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. Twelve 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:	1,110
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	POWDER;INTRAVENOUS	022277-001	Feb 27, 2009

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
Austria	380256
Austria	A319182
Australia	571430
Australia	5838494
Australia	6371198
Australia	8749382

Temodar (temozolomide) market dynamics and financial trajectory: exclusivity, generic risk, and revenue outlook

Last updated: July 26, 2026

Executive summary: Temodar (temozolomide) is a legacy, oncology small-molecule with a patent and exclusivity stack that has largely matured into a post-peak, generic-driven market. Revenue is now shaped by (1) geographic generic penetration, (2) oncology demand cycles tied to glioblastoma and other temozolomide-used indications, (3) payer and hospital contracting behavior for generics, and (4) lifecycle events tied to combination regimens (notably radiation plus temozolomide) that sustain utilization even as branded economics erode.

What is Temodar (temozolomide) and where does it generate sales in oncology?

Temozolomide is an oral alkylating agent used most prominently in neuro-oncology, with clinical adoption concentrated in:

• Glioblastoma (GBM)
  • Newly diagnosed GBM: standard-of-care includes radiotherapy plus temozolomide, followed by adjuvant temozolomide (the “Stupp regimen”).
• Recurrent or progressive GBM
  • Used as salvage therapy in common real-world practice pathways.
• Other brain tumors
  • Temozolomide is also used off-label and in some labeled contexts depending on region and product history, but GBM is the commercial anchor.

Commercial implication: even after branded exclusivity sunsets, the regimen-based, protocol-driven use pattern sustains total market demand. Branded Temodar revenue typically declines first from pricing pressure, then from channel substitution to lower-cost generics.

How does the administration format affect market uptake?

Temozolomide is oral, which affects hospital prescribing workflows and payer formularies differently than infusible oncology agents. Supply continuity and dose availability (capsule/strength formats historically) are key determinants of substitution dynamics when generics enter.

How has Temodar’s financial trajectory evolved from launch through post-patent decline?

Executive summary of trajectory pattern: Temodar follows a classic branded oncology profile: peak under differentiated clinical positioning, then contraction as generics enter and as discounted contracting shifts purchasing toward the lowest-cost approved alternatives.

Key phases:

1. Brand build and guideline adoption
   • Adoption accelerates when temozolomide is integrated into GBM standards of care.
2. Peak sales under branded pricing
   • Manufacturer revenue benefits from limited competition while payer and provider protocols remain brand-loyal.
3. Generic erosion
   • As temozolomide generics launch, branded sales fall sharply due to automatic substitution pressure, contracting, and step therapy.
4. Stabilization at “total class demand” level
   • Brand declines to residual premium segments (patients with tolerability preferences, specific packaging access, or prescriber habits), while overall utilization remains supported by GBM incidence and regimen standards.

Commercial implication for forecasting: long-run revenues trend toward a stable “class market” demand level, but branded revenues trend toward minimal shares after robust generic penetration in major markets.

When does Temodar lose exclusivity, and what does that mean for generic entry risk?

Temodar’s exclusivity has been substantially time-limited by patent terms and regulatory exclusivity structures across jurisdictions. For business planning, the market-impact mechanism is the same even if specific patent dates vary by country:

• Post-expiration: generics can obtain approval pathways that allow market entry without branded pricing power.
• Paragraph IV / litigation dynamics (US): where branded patent estates are challenged, settlements can delay or accelerate entry.

Net effect: generic entry risk is less about whether temozolomide demand disappears and more about how quickly branded share collapses once equivalent product supply expands.

What generic launch scenarios affect price and volume?

• Scenario A: quick, multi-supplier generic entry
  • Price floors fall faster, and branded sales compress early.
• Scenario B: slower entry with fewer competitors
  • Brand can retain higher pricing for longer due to reduced substitution speed.
• Scenario C: payer-led interchangeability
  • Even before full erosion of the branded channel, payers can drive prescriptions to the lowest-cost generic through formulary placement and rebates.

What patents protect Temodar and how strong is the patent estate around temozolomide?

Temodar’s IP estate is structured around temozolomide itself and related lifecycle claims (formulations, dosing forms, and method-of-use combinations). From a market standpoint, this matters because:

• Method-of-use patents can limit “label-to-practice” exclusivity but generally do not stop generic manufacturing and labeling for core drug identity once basic compound protection ends.
• Formulation and process patents can delay specific generic products if they claim particular release, stability, or manufacturing steps.

Business relevance: investors and licensees typically model a two-stage erosion: (1) compound/patent expiry enabling generics, then (2) additional litigation reducing the “design-around” space for later, differentiated generic products.

How many patent types typically matter for market exclusivity?

• Compound (active ingredient)
• Formulation (dosage form, capsule composition, or excipient systems)
• Method-of-use (GBM protocol, dosing schedule)
• Manufacturing/process patents
• Regulatory exclusivity constructs (jurisdiction-specific)

What is the Orange Book status of Temodar and what does it imply for FDA-approved generics?

In the US, the Orange Book is the key tool for mapping branded listings to generic eligibility. For an investor or litigation strategist, the Orange Book implications are:

• If core listings have expired: FDA-approved generics can generally enter with fewer legal barriers.
• If method-of-use patents remain listed and relevant: generic label design may still differ, though substitution for standard regimens often remains feasible through off-label use or label carve-outs depending on the patent.

Net effect on market dynamics: once most blocking patents expire, the remaining Orange Book listings tend to influence labeling details rather than total class sales volume.

How do payer contracting and formulary dynamics shape Temodar pricing after generic entry?

After generic entry, payer behavior determines how quickly “brand economics” collapse:

• Average selling price compression typically occurs when multiple generics gain competitive rebate floors.
• Hospital purchasing and group purchasing organization contracts drive fast substitution in oncology settings.
• Patient out-of-pocket considerations influence retail or speciality pharmacy channels.

Commercial implication: Temodar’s branded revenue can fall faster than total class volume because it is priced at a premium that contracting pressures eliminate.

What competitor landscape exists for temozolomide after brand erosion?

Executive summary: The temozolomide class shifts to a generic-dominated market with multiple approved manufacturers supplying different strengths and packaging configurations.

The competitive set typically includes:

• US and ex-US generic manufacturers
• Authorized distributors and secondary market participants
• Specialty oncology wholesalers

Market dynamics drivers:

• Competitive pricing
• Contract awards
• Supply reliability
• Product stability and shelf-life management

What does Temodar demand look like in GBM and how does incidence drive the total market?

Temozolomide demand is tied to:

• GBM incidence and treatment prevalence
• adherence to the radiation plus temozolomide protocol in newly diagnosed GBM
• usage patterns in recurrent GBM

Financial impact: even when price declines with generics, the “base demand” from standard-of-care practice can keep the total market from collapsing.

Which regulatory pathways and safety/quality standards shape generic substitution?

For generics in temozolomide:

• Bioequivalence and CMC compliance determine approval timing.
• Quality systems and manufacturing validation reduce risk of supply disruptions.
• Stability of oral dosage packaging affects pharmacy stocking and continuity.

Business implication: supply interruptions can transiently improve branded share or prices for remaining branded product inventory, but steady-state dynamics favor lower-cost generics.

How do biosimilar-like dynamics apply to Temodar’s small molecule market?

Temozolomide is not a biologic; biosimilar frameworks do not apply. The analog to “biosimilar risk” in this category is:

• Generic substitution risk
• Labeling and patent carve-out risk
• Supply competition

Net effect: once generics are fully cleared and contracting switches, brand differentiation is mostly reduced to non-patent factors like channel preference and inventory logistics.

What litigation and settlements historically affect temozolomide market entry timing?

In small-molecule branded oncology, US entry timing often reflects:

• Paragraph IV filings against Orange Book-listed patents
• district court outcomes
• Hatch-Waxman settlement agreements (where applicable)

Market impact mechanism: settlements delay generic entry for a period. Once delay ends, volume capture by generics is typically rapid if multiple filers are cleared.

How does Temodar compare with other GBM regimens on commercial resilience?

Commercial resilience depends on:

• Protocol integration strength
• Off-label flexibility
• Requirement for specific administration schedule
• Competition intensity from other oncology agents

Temozolomide’s resilience comes from its entrenched protocol role in GBM care pathways. Other drugs with less protocol centrality generally face larger demand volatility when payer policies change.

What are the key financial KPIs used to track Temodar’s trajectory?

For modeling brand and class performance, the most decision-relevant KPIs are:

• Net sales by geography (US vs ex-US, where generic launch timing diverges)
• Share vs class (brand share typically declines; class volume may remain stable)
• Price/mix and ASP changes
• Inventory and supply disruptions (particularly around contracted inventory)
• Gross margin compression after contracting shifts
• Channel mix (hospital vs retail/specialty)
• GLP-1 of oncology demand proxies: GBM treatment incidence, regimen adherence, and payer coverage trends

Temodar revenue outlook: what drives upside or downside after generic penetration?

Downside drivers

• Faster-than-expected generic substitution due to aggressive contracting
• Additional competitors entering and pushing price floors lower
• Supply instability that shifts demand away from specific SKUs (though this can cut both ways)
• Payer restrictions on off-protocol use in recurrent contexts

Upside drivers

• Sustained adherence to GBM standard regimens supporting class volume
• Product-level packaging improvements that reduce disruption risk
• Longer tail of brand purchasing in select contracts due to pharmacy availability or tender terms

Key Takeaways

• Temodar’s market dynamics are dominated by generic substitution and payer contracting, not by biological competition.
• Total temozolomide class demand remains anchored by GBM protocol integration, which supports market continuity even as branded revenue erodes.
• Financial trajectory follows a branded peak-to-generic decline pattern, with residual brand exposure determined by contract specifics and supply dynamics.
• The practical “exclusivity question” is whether remaining Orange Book listings and jurisdiction-specific patent estates meaningfully delay generic label-to-practice substitution; once they do not, branded economics compress quickly.

FAQs

1. How quickly do Temodar branded sales typically drop after generic temozolomide launches in the US?
2. Do method-of-use patents meaningfully protect Temodar from generic substitution in GBM treatment?
3. What formularies and contracting levers most influence temozolomide pricing after patent expiry?
4. How do supply constraints of temozolomide capsules affect short-term branded versus generic sales mix?
5. Which GBM patient segments drive the remaining non-linear demand swings for temozolomide?

References (APA)

1. FDA. “Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).” US Food and Drug Administration.
2. Stupp R, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. New England Journal of Medicine (landmark publication supporting standard-of-care use pattern).