Licensed quadrivalent HPV vaccine, Gardasil — Competitive Intelligence Brief

Licensed quadrivalent HPV vaccine, Gardasil (Licensed quadrivalent HPV vaccine, Gardasil) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Prophylactic vaccine. Area: Oncology / Immunology.

phase 3 Prophylactic vaccine Human papillomavirus (HPV) types 6, 11, 16, 18 Oncology / Immunology Small molecule

Target snapshot

Licensed quadrivalent HPV vaccine, Gardasil (Licensed quadrivalent HPV vaccine, Gardasil) — Murdoch Childrens Research Institute. Gardasil is a quadrivalent vaccine that stimulates the immune system to produce antibodies against four types of human papillomavirus (HPV types 6, 11, 16, and 18).

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Licensed quadrivalent HPV vaccine, Gardasil TARGET	Licensed quadrivalent HPV vaccine, Gardasil	Murdoch Childrens Research Institute	phase 3	Prophylactic vaccine	Human papillomavirus (HPV) types 6, 11, 16, 18
Human Papillomavirus	Human Papillomavirus	Peking Union Medical College Hospital	marketed	Prophylactic vaccine	Human Papillomavirus capsid protein (L1)
HPV vaccine	HPV vaccine	Fondazione IRCCS Policlinico San Matteo di Pavia	marketed	Prophylactic vaccine	Human papillomavirus (HPV) capsid proteins / L1 antigen
Recombinant Human Papillomavirus Bivalent Vaccine	Recombinant Human Papillomavirus Bivalent Vaccine	National Cancer Institute (NCI)	marketed	Prophylactic vaccine	Human papillomavirus types 16 and 18 (HPV-16, HPV-18)
Flu Vaccine	Flu Vaccine	La Fundacion Favaloro para la Investigacion y la Docencia Medica	marketed	Prophylactic vaccine	Influenza A and B viral hemagglutinin and neuraminidase surface antigens
Cervarix TM	Cervarix TM	GlaxoSmithKline	phase 3	Prophylactic vaccine	HPV types 16 and 18 (L1 capsid protein)
GSK580299 (Cervarix)	GSK580299 (Cervarix)	GlaxoSmithKline	phase 3	Prophylactic vaccine	HPV type 16 and 18 L1 capsid protein

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)

No upcoming patent expiries for this set.

Sponsor landscape (Prophylactic vaccine class)

1. GlaxoSmithKline · 5 drugs in this class
2. La Fundacion Favaloro para la Investigacion y la Docencia Medica · 1 drug in this class
3. Fondazione IRCCS Policlinico San Matteo di Pavia · 1 drug in this class
4. National Cancer Institute (NCI) · 1 drug in this class
5. Peking Union Medical College Hospital · 1 drug in this class
6. Shanghai Zerun Biotechnology Co.,Ltd · 1 drug in this class
7. Murdoch Childrens Research Institute · 1 drug in this class