Infant nevirapine — Competitive Intelligence Brief

Infant nevirapine (Infant nevirapine) 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

Infant nevirapine (Infant nevirapine) — Centers for Disease Control and Prevention. Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV reverse transcriptase to prevent viral replication in infants.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Infant nevirapine TARGET	Infant nevirapine	Centers for Disease Control and Prevention	phase 3	Non-nucleoside reverse transcriptase inhibitor (NNRTI)	HIV reverse transcriptase
Lamivudine Oral Solution	Lamivudine Oral Solution	ANRS, Emerging Infectious Diseases	marketed	Nucleoside reverse transcriptase inhibitor (NRTI)	HIV reverse transcriptase; Hepatitis B virus polymerase
tenofovir + emtricitabine + atazanavir-ritonavir	tenofovir + emtricitabine + atazanavir-ritonavir	Juan A. Arnaiz	marketed	Antiretroviral combination (NRTI + PI/r)	HIV reverse transcriptase, HIV protease
TRUVADA + Raltegravir	TRUVADA + Raltegravir	Fenway Community Health	marketed	Antiretroviral combination therapy (NRTI + INSTI)	HIV reverse transcriptase and HIV integrase
DOR/DTG/3TC	DOR/DTG/3TC	Insel Gruppe AG, University Hospital Bern	marketed	Antiretroviral combination (NNRTI + INSTI + NRTI)	HIV reverse transcriptase, HIV integrase
JULUCA	JULUCA	ViiV Healthcare	marketed	Antiretroviral combination (integrase inhibitor + NNRTI)	HIV integrase and HIV reverse transcriptase
First-line Antiretroviral Therapy	First-line Antiretroviral Therapy	UPECLIN HC FM Botucatu Unesp	marketed	Antiretroviral combination therapy (NRTI/NNRTI/PI/INSTI)	HIV reverse transcriptase, HIV protease, HIV integrase (depending on regimen components)

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