Temozolomide - Generic Drug Details

What are the generic drug sources for temozolomide and what is the scope of freedom to operate?

Temozolomide is the generic ingredient in two branded drugs marketed by Merck Sharp Dohme, Accord Hlthcare, Amneal Pharms, Ani Pharms, Apotex, Chartwell, Chartwell Molecular, Chemi Spa, Deva Holding As, Heritage, Hetero Labs Ltd V, Nivagen Pharms Inc, Rising, Sun Pharm, Watson Labs Teva, and Zydus Pharms, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for temozolomide. Twelve suppliers are listed for this compound.

Summary for temozolomide

US Patents:	0
Tradenames:	2
Applicants:	16
NDAs:	18
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	1,010
Patent Applications:	6,355
Drug Prices:	Drug price trends for temozolomide
What excipients (inactive ingredients) are in temozolomide?	temozolomide excipients list
DailyMed Link:	temozolomide at DailyMed

See drug prices for temozolomide

Recent Clinical Trials for temozolomide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rigel Pharmaceuticals	Phase 2
Zhongnan Hospital	Phase 1/Phase 2
CarThera	Phase 3

See all temozolomide clinical trials

Pharmacology for temozolomide

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for temozolomide

L01AX	Other alkylating agents
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for TEMOZOLOMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEMODAR	Capsules	temozolomide	140 mg and 180 mg	021029	1	2008-03-24
TEMODAR	Capsules	temozolomide	5 mg, 20 mg, 100 mg and 250 mg	021029	1	2007-03-20

US Patents and Regulatory Information for temozolomide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	201528-004	Feb 27, 2017	AB	RX	No	No
Rising	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	206309-002	Apr 27, 2016	AB	RX	No	No
Chemi Spa	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	204639-001	Nov 23, 2016	AB	RX	No	No
Sun Pharm	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	201742-006	Feb 12, 2014	AB	RX	No	No
Chartwell Molecular	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	203898-006	Feb 10, 2016		DISCN	No	No

Expired US Patents for temozolomide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-001	Aug 11, 1999
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-005	Oct 19, 2006
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-006	Oct 19, 2006
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009

EU/EMA Drug Approvals for temozolomide

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
medac Gesellschaft für klinische Spezialpräparate mbH	Temomedac	temozolomide	EMEA/H/C/001124 Temomedac hard capsules is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment;children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	Authorised	yes	no	no	2010-01-25
Accord Healthcare S.L.U.	Temozolomide Accord	temozolomide	EMEA/H/C/001125 For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	Authorised	yes	no	no	2010-03-15
Sun Pharmaceutical Industries Europe B.V.	Temozolomide Sun	temozolomide	EMEA/H/C/002198 Temozolomide Sun is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment;children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	Authorised	yes	no	no	2011-07-13
Teva B.V.	Temozolomide Teva	temozolomide	EMEA/H/C/001126 For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	Authorised	yes	no	no	2010-01-28
Merck Sharp & Dohme B.V.	Temodal	temozolomide	EMEA/H/C/000229 Temodal hard capsules is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment;children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	Authorised	no	no	no	1999-01-26