intravenous (IV) ganciclovir — Competitive Intelligence Brief

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

marketed Nucleoside analog antiviral Viral DNA polymerase (CMV and herpes simplex virus) Infectious Disease / Virology Small molecule

Target snapshot

intravenous (IV) ganciclovir (intravenous (IV) ganciclovir) — University of Oslo School of Pharmacy. Ganciclovir is a nucleoside analog that inhibits viral DNA polymerase, preventing replication of herpes viruses, particularly cytomegalovirus (CMV).

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
intravenous (IV) ganciclovir TARGET	intravenous (IV) ganciclovir	University of Oslo School of Pharmacy	marketed	Nucleoside analog antiviral	Viral DNA polymerase (CMV and herpes simplex virus)
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
Valganciclovir/Ganciclovir	Valganciclovir/Ganciclovir	University Health Network, Toronto	marketed	Nucleoside analog antiviral	Cytomegalovirus (CMV) DNA polymerase
Copegus (ribavirin)	Copegus (ribavirin)	Hoffmann-La Roche	marketed	Nucleoside analog antiviral	Viral RNA polymerase; IMPDH (inosine monophosphate dehydrogenase)
VAL	VAL	Estetra	marketed	Nucleoside analog antiviral	Cytomegalovirus (CMV) DNA polymerase
Sofosbuvir-Ribavirin	Sofosbuvir-Ribavirin	Ain Shams University	marketed	Nucleotide polymerase inhibitor + nucleoside analog antiviral	HCV NS5B RNA-dependent RNA polymerase; ribavirin has multiple targets

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