Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Darunavir,Cobicistat
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
J&J seeks expanded approvals for paediatric HIV-1 therapy
Details : Filed a sNDA with the USFDA seeking expanded approval for the use of its HIV-1 therapy, PREZCOBIX (darunavir/cobicistat), in children aged six years and above, weighing at least 25kg.
Brand Name : Prezcobix
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 05, 2024
Lead Product(s) : Darunavir,Cobicistat
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Darunavir
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Zydus gets USFDA Nod for Antiviral Drug used in HIV Treatment
Details : Prezista (darunavir) is a protease inhibitor antiviral medicine which is approved by USFDA for the treatment of Human Immunodeficiency Virus (HIV-1) Infection.
Brand Name : Prezista
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 15, 2023
Lead Product(s) : Darunavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Darunavir
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Aurobindo Pharma Gets USFDA Nod for HIV drug
Details : Darunavir tablets, generic of Prezista, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older.
Brand Name : Prezista-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 29, 2023
Lead Product(s) : Darunavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Darunavir
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lupin Receives Approval from U.S. FDA for Darunavir Tablets
Details : Darunavir Tablets, 600 mg and 800 mg, a generic equivalent of Prezista® Tablets of Janssen Products, to treat human immunodeficiency virus (HIV) infection in adults and children 3 years of age and older.
Brand Name : Darunavir- Generic
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 04, 2022
Lead Product(s) : Darunavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Darunavir,Cobicistat,Emtricitabine
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Undisclosed
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Johnson & Johnson says no evidence HIV drug works against coronavirus
Details : Janssen has no clinical nor pharmacological evidence to support the inclusion of DRV/cobicistat in treatment guidelines for COVID-19.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 16, 2020
Lead Product(s) : Darunavir,Cobicistat,Emtricitabine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Undisclosed
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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