, USA, South Korea, Taiwan, Australia and Japan.
Lead Product(s): Opicapone
Therapeutic Area: Neurology Product Name: Ongentys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bial
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 01, 2020
Details:
Data demonstrated that newly approved Ongentys significantly reduced "off" time as an add-on therapy in patients with Parkinson's Disease taking Levodopa/Carbidopa only in a pooled Post-Hoc, sub-group analysis of Phase III studies.
Lead Product(s): Opicapone
Therapeutic Area: Neurology Product Name: Ongentys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
