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Amneal Pharmaceuticals
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U.S.A
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400 Crossing Boulevard, 3rd Floor Bridgewater, New Jersey 08807
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+1 908 947 3120
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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

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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

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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

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Under the agreement, Amneal in-licensed Icosapent ethyl acid soft gel capsules, a product referencing Vascepa and an ethyl ester of eicosapentaenoic acid that is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.


Lead Product(s): Icosapent Ethyl

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vascepa-Generic

Highest Development Status: ApprovedProduct Type: Small molecule

Recipient: Amneal Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement December 01, 2023

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Under the terms of agreement, mAbxience will fully develop the biosimilar, Denosumab (ref Prolia and XGEVA) and manufacture in it's GMP-approved facilities, while Amneal will guide the product through regulatory approval and have exclusive commercialization rights in the US.


Lead Product(s): Denosumab

Therapeutic Area: Musculoskeletal Product Name: MB-09

Highest Development Status: Phase IIIProduct Type: Large molecule

Recipient: Mabxience

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition October 12, 2023

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Calcium gluconate in sodium chloride injection is a small volume parenteral bag indicated for the treatment of acute symptomatic hypocalcemia in pediatric and adult patients.


Lead Product(s): Calcium Gluconate

Therapeutic Area: Nutrition and Weight Loss 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 September 06, 2023

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Sevelamer carbonate film coated tablet is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.


Lead Product(s): Sevelamer Hydrochloride

Therapeutic Area: Nephrology Product Name: Renvela-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 September 06, 2023

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Lisdexamfetamine dimesylate capsules, for oral use is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder and Moderate to Severe Binge Eating Disorder (BED) in adults.


Lead Product(s): Lisdexamfetamine Dimesylate

Therapeutic Area: Psychiatry/Psychology Product Name: Vyvanse-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 September 06, 2023

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Albuterol sulfate inhalation powder is first and only breath-actuated, digital SABA inhaler, which is used for prevention of bronchospasm related to exercise-induced or reversible obstructive airway disease.


Lead Product(s): Salbutamol Sulphate

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Proair HFA-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 July 26, 2023

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sodium oxybate oral solution indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy.


Lead Product(s): Sodium Oxybate

Therapeutic Area: Sleep Product Name: Xyrem-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 July 03, 2023

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