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TEMODAR

NDA

TEMOZOLOMIDE | N021029 | MERCK SHARP AND DOHME CORP

6 strengths0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

14 trials from ClinicalTrials.gov — 9 recruiting, 5 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Subventricular Zone (SVZ) and Temozolomide in Glioblastoma Multiforme NCT02177578	Phase 2	Active	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	60	2014-07-08 → 2027-08
Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma NCT00539591	Phase 2	Active	St. Jude Children's Research Hospital	29	2008-05-09 → 2031-05
Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma NCT03180502	Phase 2	Active	NRG Oncology	120	2018-01-23 → 2026-07-15
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
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
Pan Tumor Rollover Study NCT03899155	Phase 2	Recruiting	Bristol-Myers Squibb	1,500	2019-08-09 → 2029-08-25
Vortioxetine for Newly Diagnosed Glioblastoma NCT07284628	Phase 2	Recruiting	University of Zurich	78	2026-06-24 → 2029-06
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII NCT07326566	Phase 2	Recruiting	Black Diamond Therapeutics, Inc.	162	2026-05-05 → 2029-03
Safety and Effectiveness Evaluation of Temozolomide (Amitzo, NanoAlvand) in Patients With Grade III and IV Glioma Tumors NCT07675070	—	Recruiting	NanoAlvand	100	2026-03-22 → 2026-11
Medication Combinations of Dasatinib, Quercetin, Fisetin, Temozolomide, LMP744, and Autologous TLPO Vaccine for the Treatment of Previously Treated Glioma With Residual Disease NCT07025226	Early Phase 1	Recruiting	Mayo Clinic	30	2025-08-12 → 2027-09-01

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

Medicare Part B Spending

CMS physician-administered drug spending for Temodar (J8700) (2023)

Total Spending

$1.6M

Total Claims

27,054

Beneficiaries

5,480

ASP Price

—

Spending Trend

$1.6M(2023)→$311K(2023)

HCPCS: J8700 — Temozolomide, oral, 5 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain13 active DMFs1 inactive

13 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

EXCELLA GMBH AND CO KGTEMOZOLOMIDE

DMF 260322012

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

23 letters from Drugs@FDA

Date	Submission	Document
Sep 15, 2023	SUPPL -37	View Letter (PDF)
Sep 15, 2023	SUPPL -38	View Letter (PDF)
Sep 15, 2023	SUPPL -36	View Letter (PDF)
Nov 25, 2020	SUPPL -35	View Letter (PDF)
Nov 26, 2019	SUPPL -33	View Letter (PDF)
Oct 12, 2017	SUPPL -32	View Letter (PDF)
Mar 2, 2017	SUPPL -30	View Letter (PDF)
Feb 16, 2016	SUPPL -31	View Letter (PDF)
Sep 22, 2015	SUPPL -29	View Letter (PDF)
Apr 3, 2015	SUPPL -28	View Letter (PDF)
May 6, 2014	SUPPL -26	View Letter (PDF)
Jun 9, 2011	SUPPL -21	View Letter (PDF)
Apr 29, 2010	SUPPL -18	View Letter (PDF)
Oct 23, 2006	SUPPL -12	View Letter (PDF)
Apr 7, 2006	SUPPL -11	View Letter (PDF)
Apr 28, 2005	SUPPL -10	View Letter (PDF)
Mar 31, 2005	SUPPL -9	View Letter (PDF)
Mar 18, 2005	SUPPL -8	View Letter (PDF)
Jul 21, 2004	SUPPL -6	View Letter (PDF)
Jun 30, 2004	SUPPL -7	View Letter (PDF)
Mar 26, 2003	SUPPL -5	View Letter (PDF)
Jan 18, 2002	SUPPL -4	View Letter (PDF)
Aug 11, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 5MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 11, 1999

No patent or exclusivity listings for this strength.

#002 — 20MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 11, 1999

#003 — 100MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 11, 1999

#004 — 250MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 11, 1999

#005 — 140MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 19, 2006

#006 — 180MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 19, 2006