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	4,757,128
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996	4,789,724
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996	5,179,189

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
Japan	2700646
Greece	880300163
Australia	667325
Greece	3022577
Japan	S63199227	PRODUCTION OF ANHYDROUS POLYMER
Spain	2093647

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: July 28, 2025

Introduction

Gliadel, marketed as Gliadel, is a unique chemotherapeutic implant designed for the treatment of malignant gliomas, particularly recurrent glioblastoma multiforme (GBM). Initially approved by the U.S. Food and Drug Administration (FDA) in 1996, Gliadel represents a niche but critical intervention in neuro-oncology. Its market trajectory and financial performance are shaped by complex clinical, regulatory, and competitive factors. This analysis delineates the current market dynamics, future growth prospects, and key financial parameters influencing Gliadel’s trajectory.

Market Landscape and Clinical Positioning

Unmet Medical Needs

Gliadel addresses a significant unmet need within neuro-oncology: localized delivery of chemotherapy to brain tumors. Recurrent GBM remains highly lethal, with median survival approximately 14-16 months despite aggressive treatment. The drug's capacity for delivering carmustine directly into resection cavities offers a therapeutic advantage in targeting residual tumor cells while minimizing systemic toxicity (1).

Regulatory Approvals and Indications

Initially approved for malignant glioma after resection, Gliadel’s indications have expanded slightly but remain confined primarily to recurrent tumors. Regulatory agencies, including the FDA and European authorities, recognize its niche role, which influences market penetration and reimbursement strategies.

Clinical Evidence and Adoption Trends

Numerous studies underscore Gliadel’s benefits in prolonging progression-free survival, but limitations in overall survival gains, logistical administration challenges, and the need for combined therapies constrain broader adoption (2). The clinical community often views Gliadel as an adjunct rather than a standalone solution, impacting sales volume.

Competitive Landscape

The neuro-oncology market is increasingly populated with systemic therapies, including temozolomide and emerging immunotherapies. Although few direct competitors replicate Gliadel’s local delivery mechanism, systemic agents with superior efficacy or novel modalities such as tumor-treating fields (TTF) impact its market share:

• Systemic Chemotherapy: Temozolomide remains the backbone of initial GBM treatment but is not directly comparable in recurrent settings.
• Emerging Modalities: Tumor-treating fields and targeted therapies, like bevacizumab, influence treatment algorithms, potentially reducing reliance on Gliadel (3).

Market Dynamics Influencing Growth

Regulatory and Patent Status

Gliadel’s patent landscape is mature, with patent expirations affecting price and market exclusivity. The expiration in key markets generally leads to increased off-label use but also triggers price-based competition, especially from generic equivalents or biosimilars once biosimilar pathways are established.

Pricing and Reimbursement Environment

Reimbursement varies geographically and significantly influences market access. High procedure costs, coupled with limited reimbursements in certain regions, can restrict adoption among neurosurgeons and hospitals. Managed care organizations tend to favor less invasive systemic options, which may further constrain market expansion.

Technological Advancements and Delivery Innovations

Innovations in drug delivery technologies, such as biodegradable implants and nanocarriers, threaten to replace Gliadel’s current delivery system. Conversely, ongoing research into combination therapies pairing Gliadel with systemic agents could enhance its efficacy and market appeal.

Market Penetration and Geographic Expansion

While North America and Europe comprise the primary markets, growing interest in neuro-oncology in Asia-Pacific presents opportunities. However, regulatory hurdles, cost considerations, and differing clinical practices impact penetration rates.

Financial Trajectory and Projections

Historical Revenue Performance

Gliadel’s revenues have plateaued or declined modestly over recent years due to patent expiration effects, increasing competition, and limited indication expansion. In 2021, estimated global sales approximated $50 million, predominantly driven by North American markets (4). The drug’s niche positioning results in relatively stable revenues but limited growth potential absent significant market expansion.

Future Revenue Drivers

Key drivers for future revenue include:

• Geographic Market Expansion: Regulatory approvals in emerging markets could lead to incremental growth.
• Clinical Adoption: Demonstration of improved outcomes via combination therapies may expand use cases.
• Reimbursement Policies: Favorable coverage decisions enhance market access.
• Pipeline and Formulation Innovations: Development of novel formulations could extend patent life or improve administration convenience.

Impact of Patent and Competition

Post-patent expiration, revenue decline is expected unless new formulations or indications are secured. The advent of biosimilars or alternative local delivery systems could further compress profit margins.

Financial Outlook

Given current market dynamics, Gliadel’s revenue projections indicate a modest decline over the next five years unless significant expansion strategies are employed. Strategic collaborations, clinical trial successes, or regulatory milestones could reverse this trend, offering upside potential.

Strategic Considerations and Opportunities

• Innovation in Delivery Technology: Investing in next-generation implants that integrate with systemic therapies.
• Combination Regimens: Clinical trials exploring synergy with immunotherapies or targeted agents.
• Geographic Expansion: Navigating regulatory pathways in emerging markets.
• Reimbursement Negotiations: Engaging payers early to secure favorable coverage.

Key Challenges

• Limited indication breadth constrains growth.
• Competition from systemic therapies and novel modalities.
• Patent expiration diminishes exclusivity.
• High procedural costs hinder adoption in cost-sensitive regions.

Conclusion

Gliadel remains a specialized but vital option within neuro-oncology. Its market dynamics are characterized by a niche position amidst evolving therapeutic landscapes, with revenues impacted by competition, patent expirations, and clinical adoption patterns. Strategic innovation, clear demonstration of clinical benefit, and expansion into new markets are essential to sustain and enhance its financial trajectory.

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Key Takeaways

• Niche Market Position: Gliadel effectively targets residual GBM post-surgery but faces limitations from systemic therapy alternatives.
• Revenue Stability with Limited Growth: Current revenues are stable but show limited growth potential without expansion strategies.
• Patent and Competition Risks: Patent expiration and emerging competitors threaten profitability unless complemented by innovation or new indications.
• Opportunities in Global Markets: Expansion into Asia-Pacific and other emerging regions offers potential upside.
• Strategic Alignment Needed: Collaborations on combination therapy trials and delivery technology innovation remain critical to prolonging Gliadel’s market relevance.

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FAQs

1. What is Gliadel’s primary mechanism of action?
   Gliadel delivers carmustine (BCNU) directly into the surgical cavity, enabling localized chemotherapy to target residual tumor cells while minimizing systemic toxicity.

2. How has patent expiration affected Gliadel’s market share?
   Patent expirations have led to increased availability of generic alternatives and biosimilars, exerting downward pressure on prices and market share.

3. What are the main competitors to Gliadel in neuro-oncology?
   Systemic therapies such as temozolomide, bevacizumab, and emerging modalities like tumor-treating fields compete indirectly by offering alternative treatment options.

4. Can Gliadel be used in newly diagnosed GBM cases?
   Currently, Gliadel’s primary approval is for recurrent malignant gliomas post-resection. Use in newly diagnosed cases is limited and typically off-label.

5. What prospects exist for Gliadel’s future growth?
   Growth hinges on expanding indications, geographic reach, and demonstrating enhanced outcomes via combination therapies, alongside innovation in delivery systems.

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References

1. [1] FDA Approval Announcement, 1996.
2. [2] Stupp R, et al. “Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma.” N Engl J Med. 2005.
3. [3] Weller M, et al. “Recurrent glioblastoma: management challenges and evolving therapy options.” Nat Rev Clin Oncol. 2020.
4. [4] Market Reports, SciBeth. “Gliadel Market Analysis, 2022.”