Sirolimus Tab. — Competitive Intelligence Brief

Sirolimus Tab. (Sirolimus Tab.) 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 Tab. (Sirolimus Tab.) — Chong Kun Dang Pharmaceutical. Sirolimus inhibits mTOR (mammalian target of rapamycin), a key signaling protein that controls cell growth and proliferation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Sirolimus Tab. TARGET	Sirolimus Tab.	Chong Kun Dang Pharmaceutical	marketed	mTOR inhibitor	mTOR (mammalian target of rapamycin)
SIROLIMUS	SIROLIMUS		marketed	mTOR Inhibitor Immunosuppressant [EPC]	mTOR	1999-01-01
Rapamune	sirolimus	Pfizer	marketed	mTOR Inhibitor Immunosuppressant [EPC]	Serine/threonine-protein kinase mTOR	1999-01-01
Neoral/Sirolimus	Neoral/Sirolimus	University of Miami	marketed	Calcineurin inhibitor + mTOR inhibitor combination	Calcineurin (cyclosporine); mTOR kinase (sirolimus)
Sirolimus + Maraviroc	Sirolimus + Maraviroc	University of Maryland, Baltimore	marketed	mTOR inhibitor + CCR5 antagonist combination	mTOR; CCR5
Rapamune® (Sirolimus)	Rapamune® (Sirolimus)	Wyeth is now a wholly owned subsidiary of Pfizer	marketed	mTOR inhibitor	mTOR (mammalian target of rapamycin)
Tacrolimus/Sirolimus	Tacrolimus/Sirolimus	University of Miami	marketed	Calcineurin inhibitor and mTOR inhibitor combination	Calcineurin (tacrolimus) and mTOR (sirolimus)

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