TMC125, Darunavir; Ritonavir — Competitive Intelligence Brief

TMC125, Darunavir; Ritonavir (TMC125, Darunavir; Ritonavir) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: HIV protease inhibitor. Area: Infectious Diseases.

phase 3 HIV protease inhibitor HIV protease Infectious Diseases Small molecule

Target snapshot

TMC125, Darunavir; Ritonavir (TMC125, Darunavir; Ritonavir) — Tibotec, Inc. TMC125, Darunavir; Ritonavir is a combination of HIV protease inhibitors that work by blocking the protease enzyme, preventing the maturation of viral particles.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
TMC125, Darunavir; Ritonavir TARGET	TMC125, Darunavir; Ritonavir	Tibotec, Inc	phase 3	HIV protease inhibitor	HIV protease
Reyataz + Epzicom	Reyataz + Epzicom	ViiV Healthcare	marketed	Antiretroviral combination (protease inhibitor + nucleoside reverse transcriptase inhibitors)	HIV protease; HIV reverse transcriptase
Lopinavir/ritonavir (Kaletra)	Lopinavir/ritonavir (Kaletra)	Abbott	marketed	HIV protease inhibitor	HIV protease
Lopinavir/r plus saquinavir	Lopinavir/r plus saquinavir	The HIV Netherlands Australia Thailand Research Collaboration	marketed	HIV protease inhibitor combination	HIV protease
Darunavir/Ritonavir (Prezista)	Darunavir/Ritonavir (Prezista)	Kowa Research Institute, Inc.	marketed	HIV protease inhibitor	HIV protease
Darunavir/Cobicistat (FDC)	Darunavir/Cobicistat (FDC)	Janssen Scientific Affairs, LLC	marketed	HIV protease inhibitor with pharmacokinetic booster	HIV protease; CYP3A4
Reyataz + Norvir + Truvada	Reyataz + Norvir + Truvada	ViiV Healthcare	marketed	Antiretroviral combination therapy (protease 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 (HIV protease inhibitor class)

1. Bristol-Myers Squibb · 5 drugs in this class
2. ViiV Healthcare · 3 drugs in this class
3. GlaxoSmithKline · 2 drugs in this class
4. Drugs for Neglected Diseases · 2 drugs in this class
5. Germans Trias i Pujol Hospital · 2 drugs in this class
6. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · 1 drug in this class
7. DualityBio Inc. · 1 drug in this class
8. French National Agency for Research on AIDS and Viral Hepatitis · 1 drug in this class
9. Far East Bio-Tec Co., Ltd · 1 drug in this class
10. Community Research Initiative of New England · 1 drug in this class