Sirolimus Oral Product — Competitive Intelligence Brief

Sirolimus Oral Product (Sirolimus Oral Product) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: mTOR inhibitor. Area: Immunology; Oncology.

marketed mTOR inhibitor mTOR (mammalian target of rapamycin) Immunology; Oncology Small molecule

Target snapshot

Sirolimus Oral Product (Sirolimus Oral Product) — Shanghai Children's Medical Center. Sirolimus inhibits mTOR (mammalian target of rapamycin), a key regulator of cell proliferation and immune cell activation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Sirolimus Oral Product TARGET	Sirolimus Oral Product	Shanghai Children's Medical Center	marketed	mTOR inhibitor	mTOR (mammalian target of rapamycin)
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
Tacrolimus and Everolimus	Tacrolimus and Everolimus	Chang Gung Memorial Hospital	marketed	Immunosuppressant (calcineurin inhibitor and mTOR inhibitor combination)	Calcineurin (tacrolimus) and mTOR (everolimus)
Neoral/Sirolimus	Neoral/Sirolimus	University of Miami	marketed	Calcineurin inhibitor + mTOR inhibitor combination	Calcineurin (cyclosporine); mTOR kinase (sirolimus)
Rapamune® (Sirolimus)	Rapamune® (Sirolimus)	Wyeth is now a wholly owned subsidiary of Pfizer	marketed	mTOR inhibitor	mTOR (mammalian target of rapamycin)
Percutaneous sirolimus	Percutaneous sirolimus	Children's Hospital of Fudan University	marketed	mTOR inhibitor	mTOR (mechanistic target of rapamycin)

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