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Details:
Through the license agreement, Amneal will commercialize ADL018 (omalizumab) in the US. It is being evaluated in late-stage clinical trial studies for the treatment of chronic idiopathic urticaria.
Lead Product(s): Omalizumab
Therapeutic Area: Immunology Product Name: ADL018
Highest Development Status: Phase IIIProduct Type: Large molecule
Recipient: Kashiv BioSciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 01, 2024
Details:
Narcan-Generic (naloxone HCl nasal spray) is an FDA approved, over-the-counter (OTC) medication which is indicated for the emergency treatment of opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Narcan-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 April 24, 2024
Details:
Pemrydi RTU, a folate analog metabolic inhibitor, is the first and only ready-to-use presentation of pemetrexed for injection and is approved in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC.
Lead Product(s): Pemetrexed,Pembrolizumab
Therapeutic Area: Oncology Product Name: Pemrydi RTU
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2024
Details:
Pemrydi (pemetrexed) is the first ready-to-use formulation approved for commercialization in the US market. It is indicated for patients suffering from non-small cell lung cancer.
Lead Product(s): Pemetrexed
Therapeutic Area: Oncology Product Name: Pemrydi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Shilpa Medicare
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2024
Details:
Ciprofloxacin and dexamethasone otic suspension is a combination product which is indicated for the treatment of Acute Otitis Externa in pediatric (age 6 months and older), adult & elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.
Lead Product(s): Ciprofloxacin,Dexamethasone
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Ciprodex-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 March 25, 2024
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.
Lead Product(s): Carbidopa,Etilevodopa
Therapeutic Area: Neurology Product Name: IPX203
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Zambon Group SpA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement February 27, 2024
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.
Lead Product(s): Carbidopa,Etilevodopa
Therapeutic Area: Neurology Product Name: IPX203
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2024
Details:
FML® suspension (fluorometholone) is a glucocorticoid receptor agnist. Its generic is approved by USFDA for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
Lead Product(s): Fluorometholone
Therapeutic Area: Ophthalmology Product Name: Fluorometholone-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 January 10, 2024
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
Recipient: Bial
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 07, 2023
Details:
Vascepa-Generic (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.
Lead Product(s): Icosapent Ethyl
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vascepa-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Strides Pharma Science
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 02, 2023