Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate — Competitive Intelligence Brief

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antiretroviral combination (NNRTI + NRTIs). Area: Infectious Disease / Virology.

phase 3 Antiretroviral combination (NNRTI + NRTIs) HIV reverse transcriptase Infectious Disease / Virology Small molecule

Target snapshot

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate) — Merck Sharp & Dohme LLC. This combination drug inhibits HIV reverse transcriptase and integrase to block viral replication and reduce HIV viral load.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate TARGET	Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate	Merck Sharp & Dohme LLC	phase 3	Antiretroviral combination (NNRTI + NRTIs)	HIV reverse transcriptase
Darunavir / Ritonavir + Tenofovir / Emtricitabine	Darunavir / Ritonavir + Tenofovir / Emtricitabine	Juan A. Arnaiz	marketed	Antiretroviral combination (protease inhibitor + nucleoside reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase
Highly active antiretroviral therapy	Highly active antiretroviral therapy	PETHEMA Foundation	marketed	Antiretroviral combination therapy	HIV reverse transcriptase, HIV protease, HIV integrase (depending on regimen composition)
Immediate switch to TDF/FTC/RPV	Immediate switch to TDF/FTC/RPV	Azienda Ospedaliera San Gerardo di Monza	marketed	Antiretroviral combination therapy (NRTI/NNRTI)	HIV reverse transcriptase, HIV integrase
Dolutegravir/Lamivudine as a single pill	Dolutegravir/Lamivudine as a single pill	Fundacion SEIMC-GESIDA	marketed	Antiretroviral combination (INSTI + NRTI)	HIV integrase; HIV reverse transcriptase
elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil	elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil	Fundacion Clinic per a la Recerca Biomédica	marketed	Antiretroviral combination (integrase inhibitor + pharmacokinetic booster + nucleoside/nucleotide reverse transcriptase inhibitors)	HIV integrase, CYP3A4, HIV reverse transcriptase
All licensed antiretroviral medications	All licensed antiretroviral medications	University of Minnesota	marketed	Antiretroviral agents (multiple classes: NRTIs, NNRTIs, PIs, INSTIs, entry inhibitors)	Multiple (HIV reverse transcriptase, HIV protease, HIV integrase, CCR5, CXCR4, gp120/gp41)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Antiretroviral combination (NNRTI + NRTIs) class)

1. Merck Sharp & Dohme LLC · 2 drugs in this class
2. Instituto Mexicano del Seguro Social · 1 drug in this class