Valganciclovir CMV Prophylaxis — Competitive Intelligence Brief

Valganciclovir CMV Prophylaxis (Valganciclovir CMV Prophylaxis) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nucleoside analog antiviral. Area: Infectious Disease / Virology.

phase 3 Nucleoside analog antiviral CMV DNA polymerase Infectious Disease / Virology Small molecule

Target snapshot

Valganciclovir CMV Prophylaxis (Valganciclovir CMV Prophylaxis) — University of California, San Francisco. Valganciclovir is a prodrug that is converted to ganciclovir, which inhibits cytomegalovirus (CMV) DNA polymerase to prevent viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Valganciclovir CMV Prophylaxis TARGET	Valganciclovir CMV Prophylaxis	University of California, San Francisco	phase 3	Nucleoside analog antiviral	CMV DNA polymerase
prophylactic Valganciclovir	prophylactic Valganciclovir	Rabin Medical Center	marketed	Nucleoside analog antiviral	CMV DNA polymerase
Prophylaxis with valganciclovir plus mycophenolate	Prophylaxis with valganciclovir plus mycophenolate	University of Bologna	phase 3	Combination antiviral and immunosuppressant	CMV DNA polymerase (valganciclovir); IMPDH type II (mycophenolate)
Placebo to VGCV	Placebo to VGCV	Merck Sharp & Dohme LLC	phase 3	Nucleoside analog antiviral	CMV DNA polymerase
Lonsurf	TIPIRACIL	Taiho Oncology Inc	marketed	Nucleoside Analog Antiviral [EPC]	Thymidine phosphorylase	2015-01-01
Dendrid	IDOXURIDINE	Novartis	marketed	Nucleoside Analog Antiviral	Thymidine kinase, cytosolic	1963-01-01
Peginterferon alfa-2a + ribavirin	Peginterferon alfa-2a + ribavirin	Hospital Clinico Universitario San Cecilio	marketed	Interferon alpha + nucleoside analog antiviral combination	Interferon-alpha receptor (IFNAR); HCV RNA-dependent RNA polymerase

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)

• 2029-09-22 — Lonsurf · RE46284 · US
• 2034-06-17 — Lonsurf · 10457666 · US
• 2034-06-17 — Lonsurf · 9527833 · US
• 2034-09-05 — Lonsurf · 9943537 · US
• 2037-02-03 — Lonsurf · 10456399 · US
• 2037-02-03 — Lonsurf · 10960004 · US

Sponsor landscape (Nucleoside analog antiviral class)

1. Merck Sharp & Dohme LLC · 3 drugs in this class
2. Hoffmann-La Roche · 2 drugs in this class
3. Göteborg University · 2 drugs in this class
4. Estetra · 1 drug in this class
5. Padagis LLC · 1 drug in this class
6. MinaPharm Pharmaceuticals · 1 drug in this class
7. French National Agency for Research on AIDS and Viral Hepatitis · 1 drug in this class
8. NYU Langone Health · 1 drug in this class
9. Assistance Publique - Hôpitaux de Paris · 1 drug in this class
10. Ain Shams University · 1 drug in this class