Lead Product(s) : Dihydroergotamine Mesylate
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amneal Wins FDA Nod for Brekiya for Migraine & Cluster Headache Relief
Details : Brekiya (dihydroergotamine mesylate) is the first and only dihydroergotamine (DHE) autoinjector for acute treatment of migraine with/without aura & acute treatment of cluster headaches in adults.
Product Name : Brekiya
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 15, 2025
Lead Product(s) : Dihydroergotamine Mesylate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amneal Phase 3 Data Show CREXONT Improved Sleep in Parkinson’s Disease
Details : Crexont is a combination of carbidopa and levodopa indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism.
Product Name : Crexont
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 07, 2025
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Memantine Hydrochloride,Donepezil
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amneal Receives FDA Approval for Memantine/Donepezil and Tentative Approval for Rifaximin
Details : A generic combination of memantine HCl extended-release, a NMDA receptor antagonist, and donepezil HCl, an acetylcholinesterase inhibitor, is approved for dementia of the Alzheimer’s.
Product Name : Namzaric
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 23, 2025
Lead Product(s) : Memantine Hydrochloride,Donepezil
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amneal Launches CREXONT® Extended-Release Capsules For Parkinson’s Disease
Details : Crexont is a novel, oral carbidopa/levodopa (CD/LD) formulation that combines immediate-release granules and extended-release pellets. It indicated for the treatment of Parkinson’s disease
Product Name : IPX203
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 23, 2024
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Propofol
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amneal Receives U.S. FDA Approval For Propofol Injectable Emulsion Single Dose Vials
Details : Diprivan-Generic (propofol) is approved in the US, which is an intravenous drug commonly used in hospitals for the induction and maintenance of anesthesia and sedation.
Product Name : Diprivan-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 20, 2024
Lead Product(s) : Propofol
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amneal Announces Complete Response Resubmission for IPX203 New Drug Application
Details : IPX203 (carbidopa/levodopa) is a novel, oral extended-release capsule formulation. It is being evaluated in phase 3 clinical trials for the treatment of parkinson's disease with motor fluctuations.
Product Name : IPX203
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 02, 2024
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amneal Receives FDA Approval for IPX203 for Parkinson’s Disease as CREXONT® Capsules
Details : Crexont (carbidopa/levodopa) is a novel, oral extended-release capsule formulation. It is indicated for the treatment of parkinson's disease with motor fluctuations.
Product Name : IPX203
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 08, 2024
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Zambon Group SpA
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Amneal Enters into Exclusive European Licensing Agreement with Zambon Biotech for IPX203
Details : Through the licensing agreement, Zambon will commercialize IPX203, an oral formulation of carbidopa/levodopa extended-release capsules designed for the treatment of Parkinson’s disease.
Product Name : IPX203
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
February 27, 2024
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Zambon Group SpA
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amneal Receives U.S. FDA Complete Response Letter for IPX203
Details : IPX203 is a novel, oral formulation of contains immediate-release granules and extended-release capsules designed for the treatment of Parkinson’s disease.
Product Name : IPX203
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 07, 2023
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : IPX203 (levodopa) is a novel, oral formulation of CD/LD extended-release capsules designed for the treatment of Parkinson’s disease. IPX203 contains immediate-release granules and extended-release beads.
Product Name : IPX203
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 11, 2022
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable