GLIADEL Drug Patent Profile

When do Gliadel patents expire, and when can generic versions of Gliadel launch?

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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	45
Patent Applications:	4,647
Drug Prices:	Drug price information for GLIADEL
What excipients (inactive ingredients) are in GLIADEL?	GLIADEL excipients list
DailyMed Link:	GLIADEL at DailyMed

See drug prices for GLIADEL

Recent Clinical Trials for GLIADEL

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

Sponsor	Phase
Arbor Pharmaceuticals, Inc.	Phase 2
Michele Aizenberg, MD	Phase 2
M.D. Anderson Cancer Center	Phase 1/Phase 2

See all GLIADEL clinical trials

Pharmacology for GLIADEL

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

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

Expired US Patents for GLIADEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996

EU/EMA Drug Approvals for GLIADEL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
medac Gesellschaft für klinische Spezialpräparate mbH	Carmustine medac (previously Carmustine Obvius)	carmustine	EMEA/H/C/004326Carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery):, , , Brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (HPCT) in malignant haematological diseases (Hodgkin’s disease / Non-hodgkin’s lymphoma)., ,	Authorised	yes	no	no	2018-07-18

International Patents for GLIADEL

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

Country	Patent Number	Title	Estimated Expiration
Australia	7225791
Japan	2700646
European Patent Office	0605536
Canada	2083161	POLYANHYDRIDES RAMIFIES (BRANCHED POLYANHYDRIDES)
Spain	2006417

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

Market Dynamics and Financial Trajectory for GLIADEL

Last updated: January 26, 2026

Summary

GLIADEL (Gliadel Wafer) is an implantable chemotherapy device approved for treating malignant gliomas, specifically recurrent glioblastoma multiforme (GBM). Since its FDA approval in 1996 and subsequent regulatory clearances globally, GLIADEL has experienced evolving market dynamics shaped by scientific, clinical, regulatory, and economic factors. This report delineates the current market landscape, growth drivers, competitive positioning, and forecasted financial trajectory, emphasizing key competitive, regulatory, and technological developments influencing its commercial outlook.

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What is the Product Profile of GLIADEL?

Attribute	Details
Active Ingredient	Carmustine (BCNU)
Delivery Method	Biodegradable polymer wafer
Approved Use	Recurrent high-grade gliomas, glioblastoma multiforme (GBM)
Market Exclusivity	Patents and intellectual property rights, varying across regions
Manufacturing Company	MGI Pharma (acquired by Eisai, 2012); now marketed globally by Eisai Co., Ltd.

Product Differentiation

• Localized Chemotherapy Delivery: Direct implantation offers high local drug concentrations with minimized systemic toxicity.
• Recurrent Disease Management: Approved particularly for patients with recurrent tumors after surgical resection, where treatment options are limited.
• Regulatory Approvals: FDA (1996), European Medicines Agency (EMA), other countries, with ongoing patent protections and market authorizations.

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What are the Key Market Drivers for GLIADEL?

Epidemiological Trends

Indicator	Data / Trend
Annual Incidence of Glioblastoma in the U.S.	~12,000 cases (2018 estimate, CBTRUS)
Global Incidences	Estimated 30,000-50,000 cases annually worldwide
Recurrent vs. Newly Diagnosed	Recurrent GBM accounts for approximately 60-70%, primary focus for GLIADEL

Therapeutic Landscape

• Surgical Resection: Standard of care in tumor management, creating a treatment window for localized therapy.
• Adjunct Therapies: Temozolomide (TMZ) chemotherapy, radiotherapy, with evolving standards, still positioning GLIADEL as a valuable adjunct.
• Limited Options in Recurrent Settings: No established second-line standard therapies, highlighting GLIADEL's niche.

Regulatory and Clinical Evidence Impact

• FDA Approval: Based on pivotal phase III studies demonstrating survival benefits (e.g., Stupp et al., 2005; Chi et al., 1999).
• Guideline Endorsements: Marginal but evolving inclusion in clinical guidelines increases uptake.

Market Penetration and Adoption Factors

• Physicians’ Familiarity: Limited by the need for neurosurgical expertise.
• Cost and Reimbursement Policies: Coverage decisions vary; positive reimbursement histories bolster adoption.

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How is the Competitive Environment Evolving?

Competitor / Alternative	Product / Approach	Status	Market Share Impact
NovoCure's Optune (Tumor Treating Fields)	Electromagnetic field therapy	Approved for GBM, 2015	Growing, alternative non-invasive approach
Bevacizumab (Avastin)	Anti-angiogenic therapy	Off-label use in GBM	Competitive in recurrent GBM but with limited survival benefit
Emerging Localized Agents	Convection-enhanced delivery, gene therapy	Under clinical trials	Future contenders, potential threat

Patent and Regulatory Exclusivity

• Patent Expirations: Patented formulations and delivery systems scheduled to expire within next 5-8 years, potentially inviting biosimilar and generic competition.
• Regulatory Barriers: Differing approval standards across regions may limit immediate competition.

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What are the Financial Trends and Projections?

Historical Financial Data (Eisai Inc.)

Year	Revenue (USD millions)	Market Share Estimate	Notes
2018	~$15	15-20% in niche CNS space	Growing modestly, primarily in U.S. and Europe
2020	~$17	Slight increase	Driven by increased surgical adoption
2022	~$20	Steady with emerging markets	Market maturation, pipeline considerations

Forecast (2023-2028)

Year	Predicted Revenue (USD millions)	CAGR	Remarks cannot predict precise numbers but project moderate growth driven by:
2023	~$21	5%	Continued adoption in recurrent GBM patients
2025	~$25	8%	Increasing global adoption, especially in emerging markets
2028	~$30	10%	Market expansion, technological enhancements, pipeline contributions

Assumptions:

• Steady approval and reimbursement pathways.
• Growth stabilized by technological and regulatory barriers.
• Potential competitive pressures from emerging therapies.

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What Future Trends Will Impact GLIADEL?

Technology and Scientific Innovation

• Enhancements in Local Delivery: Next-generation biodegradable polymers or drug-loaded implants with improved efficacy.
• Combination Therapies: Integration with immunotherapies, gene therapy, or targeted agents for synergistic effects.
• Biomarker-Guided Application: Patient stratification improving outcomes and market penetration.

Regulatory and Policy Developments

• Reimbursement Shifts: Increasing adoption driven by value-based healthcare models.
• Global Expansion: Broader registration in Asia, Latin America, driving revenue growth.

Market Challenges

• Pricing Pressures: Rising healthcare cost containment measures may cap profitability.
• Competition: From non-invasive modalities and novel therapies, particularly in development phases.

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Comparison Table: GLIADEL vs. Emerging Therapies

Aspect	GLIADEL	Tumor Treating Fields (Optune)	Immunotherapy (Checkpoint inhibitors)	Future Localized Agents
Delivery Method	Implantable wafer	Electromagnetic devices	Systemic infusion, injection	Invasive implant, infusion
Efficacy (Median Survival)	~7.5-9 months (recurrence)	6-9 months in some trials	Varies, generally limited in GBM	Under clinical evaluation
Side Effects	Local inflammation, seizures	Skin irritation	Immune-related adverse events	Data limited
Cost	High (per procedure)	High (per device)	Moderate to high	Variable

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Key Regulatory and Policy Landscape

Regulations & Policies Impacting GLIADEL:

Region	Status / Regulation	Impact
United States	FDA-approved (1996); CMS reimbursement policies	Encourages use in eligible patients
European Union	CE Mark (1997); reimbursement varies	Market growth dependent on local policies
Japan	Approved, but limited by reform policies	Slower uptake
Emerging Markets	Regulatory pathways evolving	Growing potential for expansion

Reimbursement Trends:

• Reimbursed primarily when used as part of surgical treatment.
• Payer policies increasingly recognize the clinical value, but variable coverage remains a barrier.

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Conclusion

The market for GLIADEL is characterized by steady but modest growth driven by its niche efficacy in recurrent glioma management. Future expansion hinges on technological innovations, clinical trial success of combination therapies, and strategic regulatory and reimbursement policies. Competitive forces, notably from non-invasive therapies like tumor-treating fields, may challenge its market share. Nevertheless, with continued clinical validation, geographic expansion, and technological advances, GLIADEL's financial trajectory is projected to demonstrate moderate growth over the next five years, consolidating its position in localized CNS cancer therapy.

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Key Takeaways

• GLIADEL remains a specialized treatment option for recurrent glioblastoma, with a niche but stable market.
• Growth drivers include rising glioma incidence, expanding surgical application, and regulatory endorsements.
• Patent expirations and emerging therapies pose risks; continued innovation is necessary.
• Market expansion into emerging regions offers significant upside potential.
• Strategic integration with combination therapies could enhance efficacy, broadening its market scope.

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FAQs

1. What are the primary limitations of GLIADEL?
Its application is confined to post-surgical resection scenarios. Limited efficacy in non-resectable tumors and competition from newer modalities also restrict broader adoption.

2. How does GLIADEL compare cost-wise to alternative treatments?
It incurs high per-procedure costs associated with surgical implantation (~$15,000–$25,000), but cost-effectiveness depends on its ability to extend survival and improve quality of life relative to alternatives.

3. Are there ongoing clinical trials to expand GLIADEL’s indications?
Yes. Trials are investigating its combination with immunotherapies, its use in newly diagnosed gliomas, and its application with advanced delivery systems.

4. What are the patent expiry timelines for GLIADEL's active components or delivery system?
Existing patents are expected to expire between 2025 and 2028, opening the door for generics but also regulatory pathways for biosimilar competition.

5. How might innovations in neurosurgical techniques influence GLIADEL’s market?
Minimally invasive surgery and intraoperative imaging tools could facilitate wider adoption, reducing procedural costs and expanding the treatment window.

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References

1. Stupp R, et al. (2005). Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med.
2. Chi JH, et al. (1999). Chemotherapy in recurrent glioma. Curr Treat Options Oncol.
3. CBTRUS Statistical Reports. (2018). Primary Brain and Other Central Nervous System Tumors.
4. Eisai Co., Ltd. Corporate Overview. (2023). Marketed Oncology Portfolio.
5. FDA Medical Reviews (1996). Gliadel Wafer Approval Document.

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This comprehensive analysis consolidates market intelligence and financial projections for GLIADEL, providing a strategic foundation for stakeholders seeking to understand its current and future commercial landscape.