valganciclovir [Valcyte] — Competitive Intelligence Brief

valganciclovir [Valcyte] (valganciclovir [Valcyte]) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nucleoside analog antiviral. Area: Infectious Disease / Virology.

marketed Nucleoside analog antiviral Cytomegalovirus (CMV) DNA polymerase Infectious Disease / Virology Small molecule

Target snapshot

valganciclovir [Valcyte] (valganciclovir [Valcyte]) — Hoffmann-La Roche. Valganciclovir is a prodrug that is converted to ganciclovir, which inhibits viral DNA polymerase and prevents replication of cytomegalovirus (CMV).

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
valganciclovir [Valcyte] TARGET	valganciclovir [Valcyte]	Hoffmann-La Roche	marketed	Nucleoside analog antiviral	Cytomegalovirus (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
Acyclovir (ACV)	Acyclovir (ACV)	French National Agency for Research on AIDS and Viral Hepatitis	marketed	Nucleoside analog antiviral	Viral DNA polymerase (herpes simplex virus and varicella-zoster virus)
Ribavirin (R)	Ribavirin (R)	Tibotec Pharmaceuticals, Ireland	marketed	Nucleoside analog antiviral	Viral RNA-dependent RNA polymerase; guanosine triphosphate metabolism
Ribavirin in Arm 1	Ribavirin in Arm 1	MinaPharm Pharmaceuticals	marketed	Nucleoside analog antiviral	Viral RNA polymerase; IMPDH (inosine monophosphate dehydrogenase)
standard treatment COVID-19 + Triazavirin	standard treatment COVID-19 + Triazavirin	Ain Shams University	marketed	Nucleoside analog antiviral	Viral RNA-dependent RNA polymerase (RdRp)

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