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:	6,570
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
Amneal Pharms	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	203691-003	May 8, 2015	AB	RX	No	No
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009		RX	Yes	Yes
Watson Labs Teva	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	203959-001	Apr 18, 2017		DISCN	No	No
Nivagen Pharms Inc	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	213328-005	Nov 23, 2021		DISCN	No	No
Hetero Labs Ltd V	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	210030-005	Aug 23, 2024	AB	RX	No	No

Expired US Patents for temozolomide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009	8,623,868
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-006	Oct 19, 2006	5,260,291*PED
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009	7,786,118
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-001	Aug 11, 1999	5,260,291*PED
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009	5,260,291*PED

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

Temozolomide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Temozolomide

Introduction to Temozolomide

Temozolomide, also known as Temodal, is a chemotherapy drug belonging to the class of alkylating agents. It is primarily used to treat certain types of brain tumors, including low-grade and high-grade gliomas. Temozolomide works by preventing cancer cells from making DNA, thereby inhibiting their ability to divide and grow[1].

Market Overview

The global Temozolomide market has shown significant growth in recent years. As of 2022, the market value was USD 8593.27 million, and it is projected to reach USD 9705.2 million by 2028, exhibiting a Compound Annual Growth Rate (CAGR) of 2.05% during the forecast period[1].

Impact of COVID-19

The COVID-19 pandemic had a notable impact on the Temozolomide market. The global supply chain was disrupted due to reduced international shipping, increased transportation costs, and various restrictive measures adopted by countries. This led to a decrease in foreign orders and exacerbated the survival crisis of export enterprises. However, as the pandemic eased, pharmaceutical companies resumed normal operations, which is expected to promote market growth in the coming years[1].

Strengths and Opportunities

Strengths

• Temozolomide is currently the most effective drug for treating low-grade and high-grade gliomas.
• It has a huge potential market due to the increasing prevalence of neurological diseases worldwide.
• The drug has a rich downstream industry, including hospitals, clinics, and other healthcare facilities[1].

Opportunities

• Technological innovation in drug delivery and formulation is expected to enhance the market.
• Industrial integration and the update of products can further expand the market share.
• The growing prevalence of neurological diseases globally presents a significant opportunity for growth[1].

Weaknesses and Threats

Weaknesses

• Temozolomide has several side effects, including nausea, vomiting, constipation, loss of appetite, hair loss, headache, fatigue, and convulsions.
• These side effects can impact patient compliance and overall market demand[1].

Threats

• The market faces competition from other chemotherapy drugs and emerging treatments.
• Regulatory changes and pricing pressures can also pose threats to the market[1].

Segmentation Overview

By Type

The Temozolomide market is primarily segmented into Temozolomide Capsules and Temozolomide Injection. The Temozolomide Injection segment is anticipated to contribute the largest market share by 2027[1].

By Downstream Industry

The market is segmented into hospitals, clinics, and other healthcare facilities. Hospitals are expected to dominate this segment due to the high demand for Temozolomide in treating brain tumors[1].

Geographical Analysis

The global Temozolomide market is geographically segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The Asia Pacific region had the highest growth rate among all regions, driven by increasing healthcare expenditure and a growing patient population[1].

Key Companies

Major players in the Temozolomide market include Merck & Co, Tianjin Tasly Pharmaceutical Co, Sun Pharma, SL PHARM, and Teva Pharmaceutical Industries. Merck & Co holds a significant market share, accounting for 23.92% in 2022[1].

Financial Performance and Projections

The global Temozolomide market has demonstrated steady financial growth. Here are some key financial metrics:

• Market Value: The market value was USD 8593.27 million in 2022 and is projected to reach USD 9705.2 million by 2028[1].
• CAGR: The market is expected to grow at a CAGR of 2.05% during the forecast period[1].
• Revenue Share: Merck & Co, one of the major players, holds a significant revenue share, indicating a strong market presence[1].

Cost-Effectiveness and Economic Impact

Temozolomide has been evaluated for its cost-effectiveness in various studies. Despite being at the higher end of commonly accepted thresholds, the incremental cost-effectiveness of Temozolomide as an adjuvant treatment aligns with other accepted cancer treatments. This suggests that while it is expensive, it provides significant benefits in terms of patient survival and quality of life[3].

Clinical Efficacy and Safety

Clinical studies have consistently shown the efficacy of Temozolomide in treating brain tumors. For example, a retrospective cohort study demonstrated that the combination of radiotherapy, Temozolomide, and Nimotuzumab improved progression-free survival (PFS) and overall survival (OS) in patients with newly diagnosed EGFR-positive glioblastoma[2].

Research and Development

The research landscape for Temozolomide is extensive, with over 12,910 publications from 1994 to 2021, involving 104 nations, 9,949 institutions, and 49,458 authors. The focus of these studies includes resistance mechanisms, clinical trials, and specific aspects of Temozolomide treatment[5].

Market Trends and Drivers

• Technological Innovations: Advances in drug delivery formulations and technologies are driving the market.
• Increasing Prevalence of Neurological Diseases: The growing incidence of brain tumors and other neurological diseases is a significant driver.
• Industrial Integration: Mergers and acquisitions, such as Mayne Pharma's acquisition of generic pharmaceutical products from Teva, are expanding market opportunities[1].

Challenges and Restraints

• Side Effects: The drug's side effects can impact patient compliance and market demand.
• Regulatory Pressures: Changes in regulatory policies and pricing pressures can pose challenges to the market.
• Competition: Emerging treatments and other chemotherapy drugs compete with Temozolomide for market share[1].

Key Takeaways

• The global Temozolomide market is valued at USD 8593.27 million in 2022 and is projected to grow at a CAGR of 2.05% until 2028.
• The drug is highly effective for treating low-grade and high-grade gliomas but comes with significant side effects.
• Technological innovations, industrial integration, and the increasing prevalence of neurological diseases are key drivers of the market.
• Major players like Merck & Co dominate the market, with a significant revenue share.
• The Asia Pacific region is expected to have the highest growth rate among all regions.

Frequently Asked Questions (FAQs)

1. What is Temozolomide used for?

Temozolomide is used to treat certain types of brain tumors, including low-grade and high-grade gliomas.

2. How does Temozolomide work?

Temozolomide works by preventing cancer cells from making DNA, thereby inhibiting their ability to divide and grow.

3. What are the side effects of Temozolomide?

Common side effects include nausea, vomiting, constipation, loss of appetite, hair loss, headache, fatigue, and convulsions.

4. Which region is expected to dominate the Temozolomide market?

The Asia Pacific region is expected to have the highest growth rate among all regions.

5. What is the projected market value of Temozolomide by 2028?

The market is projected to reach USD 9705.2 million by 2028.

Cited Sources:

1. Global Temozolomide Market Research Report 2023-Competitive Analysis, Status and Outlook by Type, Downstream Industry, and Geography, Forecast to 2029. MarketResearch.com.
2. Radiotherapy Plus Temozolomide With or Without Nimotuzumab for Newly Diagnosed EGFR-Positive Glioblastoma: A Retrospective Cohort Study. Academic.oup.com.
3. The economics of temozolomide in brain cancer. PubMed.
4. Temozolomide Market Report 2024 (Global Edition). Cognitivemarketresearch.com.
5. A bibliometric and visualization-based analysis of temozolomide research hotspots and frontier evolution. Frontiersin.org.