Multiple Product PrEP Program — Competitive Intelligence Brief

Multiple Product PrEP Program (Multiple Product PrEP Program) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antiretroviral combination therapy (nucleoside/nucleotide reverse transcriptase inhibitors). Area: Infectious Disease / Virology.

marketed Antiretroviral combination therapy (nucleoside/nucleotide reverse transcriptase inhibitors) HIV reverse transcriptase, HIV integrase Infectious Disease / Virology Small molecule

Target snapshot

Multiple Product PrEP Program (Multiple Product PrEP Program) — University of Alabama at Birmingham. A program providing multiple antiretroviral formulations for pre-exposure prophylaxis (PrEP) to prevent HIV acquisition in at-risk individuals.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Multiple Product PrEP Program TARGET	Multiple Product PrEP Program	University of Alabama at Birmingham	marketed	Antiretroviral combination therapy (nucleoside/nucleotide reverse transcriptase inhibitors)	HIV reverse transcriptase, HIV integrase
Tenofovir, lamivudine and efavirenz	Tenofovir, lamivudine and efavirenz	Centre for the AIDS Programme of Research in South Africa	marketed	Antiretroviral combination therapy (NRTI/NtRTI + NNRTI)	HIV reverse transcriptase, HIV integrase
Antiretroviral therapy	Antiretroviral therapy	ANRS, Emerging Infectious Diseases	marketed	Combination antiretroviral therapy (multiple classes: nucleoside/nucleotide reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors, entry inhibitors)	HIV reverse transcriptase, HIV integrase, HIV protease, HIV envelope glycoproteins (gp120/gp41), CCR5 co-receptor
Nevirapine, FTC, and Tenofovir	Nevirapine, FTC, and Tenofovir	University of Maryland, Baltimore	marketed	Antiretroviral combination (NNRTI + NRTI + NtRI)	HIV reverse transcriptase, HIV integrase
Atripla (r)	Atripla (r)	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	marketed	Antiretroviral combination (NNRTI + NRTI + NtRTI)	HIV reverse transcriptase, HIV integrase
Doravirine, Tenofovir, Lamivudine	Doravirine, Tenofovir, Lamivudine	Merck Sharp & Dohme LLC	marketed	Antiretroviral combination (NNRTI + NRTIs)	HIV reverse transcriptase, HIV integrase
Eviplera®	Eviplera®	St Stephens Aids Trust	marketed	Antiretroviral combination therapy (NNRTI + NRTI + NtRTI)	HIV reverse transcriptase, HIV integrase

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 therapy (nucleoside/nucleotide reverse transcriptase inhibitors) class)

1. University of Alabama at Birmingham · 1 drug in this class