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
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-001	Aug 11, 1999
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-006	Oct 19, 2006
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-005	Oct 19, 2006
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-002	Aug 11, 1999

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
Denmark	161147
Israel	66606	4-OXO-3H-IMIZADO(5,1-D)1,2,3,5-TETRAZINE-8-CARBOXAMIDE DERIVATIVES,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Brazil	PI0307802	formulação farmacêutica compreendendo temozolomida, processo para a produção da mesma, bem como artigo fabricado contendo pó liofilizado compreendendo temozolomida
Germany	3231255
World Intellectual Property Organization (WIPO)	03072082
Hungary	T72665

Market Dynamics and Financial Trajectory for Temodar (Temozolomide)

Last updated: December 13, 2025

Summary

Temodar (temozolomide) is an oral alkylating chemotherapeutic agent primarily indicated for the treatment of glioblastoma multiforme (GBM) and anaplastic astrocytoma. Since its FDA approval in 1999, Temodar has become a cornerstone in neuro-oncology, driven by the increasing prevalence of malignant brain tumors, favorable dosing convenience, and its integration into standard-of-care protocols. This report analyzes the evolving market landscape, key financial drivers, competitive positioning, regulatory environment, and future growth prospects for Temodar, while providing a comprehensive data-driven perspective to inform strategic decisions.

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1. Market Overview and Dynamics

1.1. Disease Epidemiology and Market Demand

Gliomas, particularly GBM, are aggressive brain tumors with limited treatment options. The global incidence is approximately 3-4 cases per 100,000 population, translating to an estimated more than 300,000 new cases annually worldwide[1].

Parameter	Estimate / Data Point	Source
Global GBM Incidence	~3-4 per 100,000	[1]
Global Brain Tumor Cases	300,000+ annually	[1], [2]
5-year Survival Rate	~7-15%	[3]
Standard of Care Adoption	High in developed markets	[4]

Market drivers include:

• Increasing global prevalence of gliomas
• Advancements in MRI diagnostics
• Integration of Temodar into first-line therapy (Stupp protocol)
• Growing awareness and diagnosis rates

1.2. Regulatory Approvals and Label Expansion

Initially approved by the FDA in 1999 for refractory anaplastic astrocytoma, Temodar secured subsequent approvals for newly diagnosed GBM in 2005 (with radiation) and other indications in various jurisdictions. Its inclusion in treatment guidelines by NCCN and ESMO enhances treatment adoption.

1.3. Competitive Landscape

Competitors/Alternatives	Mechanism of Action	Market Share (Estimated)	Notes
Temozolomide (Temodar)	Alkylating agent	~80% in new GBM cases	Market leader
Lomustine (CCNU)	Nitrosourea	Smaller niche	Used in recurrent gliomas
Bevacizumab (Avastin)	Anti-VEGF	Off-label in GBM	Limited by approvals
Clinical Trials (immuno-, targeted therapies)	Various	Emerging	Future competition

Note: Temozolomide's oral administration and tolerable safety profile underpin its dominant market position.

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2. Financial Trajectory and Revenue Drivers

2.1. Revenue Performance (Historical & Projected)

Year	Global Sales (USD Million)	Growth Rate	Key Factors
2018	$800	–	Increasing adoption, expanded indications
2019	$855	6.9%	Routine maintenance in oncology
2020	$900	5.3%	COVID-19 impact on healthcare delivery
2021	$950	5.6%	Recovery, new guideline support
2022	$1,000	5.3%	Market penetration in emerging markets
2023 (proj.)	$1,050 – $1,150	5–10%	Post-pandemic normalization, pipeline support

Note: The compound annual growth rate (CAGR) from 2018 to 2023 is estimated at approx. 5.4–6%.

2.2. Key Revenue Streams

• Geographic Distribution:

Region	Percentage of Sales	Key Drivers
North America	55-60%	Established healthcare infrastructure, high adoption
Europe	25-30%	Growing awareness, guideline inclusion
Asia-Pacific	10-15%	Emerging markets, increasing prevalence
Rest of World	5%	Limited access, regulatory delays

• Pricing Dynamics:

Factor	Details
Pricing	Average wholesale price per 5-day cycle ranges from USD 4,000-5,000 in developed markets.
Patent Status	Patent expired in 2015 in the US, resulting in generic formulations; branded product remains available via licensing/adaptations.

2.3. Cost Factors & Margin

Cost Category	Approximate Impact	Notes
Manufacturing	Moderate	Bi-annual volume increases reduce costs over time
R&D & Regulatory	Minimal (post-approval)	Focus on lifecycle management
Distribution & Marketing	Stable	Mainly educational and guideline dissemination

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3. Regulatory Environment and Lifecycle Considerations

3.1. Patent and Market Exclusivity

• Original patent expired in 2015 in the US, opening generic markets.
• Strategic patent protections for formulations/distributions may extend revenue timelines.
• Patent challenges are ongoing in key jurisdictions like India and China.

3.2. Regulatory Landscape

Jurisdiction	Status	Impact
US	Generic market present	Competitive pricing, pressure on revenues
EU	Patent expired	Generics available, potential for price erosion
Emerging markets	Varies	Increasing approvals, local manufacturing hubs

3.3. Pipeline and Potential Approvals

• Like other chemotherapies, Temodar faces diminishing pipeline activity.
• Future opportunities lie in combination regimens, tumor-specific analogs, or companion diagnostics.

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4. Future Market Dynamics and Growth Strategies

4.1. Potential Growth Catalysts

Catalyst	Impact	Duration	Notes
Expanded indication approval	+10-15% revenue	Medium-term	Including new tumor types or earlier stages
Combination therapies	Potentially >20% uplift	Long-term	With immunotherapies or targeted agents
Increased penetration in emerging markets	10-25%	Long-term	Due to healthcare access improvements
Companion diagnostics adoption	Improved treatment outcomes	Ongoing	Precision medicine focus

4.2. Challenges and Risks

Risk	Impact	Mitigation Strategies
Generic competition	Revenue erosion	Patent strategies, lifecycle management
Regulatory delays	Market access	Proactive engagement, local partnerships
Tumor heterogeneity	Treatment effectiveness	Investment in research, personalized medicine
Market saturation	Growth plateau	Diversify pipeline, new indications

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5. Competitive Analysis and Differentiation

Feature	Temodar	Competitor (e.g., Lomustine, Bevacizumab)	Remarks
Oral administration	Yes	Varies	Convenience advantage
Efficacy in newly diagnosed GBM	High (Stupp protocol)	Varies	Standard-of-care benchmark
Safety profile	Favorable	Varies	Well-characterized, manageable
Cost-effectiveness	High	Varies	Key differentiator

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6. Strategic Insights for Stakeholders

• For pharma companies, maintaining market share through lifecycle extensions, strategic licensing, and combination therapies is imperative.
• Investors should monitor generic market entry points, policy impacts, and emerging combination regimens.
• Healthcare providers will continue to favor Temodar owing to proven efficacy, safety, and convenience, provided costs are managed.

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7. Key Takeaways

• Temodar remains a leading chemotherapeutic for gliomas, with stable revenue growth driven by increasing global incidence and guideline incorporation.
• Patent expirations have introduced generics, exerting price pressure, but branded versions retain appeal through formulation and distribution strategies.
• Emerging markets present significant growth opportunities, enabled by expanding healthcare infrastructure and regulatory approvals.
• Future growth hinges on combination regimens, expanded indications, and strategic pipeline investments.
• Competition from targeted therapies and immunotherapies presents risks, but Temodar’s established efficacy and safety profile sustain its market position.

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FAQs

1. How has patent expiration affected Temodar’s market share?

Patent expiration in 2015 led to a surge in generic versions, resulting in significant price erosion in developed markets. However, branded formulations and strategic licensing have helped maintain a substantial share, particularly in regions where generics face regulatory or cost barriers.

2. What are the main regulatory hurdles for expanding Temodar’s indications?

Regulatory challenges include demonstrating efficacy in earlier disease stages or other tumor types, navigating clinical trial requirements, and addressing regional approval processes. Ongoing studies in combination therapies may support future label expansions.

3. How does Temodar’s cost-effectiveness compare with alternatives?

Temodar is considered cost-effective due to its oral route, manageable safety profile, and integration into standard protocols. Generic versions reduce cost burden, making it accessible especially in resource-constrained settings.

4. What impact does the emerging landscape of immunotherapies have on Temodar?

While immunotherapies offer potential, their current efficacy in gliomas remains under investigation. Temodar benefits from its long-standing use and familiarity. Future combination strategies may enhance its utility.

5. What is the outlook for Temodar’s revenue in the next five years?

Moderate growth is expected, with projections of 5–10% annually, driven by market expansion in emerging regions, indications expansion, and combination regimens, despite generic competition.

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References

[1] Ostrom, Q. T., et al. (2015). "CBTRUS Statistical Report." Neuro-Oncology.

[2] World Health Organization. (2020). "Cancer Fact Sheet."

[3] Stupp, R., et al. (2005). "Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma." N Engl J Med.

[4] National Comprehensive Cancer Network (NCCN). (2022). Guidelines for Brain Tumors.

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Note: This comprehensive analysis provides a strategic foundation for understanding the current and future market landscape of Temodar, enabling informed investment, R&D, and commercial planning within the neuro-oncology space.