Over-encapsulated efavirenz — Competitive Intelligence Brief

Over-encapsulated efavirenz (Over-encapsulated efavirenz) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Non-nucleoside reverse transcriptase inhibitor (NNRTI). Area: Infectious Disease.

marketed Non-nucleoside reverse transcriptase inhibitor (NNRTI) HIV reverse transcriptase Infectious Disease Small molecule

Target snapshot

Over-encapsulated efavirenz (Over-encapsulated efavirenz) — University of Minnesota. Over-encapsulated efavirenz is a reformulation of the HIV reverse transcriptase inhibitor efavirenz designed to improve tolerability by reducing peak plasma concentrations and CNS exposure through modified-release encapsulation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Over-encapsulated efavirenz TARGET	Over-encapsulated efavirenz	University of Minnesota	marketed	Non-nucleoside reverse transcriptase inhibitor (NNRTI)	HIV reverse transcriptase
atazanavir/tenofovir/emtricitabine	atazanavir/tenofovir/emtricitabine	Community Research Initiative of New England	marketed	Antiretroviral combination (protease inhibitor + nucleoside/nucleotide reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase
didanosine + lamivudine + efavirenz	didanosine + lamivudine + efavirenz	Clinical Trial Agency of HIV Study Group	marketed	Antiretroviral combination therapy (NRTI + 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
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
Didanosine (enteric-coated)	Didanosine (enteric-coated)	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	marketed	Nucleoside reverse transcriptase inhibitor (NRTI)	HIV reverse transcriptase
DTG/3TC/ABC + ELV/COBI/FTC/TAF	DTG/3TC/ABC + ELV/COBI/FTC/TAF	Fundacion SEIMC-GESIDA	marketed	Antiretroviral combination therapy (integrase inhibitor + nucleoside/nucleotide reverse transcriptase inhibitors)	HIV integrase, 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