TEMODAR Drug Patent Profile

Which patents cover Temodar, and when can generic versions of Temodar launch?

Temodar is a drug marketed by Merck Sharp Dohme and is included in two NDAs.

The generic ingredient in TEMODAR is temozolomide. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the temozolomide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Temodar

A generic version of TEMODAR was approved as temozolomide by SUN PHARM on February 12^th, 2014.

Summary for TEMODAR

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	304
Patent Applications:	5,820
Drug Prices:	Drug price information for TEMODAR
What excipients (inactive ingredients) are in TEMODAR?	TEMODAR excipients list
DailyMed Link:	TEMODAR at DailyMed

See drug prices for TEMODAR

Recent Clinical Trials for TEMODAR

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

Sponsor	Phase
St. Jude Children's Research Hospital	Phase 1/Phase 2
Xynomic Pharmaceuticals, Inc.	Phase 1
Orbus Therapeutics, Inc.	Phase 1

See all TEMODAR clinical trials

Pharmacology for TEMODAR

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Paragraph IV (Patent) Challenges for TEMODAR

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 TEMODAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-001	Aug 11, 1999		DISCN	Yes	No
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009		RX	Yes	Yes
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-005	Oct 19, 2006		DISCN	Yes	No
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-002	Aug 11, 1999		DISCN	Yes	No
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-003	Aug 11, 1999		DISCN	Yes	No
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-004	Aug 11, 1999		DISCN	Yes	No

Expired US Patents for TEMODAR

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

EU/EMA Drug Approvals for TEMODAR

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

International Patents for TEMODAR

See the table below for patents covering TEMODAR around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2008031186	PHARMACEUTICAL FORMULATION OF ANTINEOPLASTIC AGENT, IN PARTICULAR TEMOZOLOMIDE, PROCESSES OF MAKING AND USING THE SAME
Singapore	161101	PHARMACEUTICAL FORMULATIONS OF ANTINEOPLASTIC AGENTS, IN PARTICULAR TEMOZOLOMIDE PROCESSES OF MAKING AND USING THE SAME
Austria	397440
South Korea	100970528
African Intellectual Property Organization (OAPI)	7174
Finland	822921

Market Dynamics and Financial Trajectory for TEMODAR (Temozolomide)

Last updated: November 20, 2025

Introduction

Temozolomide (brand name: Temodar, also marketed as TEMODAR in various regions) remains a pivotal chemotherapeutic agent primarily indicated for glioblastoma multiforme (GBM) and certain other brain tumors. As the oncology landscape shifts with emerging therapies and precision medicine, understanding the market dynamics and financial trajectory of TEMODAR is critical for stakeholders—including pharmaceutical companies, investors, healthcare providers, and policymakers. This analysis explores the current market environment, competitive landscape, regulatory influences, and future growth prospects of TEMODAR.

Historical Context and Therapeutic Profile

Temozolomide, an oral alkylating agent, was approved by the U.S. Food and Drug Administration (FDA) in 1999 for the treatment of glioblastoma multiforme and anaplastic astrocytoma. Its mechanism involves methylation at the O6 position of guanine, inducing DNA damage and apoptosis. The drug’s ease of administration and favorable side effect profile contributed to its widespread adoption in neuro-oncology.

The drug’s patent expired in most markets around 2015–2017, initiating a period of generic entry that significantly impacted its market dynamics and pricing strategies.

Market Size and Volume Trends

Pre-Generic Era

Prior to patent expiry, TEMODAR’s sales were driven by high demand for GBM treatment, a highly aggressive and difficult-to-treat cancer. The drug commanded premium pricing, which translated into robust revenues for patent holders and key manufacturers like Merck KGaA and others. Globally, the market size peaked around $500 million annually, driven by a limited pool of eligible patients and high treatment costs.

Post-Patent Expiry and Generic Competition

Following patent expiration, a surge of generic versions entered markets across multiple countries, sparking significant price reductions—up to 60–70% in some markets. This led to a sharp decline in revenue, although volume sales increased due to wider accessibility. The net effect is a flattened or declining market value but with increased market penetration and affordability.

In emerging markets, the availability of generic TEMODAR has expanded access, fueling growth in terms of patient numbers but compressing margins for original manufacturers.

Current Market Outlook (2023-2028)

The global TEMODAR market is projected to stabilize at around $200–$300 million annually, with regional variations influenced by healthcare infrastructure, approval status for new indications, and reimbursement policies. The Asia-Pacific region is expected to witness the fastest growth due to increasing cancer prevalence and expanding healthcare facilities.

Clinical and Regulatory Dynamics

Emerging Therapeutic Alternatives

The chemotherapy landscape is increasingly competitive, with several novel agents and targeted therapies entering the scene. Tumor-treating fields (TTFields), immunotherapy, and precision medicines like molecular inhibitors are gradually encroaching on TEMODAR’s indications, particularly for GBM.

Regulatory Factors

Regulators are emphasizing evidence of improved survival and quality of life. Recent approvals for combination treatments incorporating TEMODAR—or for use in different tumor entities—could impact its market size. Moreover, approvals of biosimilars and generics have further intensified price competition.

Regulatory Challenges and Opportunities

• Increased scrutiny on pricing and cost-effectiveness in regions like Europe and North America.
• Expansion of approved indications (e.g., recurrent brain tumors, other solid tumors) offers potential for revenue growth.
• Potential for international expansion where approval is pending.

Competitive Landscape

Original Brand vs. Generics

Post-patent expiry, generic manufacturers such as Mylan, Teva, and Sun Pharmaceutical have launched their versions, competing primarily on price. While the generics account for the majority of volume, branded formulations still maintain a foothold through physician preferences and brand recognition.

Emerging Therapies

Therapeutic innovations—such as immune checkpoint inhibitors and personalized vaccines—pose long-term threats by offering alternative, potentially superior, treatment options for GBM patients.

Market Strategies

• Pricing: Generics have sharply driven prices downward; original manufacturers focus on value differentiation and broader indications.
• Distribution: Expansion into emerging markets is facilitated through partnerships with regional distributors and local healthcare reforms.
• Clinical Trials: Ongoing research into combinatorial regimens could influence future sales and market share.

Financial Trajectory

Historical Revenue Patterns

Pre-patent period: Substantial revenues via high-priced formulations; post-patent: revenues declined sharply, stabilizing at lower levels due to generic competition.

Forecasted Revenue Streams (2023–2028)

• Stable sales in established markets driven by ongoing use in first-line GBM.
• Potential uptick due to expanded indications or combination protocols.
• Impact of biosimilar and generic entries: Profit margins are expected to remain compressed; however, volume benefits partially offset decreased per-unit profit.

Investment and R&D Trends

Pharmaceutical firms may redirect R&D investments toward next-generation therapies, potentially impacting the development pipeline for TEMODAR-specific innovations.

Key Market Drivers and Challenges

Drivers

• Increasing glioblastoma prevalence due to aging populations.
• Growing acceptance of oral chemotherapies.
• Expanded indications and combination treatments.

Challenges

• Intense price competition from generics.
• Competition from cutting-edge therapies with superior efficacy.
• Regulatory pressures on drug pricing and reimbursement.

Future Outlook and Growth Opportunities

Though the patent landscape constrains exclusivity, several avenues exist for TEMODAR’s continued relevance:

• Combination approaches: Using TEMODAR with immunotherapies or targeted agents may enhance efficacy.
• Expanded indications: Investigations into other tumor types could unlock new markets.
• Biomarker-driven personalization: Tailoring treatments based on methylguanine-DNA methyltransferase (MGMT) methylation status could improve clinical outcomes and justify premium pricing in certain niches.

Furthermore, the advent of biosimilars and advanced formulations (e.g., long-acting versions) may influence the competitive landscape over the next decade.

Conclusion

The market dynamics for TEMODAR reflect a classic lifecycle progression from high-margin original drug to commoditized generic product, compounded by competitive innovations in oncology. While revenues have declined from historical peaks, ongoing clinical use, expanding indications, and regional market penetration sustain its relevance. The financial trajectory hinges on strategic adaptations—such as combination therapies, geographic expansion, and value-based care—that could buffer against generic price erosion and sustain demand.

Overall, stakeholders must navigate the complex interplay of clinical advances, regulatory environments, and market forces to optimize the value of TEMODAR in the evolving landscape of cancer therapeutics.

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Key Takeaways

• The expiration of TEMODAR’s patent led to a significant decline in per-unit prices, but volume sales increased in emerging markets.
• The global market is stabilizing around $200–$300 million annually, with growth driven by regional socioeconomic factors.
• Competition from generics, biosimilars, and novel therapies necessitates strategic positioning—especially through combination approaches and expanding indications.
• Future growth hinges on clinical innovations, regulatory approvals of new uses, and regional market expansion, despite ongoing price pressures.
• Stakeholders should monitor evolving therapeutic paradigms to leverage opportunities effectively while mitigatin risks associated with intense competition.

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FAQs

1. How has patent expiry affected TEMODAR’s market share and revenues?
Patent expiry introduced generic competitors, sharply reducing prices and margins, leading to a decline in original brand revenues. However, increased access and volume sales in emerging markets partly offset the revenue loss.

2. What are the primary competitors to TEMODAR in the current oncology landscape?
Generic versions dominate the market; emerging therapies such as immunotherapies and targeted agents also compete, especially for glioblastoma treatment.

3. Are there any recent regulatory developments influencing TEMODAR’s market prospects?
Regulatory authorities are increasingly emphasizing evidence of improved survival and quality of life, potentially impacting indications and approval processes. Expansion into additional tumor types could open new markets.

4. What opportunities exist for future growth of TEMODAR?
Potential avenues include combination therapies, expanding indications, biomarker-driven patient selection, and entering underserved markets.

5. How do regional healthcare policies impact TEMODAR’s market dynamics?
Regions with expanding healthcare infrastructure and favorable reimbursement policies facilitate higher uptake and access, especially in Asia-Pacific and Latin America, supporting volume growth despite price constraints.

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References

[1] U.S. Food and Drug Administration (FDA). Temozolomide (Temodar) Approval Details. 1999.
[2] Market Research Future. Global Oncology Drug Market Analysis. 2022.
[3] EvaluatePharma. World Preview of Oncology Market Trends. 2023.