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. Nine 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

Expired US Patents for TEMODAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	8,623,868
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-004	Aug 11, 1999	5,260,291*PED
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009	7,786,118
Merck Sharp Dohme	TEMODAR	temozolomide	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009	6,987,108

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

International Patents for TEMODAR

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

Country	Patent Number	Title	Estimated Expiration
China	100346784
Belgium	894175
African Intellectual Property Organization (OAPI)	7174
Italy	8222938
Austria	397440

Market Dynamics and Financial Trajectory for TEMODAR (temozolomide)

Last updated: February 19, 2026

What is Tempozolomide’s Market Position?

TEMODAR (temozolomide) is an oral alkylating agent approved for the treatment of gliomas, specifically glioblastoma multiforme (GBM), and other malignant gliomas. It is a first-line chemotherapeutic agent under several regulatory approvals globally, notably by the U.S. Food and Drug Administration (FDA) in 1999.

Its market influence is primarily within neuro-oncology, competing with drugs like lomustine and carmustine. It is also leveraged in combination therapies, expanding its use into broader oncological treatment protocols.

How Has the Market Evolved Since Launch?

Market introduction in 1999 coincided with the approval of the Stupp protocol in 2005, which combined radiotherapy with temozolomide. This significantly increased demand. Global sales peaked in the late 2010s, driven by increased diagnoses of gliomas due to advances in neuro-oncology diagnostics.

Sales Data and Market Valuation

Year	Global Sales (USD million)	CAGR (2018–2022)
2018	350	N/A
2019	400	12.9%
2020	440	10%
2021	480	9.1%
2022	510	6.3%

Market analysis by IQVIA indicates a gradual growth trajectory, driven by increasing glioma incidence and off-label uses.

Patent and Regulation Impact

The expiration of key patents in 2018 in the U.S. has opened markets to generic competitors, reducing prices and impacting manufacturer revenue. Regulatory approvals in emerging markets increase potential volume, while ongoing research investigates new formulations and combination therapies to sustain sales.

What Are the Key Market Drivers?

• Incidence of Gliomas: Rising global glioma diagnoses, with an estimated 3.4 per 100,000 people annually in developed countries.
• Treatment Protocols: Adoption of temozolomide in standard-of-care protocols for newly diagnosed GBM.
• Regulatory Approvals: Extended approvals for recurrent gliomas and other cancers in markets like Asia and Europe.
• Combination Therapies: Increased use of temozolomide with radiotherapy and immunotherapies.

What Factors May Limit Market Growth?

• Patent Expiry and Generic Competition: Key patents expired in 2018, leading to price compression and market share dilution.
• Side Effect Profile: Common adverse effects, including myelosuppression and nausea, influence treatment adherence.
• Alternative Treatments: Emergence of targeted therapies and immunotherapies under clinical development could challenge temozolomide’s dominance.

What Is the Future Financial Trajectory?

Estimations project a stabilization or slight decline in sales due to generic competition, with a compounded annual growth rate (CAGR) of roughly 2-3% over the next five years. Market expansion into Asia and Latin America could offset some declines, driven by increased healthcare access.

Forecasted Market Size (2023–2027):

Year	Projected Sales (USD million)	Growth Rate %
2023	520	1.9%
2024	530	2.0%
2025	540	1.9%
2026	550	1.8%
2027	560	1.8%

What Are the Key Opportunities?

• New Formulations: Development of formulations with improved bioavailability and reduced side effects.
• New Indications: Clinical trials exploring efficacy in other cancers, such as melanoma and metastases.
• Biomarker Development: Patient stratification to optimize responders, increasing treatment efficacy and market penetration.

What Are the Main Risks?

• Patent Challenges: Patent litigations and patent cliff effects could accelerate generic entry.
• Regulatory Barriers: Delays or denials in approvals for new indications in key markets.
• Market Competition: Incorporation of advanced therapies reducing reliance on chemotherapeutics like temozolomide.

Key Takeaways

• TEMODAR remains a core neuro-oncological drug with steady but slowing growth.
• Patent expirations have contributed to pricing pressure and market share erosion.
• Expansion into emerging economies offers growth potential.
• Competition from targeted therapies and immuno-oncology agents poses strategic risks.
• Innovation in formulations and new indications will be vital to sustain revenues.

FAQs

1. How does the patent expiration affect TEMODAR’s market?
It facilitates generic production, reducing prices and eroding revenue for original manufacturers.

2. What are the primary markets for TEMODAR?
North America, Europe, and Asia-Pacific represent the largest markets.

3. Are there ongoing clinical trials for TEMODAR?
Yes, trials are testing combination therapies and new indications in lung, melanoma, and other cancers.

4. What is the typical treatment regimen with TEMODAR?
Conventional courses involve 5 days of oral doses in 28-day cycles, combined with radiotherapy in initial treatment phases.

5. How do side effects impact market dynamics?
Adverse effects can limit patient adherence but are often manageable, preventing significant market restriction.

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References

[1] IQVIA. (2022). Global Oncology Market Reports.
[2] U.S. FDA. (1999). FDA Approval for Temozolomide.
[3] Stupp, R., et al. (2005). 'Radiotherapy plus Concomitant and Adjuvant Temozolomide for Glioblastoma.' The New England Journal of Medicine.
[4] GLOBOCAN. (2020). Global Cancer Statistics.
[5] Pharmaceutical Market Reports. (2023). Oncology Drugs Market Analysis.