Dapivirine Vaginal Ring-004 — Competitive Intelligence Brief

Dapivirine Vaginal Ring-004 (Dapivirine Vaginal Ring-004) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Non-nucleoside reverse transcriptase inhibitor (NNRTI). Area: Infectious Disease / Virology.

phase 3 Non-nucleoside reverse transcriptase inhibitor (NNRTI) HIV reverse transcriptase Infectious Disease / Virology Small molecule

Target snapshot

Dapivirine Vaginal Ring-004 (Dapivirine Vaginal Ring-004) — International Partnership for Microbicides, Inc.. Dapivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV replication when released from a vaginal ring formulation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Dapivirine Vaginal Ring-004 TARGET	Dapivirine Vaginal Ring-004	International Partnership for Microbicides, Inc.	phase 3	Non-nucleoside reverse transcriptase inhibitor (NNRTI)	HIV reverse transcriptase
EFV	EFV	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	marketed	Non-nucleoside reverse transcriptase inhibitor (NNRTI)	HIV reverse transcriptase
Twice-daily ABC+3TC	Twice-daily ABC+3TC	Medical Research Council	marketed	Nucleoside reverse transcriptase inhibitor (NRTI) combination	HIV reverse transcriptase
Tenofovir (TDF)	Tenofovir (TDF)	French National Agency for Research on AIDS and Viral Hepatitis	marketed	Nucleotide reverse transcriptase inhibitor (NtRTI)	HIV reverse transcriptase; Hepatitis B polymerase
AZT+3TC+ABV (Trizivir)	AZT+3TC+ABV (Trizivir)	Fundacion SEIMC-GESIDA	marketed	Nucleoside reverse transcriptase inhibitor (NRTI) combination	HIV reverse transcriptase
Regimen:TDF+3TC+EFV	Regimen:TDF+3TC+EFV	National Center for AIDS/STD Control and Prevention, China CDC	marketed	Antiretroviral combination therapy (NRTI + NNRTI)	HIV reverse transcriptase
lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine	lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine	University of British Columbia	marketed	Antiretroviral combination therapy (protease inhibitor + non-nucleoside reverse transcriptase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase

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 (Non-nucleoside reverse transcriptase inhibitor (NNRTI) class)

1. ViiV Healthcare · 4 drugs in this class
2. National Institute of Allergy and Infectious Diseases (NIAID) · 3 drugs in this class
3. Merck Sharp & Dohme LLC · 2 drugs in this class
4. French National Agency for Research on AIDS and Viral Hepatitis · 1 drug in this class
5. Germans Trias i Pujol Hospital · 1 drug in this class
6. International Partnership for Microbicides, Inc. · 1 drug in this class
7. Janssen Infectious Diseases BVBA · 1 drug in this class
8. Janssen-Cilag S.p.A. · 1 drug in this class
9. Johns Hopkins Bloomberg School of Public Health · 1 drug in this class
10. Tibotec Pharmaceuticals, Ireland · 1 drug in this class