Drug conversion to sirolimus — Competitive Intelligence Brief

Drug conversion to sirolimus (Drug conversion to sirolimus) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: mTOR inhibitor. Area: Immunology / Transplantation.

marketed mTOR inhibitor mTOR (mammalian target of rapamycin) Immunology / Transplantation Small molecule

Target snapshot

Drug conversion to sirolimus (Drug conversion to sirolimus) — Hospital do Rim e Hipertensão. Sirolimus is an mTOR inhibitor that suppresses T-cell proliferation and immune activation to prevent organ rejection.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Drug conversion to sirolimus TARGET	Drug conversion to sirolimus	Hospital do Rim e Hipertensão	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
sirolimus (drug), mmf (drug)	sirolimus (drug), mmf (drug)	University Hospital Muenster	marketed	Immunosuppressive agents (mTOR inhibitor + IMPDH inhibitor combination)	mTOR (sirolimus); IMPDH type II (MMF)
rituximab and everolimus	rituximab and everolimus	National Taiwan University Hospital	marketed	Monoclonal antibody + mTOR inhibitor combination	CD20 (rituximab); mTOR (everolimus)
Percutaneous sirolimus	Percutaneous sirolimus	Children's Hospital of Fudan University	marketed	mTOR inhibitor	mTOR (mechanistic 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