Drug: Everolimus — Competitive Intelligence Brief

Drug: Everolimus (Drug: Everolimus) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: mTOR inhibitor. Area: Oncology.

phase 3 mTOR inhibitor mTORC1 Oncology Small molecule

Target snapshot

Drug: Everolimus (Drug: Everolimus) — Grupo Espanol de Tumores Neuroendocrinos. Everolimus inhibits mTOR (mammalian target of rapamycin), a key protein kinase that regulates cell growth and proliferation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Drug: Everolimus TARGET	Drug: Everolimus	Grupo Espanol de Tumores Neuroendocrinos	phase 3	mTOR inhibitor	mTORC1
Everolimus Tablets	Everolimus Tablets	Shandong Suncadia Medicine Co., Ltd.	marketed	mTOR inhibitor	mTOR (mTORC1)
Everolimus (Afinitor®)	Everolimus (Afinitor®)	Odense University Hospital	phase 3	mTOR inhibitor	mTOR (mTORC1)
Everolimus (Afinitor) tablets	Everolimus (Afinitor) tablets	Exelixis	phase 3	mTOR inhibitor	mTOR (mTORC1)
AZD0486	AZD0486	AstraZeneca	phase 3	mTORC1 inhibitor	mTORC1
Rapamune	sirolimus	Pfizer	marketed	mTOR Inhibitor Immunosuppressant [EPC]	Serine/threonine-protein kinase mTOR	1999-01-01
SIROLIMUS	SIROLIMUS		marketed	mTOR Inhibitor Immunosuppressant [EPC]	mTOR	1999-01-01

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)

• 2029-02-14 — Rapamune · 8911786 · Formulation · US
• 2030-04-15 — Rapamune · 10206887 · Formulation · US
• 2036-03-05 — Rapamune · 12061183 · Formulation · US
• 2036-03-05 — Rapamune · 10705070 · Formulation · US
• 2036-06-29 — Rapamune · 10973806 · Method of Use · US
• 2036-06-29 — Rapamune · 12133844 · Method of Use · US
• 2040-10-28 — Rapamune · 11497737 · Formulation · US

Sponsor landscape (mTOR inhibitor class)

1. Chong Kun Dang Pharmaceutical · 2 drugs in this class
2. Wyeth is now a wholly owned subsidiary of Pfizer · 2 drugs in this class
3. Exelixis · 1 drug in this class
4. GlaxoSmithKline · 1 drug in this class
5. Grupo Espanol de Tumores Neuroendocrinos · 1 drug in this class
6. H. Lee Moffitt Cancer Center and Research Institute · 1 drug in this class
7. Hannover Medical School · 1 drug in this class
8. Hospital do Rim e Hipertensão · 1 drug in this class
9. ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · 1 drug in this class
10. Melanoma and Skin Cancer Trials Limited · 1 drug in this class