Masked Oral Valacyclovir — Competitive Intelligence Brief

Masked Oral Valacyclovir (Masked Oral Valacyclovir) 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 (HSV and VZV) Infectious Disease / Virology Small molecule

Target snapshot

Masked Oral Valacyclovir (Masked Oral Valacyclovir) — NYU Langone Health. Masked oral valacyclovir is a taste-masked formulation of valacyclovir that inhibits viral DNA polymerase to prevent herpes simplex virus and varicella-zoster virus replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Masked Oral Valacyclovir TARGET	Masked Oral Valacyclovir	NYU Langone Health	marketed	Nucleoside analog antiviral	Viral DNA polymerase (HSV and VZV)
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
Ribavirin in Arm 1	Ribavirin in Arm 1	MinaPharm Pharmaceuticals	marketed	Nucleoside analog antiviral	Viral RNA polymerase; IMPDH (inosine monophosphate dehydrogenase)
ribavirin pre-treatment	ribavirin pre-treatment	University of Roma La Sapienza	marketed	Nucleoside analog antiviral	Viral RNA-dependent RNA polymerase; guanosine triphosphate metabolism
valganciclovir [Valcyte]	valganciclovir [Valcyte]	Hoffmann-La Roche	marketed	Nucleoside analog antiviral	Cytomegalovirus (CMV) DNA polymerase
Ribavirin (Copegus®)	Ribavirin (Copegus®)	Vertex Pharmaceuticals Incorporated	marketed	Nucleoside analog antiviral	Viral RNA-dependent RNA polymerase; inosine monophosphate dehydrogenase (IMPDH)

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