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, Chemi Spa, Deva Holding As, Eirgen, Extrovis, 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. Ten suppliers are listed for this compound.

Summary for temozolomide

US Patents:	0
Tradenames:	2
Applicants:	17
NDAs:	18
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1,110
Patent Applications:	7,660
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
Canadian Cancer Trials Group	PHASE3
European Organisation for Research and Treatment of Cancer - EORTC	PHASE3
Cooperative Trials Group for Neuro-Oncology (COGNO)	PHASE3

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
Eirgen	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	203898-003	Feb 10, 2016	AB	RX	No	No
Zydus Pharms	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	206750-001	Jul 31, 2017	AB	RX	No	No
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-004	Aug 11, 1999		DISCN	Yes	No
Ani Pharms	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	203490-005	Jul 13, 2016		DISCN	No	No
Deva Holding As	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	207658-004	Apr 26, 2017	AB	RX	No	No
Nivagen Pharms Inc	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	213328-005	Nov 23, 2021		DISCN	No	No
Extrovis	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	205227-001	Jun 29, 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	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009	5,260,291*PED
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	6,987,108
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009	7,786,118
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-004	Aug 11, 1999	5,260,291*PED
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-005	Oct 19, 2006	5,260,291*PED
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009	8,623,868

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/001124Temomedac 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/001125For 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/002198Temozolomide 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/001126For 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/000229Temodal 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
Hexal AG	Temozolomide Hexal	temozolomide	EMEA/H/C/001127For 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.	Withdrawn	yes	no	no	2010-03-15
Sandoz GmbH	Temozolomide Sandoz	temozolomide	EMEA/H/C/001128For 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.	Withdrawn	yes	no	no	2010-03-15

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Temozolomide

Last updated: July 27, 2025

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Introduction

Temozolomide, marketed primarily under the brand name Temodar, is an oral alkylating chemotherapy agent used predominantly for the treatment of glioblastoma multiforme (GBM) and other malignant brain tumors. Since its initial approval, temozolomide has established itself as a cornerstone in neuro-oncology, catalyzing shifts in treatment paradigms and influencing the pharmaceutical landscape. This analysis explores the market dynamics influencing temozolomide’s growth and evaluates its projected financial trajectory amid evolving clinical, regulatory, and competitive environments.

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Market Overview and Current Landscape

Historical Market Context

Approved by the U.S. Food and Drug Administration (FDA) in 2005, temozolomide revolutionized the management of gliomas by offering an oral, well-tolerated, and effective chemotherapeutic option. Its integration into standard-of-care protocols, specifically concurrent with radiotherapy for GBM, propelled rapid adoption across developed markets, predominantly North America, Europe, and parts of Asia-Pacific.

Initial market uptake was fueled by limited alternatives for aggressive brain tumors and the drug’s demonstrated survival benefits. The patent held by Schering-Plough (later acquired by Merck) provided exclusivity through the early 2020s, creating a high-margin environment and incentivizing continued investment.

Current Market Size and Share

As of 2023, the global market for temozolomide is valued at approximately USD 600 million, with North America accounting for nearly 50% due to high prevalence and advanced healthcare infrastructure. Europe and Asia-Pacific contribute the remaining share, with emerging markets showing increased access and usage.

The drug’s revenue is driven predominantly by indications for glioblastoma and anaplastic astrocytoma. Off-label uses, such as certain neuroendocrine tumors, contribute marginally. The market is characterized by high drug adherence rates owing to its oral formulation, but faced with patent expirations and the advent of biosimilars, future revenue streams are under pressure.

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Market Dynamics Shaping Future Trajectory

Patent Expiration and Biosimilar Entry

The primary driver of anticipated revenue decline is the impending expiration of key patents, expected between 2023 and 2026. The patent cliff has catalyzed the entry of biosimilar and generic versions, reducing prices by up to 40%. Major pharmaceutical companies are preparing for this transition, with some low-cost entrants already available in select markets, intensifying competition and eroding profit margins.

Regulatory Developments and Off-Label Approvals

Regulatory bodies are increasingly scrutinizing off-label claims, emphasizing evidence-based indications. While temozolomide's primary indications remain approved, ongoing clinical trials investigating its efficacy in other cancers, such as melanoma and certain leukemias, may expand or restrict its scope, influencing sales accordingly. Additionally, the approval of combination therapies incorporating temozolomide continues to evolve, potentially affecting its market positioning.

Emerging Therapies and Treatment Paradigm Shifts

Innovations in neuro-oncology threaten to displace monotherapy with combination or immunotherapy-based regimens. Trials such as CheckMate 548 and those investigating tumor-treating fields (TTFields) aim for survival improvements, possibly reducing reliance on temozolomide in standard protocols. The advent of targeted therapies and immuno-oncology agents, like nivolumab and pembrolizumab, pose competitive threats and may impact sales volumes.

Patient Demographics and Disease Prevalence

The rising incidence of gliomas, driven by aging populations and increased diagnostic capabilities, sustains demand. According to the Central Brain Tumor Registry of the United States (CBTRUS), GBM incidence is approximately 3.2 cases per 100,000 annually, with demographic shifts potentially increasing it further.

Pricing and Reimbursement Policies

Healthcare payer pressure for cost containment affects drug pricing. Managed care organizations and government payers are negotiating for discounts and formulary exclusions, especially post-patent expiry. Value-based pricing models and risk-sharing agreements are emerging, influencing revenue streams.

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Financial Trajectory and Outlook

Short-Term Predictions (2023-2025)

In the immediate future, revenues are expected to plateau or decline modestly due to patent expiration and the rise of generics. However, existing inventory and continued use in approved indications will sustain stable cash flows for a period. The shift towards biosimilar adoption might trigger price reductions, diminishing profit margins substantially.

Medium- to Long-Term Outlook (2026-2030)

Post-patent, the market will witness heightened competition with generic and biosimilar versions capturing significant market share. Price erosion could reach 50-60%, impacting top-line revenues unless offset by volume increases or new indications.

Simultaneously, orphan drug designations and expanded indications, such as recurrent gliomas or combination treatments under development, could provide alternative revenue streams. Merck and other pharmaceutical stakeholders are investing in clinical programs to extend the drug’s lifecycle through innovative delivery systems and companion diagnostics.

Projected Revenue Trends

Industry analysts forecast a decline in global temozolomide sales by approximately 35-45% over the next five years, contingent on patent expiries and biosimilar market penetration. Nonetheless, the drug's role as a standard-of-care in newly diagnosed GBM ensures a baseline demand in markets where it remains reimbursed and preferred.

Impact of Pricing Strategies and Market Penetration

Adapting to market pressures, pharmaceutical companies are deploying volume-based strategies, negotiating rebates, and exploring tiered pricing models in lower-income regions. These approaches aim to preserve market share amid competition, albeit with reduced margins.

Additionally, licensing agreements and strategic alliances with local manufacturers facilitate access and mitigate supply chain risks.

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Strategic Considerations for Stakeholders

• Pharmaceutical Manufacturers: Invest in pipeline augmentation, including combination therapies and novel delivery platforms, to prolong market relevance.

• Investors and Business Analysts: Focus on developing alternative revenue models, emphasizing pipeline expansion, and monitoring biosimilar trends.

• Healthcare Providers: Optimize prescribing practices by considering cost-effectiveness, especially as generics become more prevalent.

• Regulatory Bodies: Streamline approval pathways for innovative formulations and combinatory regimens that could impact the traditional role of temozolomide.

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Key Takeaways

• Market Maturity and Competition: Temozolomide’s patent expiration triggers significant brand erosion, opening markets for biosimilars and generics, which substantially reduce revenues and profit margins.

• Revenue Declines Forecasted: Industry projections indicate a 35-45% sales decline over the next five years, driven by increased competition and pricing pressures.

• Pipeline and Indication Expansion: Ongoing clinical trials and new combination regimes are crucial for maintaining relevance and creating alternative revenue streams.

• Pricing and Access Strategies: Sophisticated pricing models, including value-based agreements, are critical for optimizing market presence in price-sensitive regions.

• Market Adaptability: Stakeholders must pivot toward innovation, licensing agreements, and broader indications to sustain financial viability.

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FAQs

1. When is the patent for temozolomide expiring, and what does that mean for its market?
The primary patents for temozolomide are set to expire between 2023 and 2026. This expiration allows biosimilar and generic manufacturers to enter the market, intensifying competition, reducing prices, and potentially decreasing brand-name sales.

2. How are biosimilars expected to impact temozolomide’s revenue?
Biosimilars are projected to capture a substantial market share, leading to significant price reductions—potentially up to 50-60%. This shift is expected to diminish the profitability of innovator companies and reshape the market landscape.

3. What emerging therapies could replace or complement temozolomide?
Immuno-oncology agents like PD-1 inhibitors, tumor-treating fields, and targeted therapies are under clinical investigation. Successful development of these options could reduce reliance on temozolomide as a first-line treatment.

4. Are there ongoing efforts to expand temozolomide’s indications?
Yes. Clinical trials are exploring its efficacy in other tumors, such as metastatic melanoma and certain leukemias, with potential for indication expansion, which could mitigate revenue loss from generics.

5. How can pharmaceutical companies mitigate revenue decline post-patent expiry?
Strategies include developing combination therapies, innovating delivery methods, securing new indications, engaging in licensing and partnerships, and implementing value-based pricing models.

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Sources:

[1] CBTRUS. Central Brain Tumor Registry of the United States, 2021.
[2] IMS Health Data. Global Oncology Market Analysis, 2022.
[3] U.S. FDA. Temozolomide Approval and Regulatory Information, 2005.
[4] Industry Reports. Biosimilar Impact on Cancer Therapies, 2022.
[5] ClinicalTrials.gov. Ongoing trials involving Temozolomide, 2023.