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Details:
USFDA approved a combination drug Dolutegravir, Lamivudine and Tenofovir Disproxil Fumurate a complete regimen for treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs.
Lead Product(s): Dolutegravir Sodium,Lamivudine,Tenofovir Disproxil Fumurate
Therapeutic Area: Infections and Infectious Diseases 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 15, 2023
Details:
USFDA approved a generic verion of Dolutegravir for the treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs. It inhibits HIV-integrase which is necessary for viral cell replication.
Lead Product(s): Dolutegravir Sodium
Therapeutic Area: Infections and Infectious Diseases Product Name: Tivicay-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 14, 2023
Details:
Dolutegravir is a HIV type 1 integrase inhibitor, which is being evaluated in combination with daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide regimen for the treatment of HIV-associated tuberculosis.
Lead Product(s): Dolutegravir Sodium,Rifapentine,Moxifloxacin
Therapeutic Area: Infections and Infectious Diseases Product Name: Tivicay
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: ViiV Healthcare
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2024
Details:
Dolutegravir tablets is a HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Lead Product(s): Dolutegravir Sodium
Therapeutic Area: Infections and Infectious Diseases Product Name: Tivicay-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: AIDS Healthcare Foundation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2023
Details:
The fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension is indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 6 kg.
Lead Product(s): Abacavir,Dolutegravir Sodium,Lamivudine
Therapeutic Area: Infections and Infectious Diseases 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 05, 2023
Details:
Dolutegravir tablets is a HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Lead Product(s): Dolutegravir Sodium
Therapeutic Area: Infections and Infectious Diseases Product Name: Tivicay-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 04, 2023
Details:
The combination inhibits HIV-1 replication, in which dolutegravir inhibits HIV integrase and blocks the strand transfer step of retroviral DNA integration where emtricitabine and tenofovir alafenamide inhibits the activity of the HIV-1 reverse transcriptase.
Lead Product(s): Dolutegravir Sodium,Emtricitabine,Tenofovir Alafenamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Dolutegravir/Emtricitabine/Tenofovir Alafenamide-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 31, 2023
Details:
Dolutegravir Sodium, where dolutegravir is an integrase inhibitor while rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which is used as an oral combination for the treatment of HIV-1 infections in treatment-naive patients.
Lead Product(s): Dolutegravir Sodium,Rilpivirine Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Product Name: Dolutegravir/Rilpivirine-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 16, 2023
Details:
Dovato (dolutegravir sodium), is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen.
Lead Product(s): Dolutegravir Sodium,Lamivudine
Therapeutic Area: Infections and Infectious Diseases Product Name: Dovato
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 25, 2022
Details:
In addition, a supplemental new drug application (sNDA) has been approved for Triumeq tablet, lowering the minimum weight that a child with human immunodeficiency virus type 1 (HIV-1) can be prescribed this medicine to 25kgs from 40kgs.
Lead Product(s): Dolutegravir Sodium,Lamivudine,Abacavir
Therapeutic Area: Infections and Infectious Diseases Product Name: Triumeq
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 30, 2022
Details:
ViiV Healthcare enables generic versions of dolutegravir to be manufactured and sold royalty-free for the treatment of children living with HIV in all least-developed, low-income, lower-middle-income and sub-Saharan Africa countries, also some upper-middle-income countries.
Lead Product(s): Abacavir,Dolutegravir Sodium,Lamivudine
Therapeutic Area: Infections and Infectious Diseases Product Name: Triumeq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2022
Details:
Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed, on a stable ARV regimen with no history of treatment failure.
Lead Product(s): Dolutegravir Sodium,Lamivudine
Therapeutic Area: Infections and Infectious Diseases Product Name: Dovato
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 07, 2022
Details:
New dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine to extend its current approval for Triumeq for younger children living with HIV.
Lead Product(s): Dolutegravir Sodium,Lamivudine,Abacavir
Therapeutic Area: Infections and Infectious Diseases Product Name: Triumeq
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 October 04, 2021
Details:
Dovato is a once-daily, single-pill, 2-drug regimen (2DR) that combines the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay, 50 mg) with the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, 300 mg).
Lead Product(s): Dolutegravir Sodium,Lamivudine
Therapeutic Area: Infections and Infectious Diseases Product Name: Dovato
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 29, 2021
Details:
144-week findings from TANGO study evaluate switching to the fixed-dose combination of Dovato (dolutegravir/lamivudine) compared to continuation of tenofovir alafenamide (TAF)-based regimens of at least three drugs in virologically suppressed people living with HIV.
Lead Product(s): Dolutegravir Sodium,Lamivudine
Therapeutic Area: Infections and Infectious Diseases Product Name: Dovato
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 22, 2021
Details:
The 2-drug regimen Dovato (dolutegravir/lamivudine) demonstrated non-inferior efficacy compared to continuation of a current antiretroviral regimen of at least three drugs, with zero cases of virologic failure and no development of resistance, in adults with HIV-1.
Lead Product(s): Dolutegravir Sodium,Lamivudine
Therapeutic Area: Infections and Infectious Diseases Product Name: Dovato
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 17, 2021
Details:
Lupin has received tentative approval from the United States FDA under the U.S. President’s Emergency Plan for AIDS Relief for its NDA for Dolutegravir, Lamivudine & Tenofovir Disoproxil Fumarate Tablets, 50 mg/300 mg/300 mg, and antiretroviral Fixed Dose Combination.
Lead Product(s): Dolutegravir Sodium,Lamivudine,Tenofovir Disoproxil Fumarate
Therapeutic Area: Infections and Infectious Diseases 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 June 30, 2021
Details:
The authorisation includes updated dosing recommendations, for Tivicay (dolutegravir) film-coated tablets (10mg, 25mg and 50mg) for children 6 years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands.
Lead Product(s): Dolutegravir Sodium
Therapeutic Area: Infections and Infectious Diseases Product Name: Tivicay
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 13, 2021
Details:
Innovative partnership has accelerated development of first generic pediatric dispersible formulation of dolutegravir (DTG), the recommended first-line HIV treatment.
Lead Product(s): Dolutegravir Sodium
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Clinton Health Access Initiative
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 01, 2020
Details:
Pediatric dolutegravir tablets were approved for use in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in pediatric patients at least 4 weeks old and weighing at least 3 kg.
Lead Product(s): Dolutegravir Sodium
Therapeutic Area: Infections and Infectious Diseases 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 November 23, 2020
Details:
Dovato allows adults living with HIV to reduce the number of antiretroviral therapies they take each day, while maintaining efficacy and high barrier to resistance comparable to tenofovir-based regimens of at least three drugs.
Lead Product(s): Dolutegravir Sodium,Lamivudine
Therapeutic Area: Infections and Infectious Diseases Product Name: Dovato
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
U.S FDA has approved Tivicay PD (dolutegravir) tablets for oral suspension, which are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in paediatric patients.
Lead Product(s): Dolutegravir Sodium
Therapeutic Area: Infections and Infectious Diseases 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 June 15, 2020
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