Valganciclovir/Ganciclovir — Competitive Intelligence Brief

Valganciclovir/Ganciclovir (Valganciclovir/Ganciclovir) 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/Ganciclovir (Valganciclovir/Ganciclovir) — University Health Network, Toronto. Valganciclovir is a prodrug that is converted to ganciclovir, which inhibits viral DNA polymerase to prevent cytomegalovirus (CMV) replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Valganciclovir/Ganciclovir TARGET	Valganciclovir/Ganciclovir	University Health Network, Toronto	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
intravenous (IV) ganciclovir	intravenous (IV) ganciclovir	University of Oslo School of Pharmacy	marketed	Nucleoside analog antiviral	Viral DNA polymerase (CMV and herpes simplex virus)
VAL	VAL	Estetra	marketed	Nucleoside analog antiviral	Cytomegalovirus (CMV) DNA polymerase
Experimental: Valacyclovir treatment	Experimental: Valacyclovir treatment	University of Pittsburgh	marketed	Nucleoside analog antiviral	Herpesvirus DNA polymerase
Peg-IFN + WB RBV for 24 weeks	Peg-IFN + WB RBV for 24 weeks	National Taiwan University Hospital	marketed	Immunomodulator + 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