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TORISEL

NDA

TEMSIROLIMUS | N022088 | PF PRISM CV

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expired (1)Active (1)TodayPED (+6 mo)

2026

2027

2028

2029

2030

2031

2032

2033

Today

8026276

Jul. 20, 2026

8791097

Nov. 10, 2032

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Sandoz Inc. 1:2012cv00654 1 patentANDA 203140, 203216Temsirolimus	D. Del.	2012-05-24	Terminated 2013-12-18	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

12 trials from ClinicalTrials.gov — 10 recruiting, 2 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Itacitinib + Everolimus in Hodgkin Lymphoma NCT03697408	Phase 1/2	Active	University of Pennsylvania	23	2019-02-11 → 2027-06
Everolimus Aging Study NCT05835999	Phase 2	Active	University of Wisconsin, Madison	106	2023-03-24 → 2026-09
Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains NCT07436611	Phase 2	Not Yet Recruiting	AFT Pharmaceuticals, Ltd.	30	2026-08 → 2027-10
A Phase 2 Study of the Safety and Efficacy of AV078 in Participants With Tuberous Sclerosis Complex (TSC) Refractory Epilepsy NCT07680322	Phase 2	Not Yet Recruiting	Aeovian Pharmaceuticals, Inc.	42	2026-09-01 → 2027-12-21
Ventricular mTOR Inhibition to Prevent Hydrocephalus After Brain Hemorrhage NCT07662174	Phase 1/2	Not Yet Recruiting	Massachusetts General Hospital	15	2027-01-01 → 2027-12-31
Topical TOR-582 Treatment of Epistaxis in HHT NCT07667413	Phase 1	Recruiting	Columbia University	27	2026-07 → 2027-05
Combination Therapy for the Treatment of Diffuse Midline Gliomas NCT05009992	Phase 2	Recruiting	University of California, San Francisco	360	2021-10-20 → 2029-06-30
Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial NCT05773274	Phase 2	Recruiting	National Cancer Institute (NCI)	100	2024-01-12 → 2029-04-30
Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia NCT06722586	Phase 4	Recruiting	Peking University First Hospital	84	2025-01-07 → 2027-12
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer NCT05573126	Phase 1/2	Recruiting	Ellipses Pharma	95	2023-01-11 → 2028-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain4 active DMFs2 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

CONCORD BIOTECH LTDTEMSIROLIMUS

DMF 249212011

SANDOZ GMBHTEMSIROLIMUS

DMF 249642011

SUN PHARMACEUTICAL INDUSTRIES LTDTEMSIROLIMUS

DMF 268252013

SHANDONG NEW TIME PHARMACEUTICAL CO LTDTEMSIROLIMUS

DMF 400812025

FRESENIUS KABI ONCOLOGY LTDInactiveTEMSIROLIMUS

DMF 260192012

BIOCON LTDInactiveTEMSIROLIMUS

DMF 288412015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Mar 29, 2018	SUPPL -21	View Letter (PDF)
Mar 29, 2018	SUPPL -23	View Letter (PDF)
May 24, 2017	SUPPL -20	View Letter (PDF)
Jul 28, 2016	SUPPL -19	View Letter (PDF)
Feb 27, 2015	SUPPL -18	View Letter (PDF)
Oct 9, 2014	SUPPL -17	View Letter (PDF)
Apr 8, 2014	SUPPL -16	View Letter (PDF)
Jun 4, 2012	SUPPL -14	View Letter (PDF)
Jun 27, 2011	SUPPL -5	View Letter (PDF)
Jun 27, 2011	SUPPL -4	View Letter (PDF)
Jun 27, 2011	SUPPL -7	View Letter (PDF)
Jun 27, 2011	SUPPL -12	View Letter (PDF)
Jun 27, 2011	SUPPL -2	View Letter (PDF)
Jun 27, 2011	SUPPL -10	View Letter (PDF)
Jul 14, 2010	SUPPL -8	View Letter (PDF)
Apr 29, 2010	SUPPL -6	View Letter (PDF)
Nov 19, 2007	SUPPL -1	View Letter (PDF)
Jun 4, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG/ML (25MG/ML)

RLDAP

2 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 30, 2007

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8026276	Jan 20, 2026PED: Jul 20, 2026	PED	—	Yes	—	—
8791097	May 10, 2032PED: Nov 10, 2032	PED	—	—		—