Percutaneous sirolimus — Competitive Intelligence Brief

Percutaneous sirolimus (Percutaneous sirolimus) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: mTOR inhibitor. Area: Dermatology.

marketed mTOR inhibitor mTOR (mechanistic target of rapamycin) Dermatology Small molecule

Target snapshot

Percutaneous sirolimus (Percutaneous sirolimus) — Children's Hospital of Fudan University. Percutaneous sirolimus is a topical formulation of the immunosuppressant sirolimus delivered through the skin to inhibit mTOR signaling and suppress immune cell proliferation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Percutaneous sirolimus TARGET	Percutaneous sirolimus	Children's Hospital of Fudan University	marketed	mTOR inhibitor	mTOR (mechanistic 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)
Arm 1 Everolimus/Reduced dose tacrolimus	Arm 1 Everolimus/Reduced dose tacrolimus	University of Toledo Health Science Campus	marketed	mTOR inhibitor + Calcineurin inhibitor combination	mTOR; Calcineurin (PP2B)
Drug conversion to sirolimus	Drug conversion to sirolimus	Hospital do Rim e Hipertensão	marketed	mTOR inhibitor	mTOR (mammalian target of rapamycin)
Rapamune® (Sirolimus)	Rapamune® (Sirolimus)	Wyeth is now a wholly owned subsidiary of Pfizer	marketed	mTOR inhibitor	mTOR (mammalian 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