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TEMODAR

NDA

TEMOZOLOMIDE | N022277 | MERCK SHARP AND DOHME CORP

1 strength0 unique patents0 unique exclusivities

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

500 trials from ClinicalTrials.gov — 67 recruiting, 63 active, 306 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors NCT04337177	Phase 1	Active	Valent Technologies, LLC	20	2021-10-25 → 2026-12
Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma NCT04200443	Phase 2	Active	City of Hope Medical Center	96	2020-01-14 → 2026-09-10
Phase I Trial of DNA-PK Inhibitor (PEPOSERTIB ) in Combination With Radiation and Adjuvant Temozolomide in Newly Diagnosed MGMT Unmethylated and Recurrent Glioblastoma NCT04555577	Phase 1	Active	M.D. Anderson Cancer Center	29	2020-09-20 → 2027-12-31
Irinotecan, Temozolomide and Bevacizumab in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Newly Diagnosed Patients With Desmoplastic Small Round Cell Tumor NCT01189643	Early Phase 1	Active	Memorial Sloan Kettering Cancer Center	15	2010-08 → 2026-08
Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma NCT03794349	Phase 2	Active	Children's Oncology Group	94	2019-07-08 → 2029-03-31
Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas NCT00268385	Phase 1	Active	National Cancer Institute (NCI)	83	2005-12-16 → 2027-04-24
Lonafarnib and Temozolomide in Treating Patients with Glioblastoma Multiforme That is Recurrent or Did Not Respond to Previous Treatment with Temozolomide NCT00102648	Phase 1	Active	M.D. Anderson Cancer Center	34	2004-12-21 → 2025-12-01
A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma NCT06388733	Phase 3	Active	Ivy Brain Tumor Center	450	2024-06-19 → 2028-03
A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma NCT03880019	Phase 2	Active	National Cancer Institute (NCI)	23	2019-08-19 → 2026-11-12
Telaglenastat With Radiation Therapy and Temozolomide in Treating Patients With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma NCT03528642	Phase 1	Active	National Cancer Institute (NCI)	40	2019-05-01 → 2026-09-11

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$737.47

Highest Price

$987.99

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00085-1381-01TEMODAR 100MG VIAL,INJ	$737.47	Big4	Merck Sharp & Dohme LLC	05/31/2030
00085-1381-01TEMODAR 100MG VIAL,INJ	$987.99	FSS	Merck Sharp & Dohme LLC	05/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain15 active DMFs1 inactive

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

WAVELENGTH ENTERPRISES LTDTEMOZOLOMIDE

DMF 193472006

JIANGSU TASLY DIYI PHARMACEUTICAL CO LTDTEMOZOLOMIDE (BULK, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 216692008

RELIANCE LIFE SCIENCES PVT LTDTEMOZOLOMIDE USP

DMF 227752009

FORMOSA LABORATORIES INCTEMOZOLOMIDE

DMF 231582009

SHILPA PHARMA LIFESCIENCES LTDTEMOZOLOMIDE USP

DMF 234792010

CHEMWERTH INCTEMOZOLOMIDE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 235472010

SUN PHARMACEUTICAL INDUSTRIES LTDTEMOZOLOMIDE USP

DMF 235532010

GLOPEC INTERNATIONAL INCTEMOZOLOMIDE

DMF 241732010

SYNTHIMED LABS PRIVATE LTDTEMOZOLOMIDE USP

DMF 242982010

BEIJING LUNARSUN PHARMACEUTICAL CO LTDTEMOZOLOMIDE

DMF 243522010

HETERO LABS LTDTEMOZOLOMIDE, USP

DMF 253442011

EXCELLA GMBH AND CO KGTEMOZOLOMIDE

DMF 260322012

ITF CHEMICAL LTDATEMOZOLOMIDE, USP

DMF 265342012

HUBEI HAOSUN PHARMACEUTICAL CO LTDTEMOZOLOMIDE

DMF 277152013

AMPAC FINE CHEMICALS LLCTEMOZOLOMIDE

DMF 285802014

CIPLA LTDInactiveTEMOZOLOMIDE USP

DMF 290282015

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Sep 15, 2023	SUPPL -19	View Letter (PDF)
Sep 15, 2023	SUPPL -18	View Letter (PDF)
Sep 15, 2023	SUPPL -17	View Letter (PDF)
Nov 25, 2020	SUPPL -14	View Letter (PDF)
Nov 26, 2019	SUPPL -13	View Letter (PDF)
Oct 12, 2017	SUPPL -12	View Letter (PDF)
Mar 2, 2017	SUPPL -10	View Letter (PDF)
Feb 16, 2016	SUPPL -11	View Letter (PDF)
Sep 22, 2015	SUPPL -9	View Letter (PDF)
Apr 3, 2015	SUPPL -8	View Letter (PDF)
May 6, 2014	SUPPL -7	View Letter (PDF)
Jun 9, 2011	SUPPL -5	View Letter (PDF)
Apr 29, 2010	SUPPL -1	View Letter (PDF)
Mar 5, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/VIAL

RLD

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Feb 27, 2009

No patent or exclusivity listings for this strength.