Reformulated Raltegravir — Competitive Intelligence Brief

Reformulated Raltegravir (Reformulated Raltegravir) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Integrase strand transfer inhibitor (INSTI). Area: Infectious Disease.

phase 3 Integrase strand transfer inhibitor (INSTI) HIV integrase Infectious Disease Small molecule

Target snapshot

Reformulated Raltegravir (Reformulated Raltegravir) — Merck Sharp & Dohme LLC. Reformulated raltegravir is an integrase strand transfer inhibitor that prevents HIV from integrating its genetic material into the host cell's DNA.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Reformulated Raltegravir TARGET	Reformulated Raltegravir	Merck Sharp & Dohme LLC	phase 3	Integrase strand transfer inhibitor (INSTI)	HIV integrase
Dolutegravir/Lamivudine as a single pill	Dolutegravir/Lamivudine as a single pill	Fundacion SEIMC-GESIDA	marketed	Antiretroviral combination (INSTI + NRTI)	HIV integrase; HIV reverse transcriptase
B/FTC/TAF	B/FTC/TAF	The University of Texas Health Science Center, Houston	marketed	Antiretroviral combination (integrase inhibitor + nucleoside/nucleotide reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
Biktarvy 50/200/25 Tab	Biktarvy 50/200/25 Tab	Radboud University Medical Center	marketed	Antiretroviral combination (integrase inhibitor + nucleotide/nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
cabotegravir, CAB	cabotegravir, CAB	ViiV Healthcare	marketed	Integrase strand transfer inhibitor (INSTI)	HIV integrase
Nevirapine, FTC, and Tenofovir	Nevirapine, FTC, and Tenofovir	University of Maryland, Baltimore	marketed	Antiretroviral combination (NNRTI + NRTI + NtRI)	HIV reverse transcriptase, HIV integrase
elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil	elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil	Fundacion Clinic per a la Recerca Biomédica	marketed	Antiretroviral combination (integrase inhibitor + pharmacokinetic booster + nucleoside/nucleotide reverse transcriptase inhibitors)	HIV integrase, CYP3A4, 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 (Integrase strand transfer inhibitor (INSTI) class)

1. ViiV Healthcare · 12 drugs in this class
2. National Institute of Allergy and Infectious Diseases (NIAID) · 5 drugs in this class
3. Merck Sharp & Dohme LLC · 5 drugs in this class
4. Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · 1 drug in this class
5. Germans Trias i Pujol Hospital · 1 drug in this class
6. Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux · 1 drug in this class
7. ANRS, Emerging Infectious Diseases · 1 drug in this class
8. Massachusetts General Hospital · 1 drug in this class
9. University of Colorado, Denver · 1 drug in this class
10. MU-JHU CARE · 1 drug in this class