GLIADEL Drug Patent Profile

When do Gliadel patents expire, and what generic alternatives are available?

Gliadel is a drug marketed by Azurity and is included in one NDA.

The generic ingredient in GLIADEL is carmustine. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the carmustine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gliadel

A generic version of GLIADEL was approved as carmustine by NAVINTA LLC on September 11^th, 2018.

Summary for GLIADEL

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for GLIADEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996		RX	Yes	Yes

International Patents for GLIADEL

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0532638
Spain	2006417
European Patent Office	0511292	POLYANHYDRIDES D'ACIDES ALIPHATIQUES OLIGOMERISES INSATURES (POLYANHYDRIDES OF THE OLIGOMERIZED UNSATURATED ALIPHATIC ACIDS)
Japan	H05503286

Supplementary Protection Certificates for GLIADEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0260415	C990036	Netherlands		PRODUCT NAME: CARMUSTINE; NAT. REGISTRATION NO/DATE: RVG 24056 19990809; FIRST REGISTRATION: FR 561 907-5 19981210
0260415	SPC/GB01/013	United Kingdom		PRODUCT NAME: N,N'-BIS(2-CHLOROETHYL)-N-NITROSO-UREA (CARMUSTINE) COMBINED WITH A POLYANHYDRIDE HAVING A WEIGHT AVERAGE MOLECULAR WEIGHT OF GREATER THAN 20,000 PREPARED BY THE POLYCONDENSATION OF: (I) 4,4'-(TRIMETHYLENEDIOXY)-DIBENZOIC ACID; AND (II) SEBACIC ACID (POLI; REGISTERED: FR 561 907-5 19990105; UK PL 00012/0337 20000928

Last updated: February 10, 2026

mmary:
GLIADEL (carmustine implant) is a biodegradable, wafer-shaped drug approved for maintaining tumor control in patients with newly diagnosed malignant glioma after surgery and radiation. It holds a niche market focused on brain cancer, primarily glioblastoma multiforme (GBM). The product’s sales are limited due to specific indications, high treatment costs, and competitive landscape involving emerging therapies. Analyzing its investment and fundamentals requires assessing market size, regulatory environment, competitive options, ongoing development, and financial performance.

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What Is the Market Outlook for GLIADEL?

GLIADEL was approved by the FDA in 2003 and by EMA in 2004. It is deployed as an adjunct during surgical resection. Market revenue peaked in the late 2000s but has since plateaued due to limited indications and competition.

Market Size and Penetration

• Global glioblastoma incidents: Estimated 12,000-13,000 cases annually in the U.S. and Europe combined ([1]).
• Eligible patients: A subset undergoes surgical resection with intracavitary treatment.
• Estimated annual sales: Historically peaked at approximately $50-60 million; current estimates suggest $30-40 million, reflecting market stagnation or slight decline due to competition ([2]).

Growth Drivers

• Increased awareness of surgical adjuncts.
• Potential expansion in emerging markets.
• Technological improvements reducing procedural costs.

Constraints

• Narrow indication confined to use with surgery and radiation.
• Limited adoption driven by high cost (~$10,000 per wafer) and surgical requirements.
• Competition from systemic therapies, including chemotherapies and targeted agents progressing into front-line treatment.

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What Are the Regulatory and Clinical Fundamentals?

Regulatory Status

• FDA approval: 2003 for recurrent gliomas and newly diagnosed GBM.
• EU approval: 2004; approved for same indications.
• Off-label use: Rare, with some neuro-oncologists exploring adjuncts.

Clinical Data & Efficacy

• Key studies: Randomized trials (e.g., Stupp et al., 2005) show that resected GBM responds better to combined modalities.
• GLIADEL’s evidence base:
  • Improves progression-free survival (PFS).
  • No significant overall survival (OS) benefit demonstrated alone.
  • Adverse events include cerebral edema and wound healing issues.

Guideline Recommendations

• Accepted as an adjunct but not universally adopted.
• Usage varies by center; best suited for patients with complete resection.

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What Are the Competitive Dynamics and Innovation Trends?

Competitors

• Systemic chemotherapies: Temozolomide remains standard, replacing older agents.
• Emerging interventions: Tumor-treating fields (Optune), immunotherapy (e.g., PD-1 inhibitors), and gene therapy.

Pipeline and Innovation

• Several experimental localized therapies (e.g., convection-enhanced delivery of drugs) aiming to surpass GLIADEL.
• Notably, no recent approvals of wafer-type implants show competitive pressure, but systemic therapies improve outcomes overall.

Intellectual Property and Patent Life

• The original patent expired around 2014.
• Manufacturing processes remain protected as trade secrets, limiting generic competition.
• No recent patent filings specifically protecting GLIADEL’s formulation.

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What Is the Financial Health and Investment Performance?

• Revenue trends: Peaked early, now flat or declining.
• Profitability: Limited; high manufacturing and distribution costs impact margins.
• R&D spending: Focused on related drug delivery systems and new indications; initial R&D costs amortized.
• Partnerships: Majority owned by Novocure, which markets it through its own sales force.

Valuation Considerations

• Given stable but modest revenues, key valuation drivers include growth in emerging markets, clinical pipeline success, and adoption rate improvements.
• Stock impact depends heavily on new data or indication expansion; currently, the outlook is cautious due to market saturation.

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Key Takeaways

• GLIADEL addresses a niche market for glioblastoma adjunct therapy.
• Sales peaked over a decade ago, with little recent growth.
• Clinical benefits are limited to delaying progression, with no proven survival advantage.
• Competition from systemic therapies and emerging localized treatments pose long-term risks.
• Future value depends on pipeline success, market expansion, and regulatory developments.

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FAQs

Q1: What are the main regulatory challenges facing GLIADEL?
Regulatory challenges include demonstrating clear survival benefits beyond progression delay and expanding indications. Approval for new uses is uncertain due to the high success bar.

Q2: How does the market size impact investment potential?
The limited patient population (~13,000 cases annually) constrains revenue growth. Market penetration depends on surgeon adoption and cost considerations.

Q3: Are there any recent clinical trials that could expand GLIADEL’s use?
No significant recent trials have demonstrated new indications or substantial survival benefits, keeping its use within its current niche.

Q4: How does the competition from systemic therapies affect GLIADEL?
Systemic therapies like temozolomide have become standard, reducing reliance on local wafers. Emerging therapies may further diminish its market share.

Q5: What are the key factors influencing GLIADEL’s future valuation?
Success of pipeline developments, market expansion, regulatory approvals for new indications, and competitive landscape shifts are critical.

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Citations
[1] Stupp R, et al. "Radiotherapy plus Concomitant and Adjuvant Temozolomide for Glioblastoma." New England Journal of Medicine. 2005.
[2] MarketWatch, "Glioblastoma Multiforme Market Analysis," 2022.