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:	4,679
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
Michele Aizenberg, MD	Phase 2
Arbor Pharmaceuticals, Inc.	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	5,179,189
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996	4,789,724

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
Austria	141804
Austria	145657
Canada	1274339	SYNTHESE ET APPLICATION DE POLYANHYDRIDES A POIDS MOLECULAIRE ELEVE (SYNTHESIS AND APPLICATION OF HIGH MOLECULAR WEIGHT POLYANHYDRIDES)

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

GLIADEL (carmustine implant) Market Dynamics and Financial Trajectory: Sales Trends, Pricing Pressure, Patent/Exclusivity Timing, and Competitive Threats

Last updated: July 28, 2026

GLIADEL (carmustine implant; AstraZeneca legacy) is a neurosurgical oncology product with a concentrated institutional customer base and demand tied to glioblastoma treatment pathways. Post-launch growth has largely stabilized into a mature, procedure-linked revenue stream, with ongoing pressure from competing intracranial delivery modalities, resection-adjuvant practice variability, and payer controls. Revenue trajectory is driven less by broad outpatient prescribing and more by the number of eligible craniotomy procedures and hospital adoption.

What is the GLIADEL sales trajectory since launch and what drives annual revenue swings?

GLIADEL is used as an implant placed during surgery for malignant gliomas. Revenue moves with:

1. Craniotomy volume and glioblastoma incidence treated surgically
2. Institutional adoption and neurosurgeon practice patterns
3. Payer coverage and site-of-care procurement mechanics
4. Pricing and contract renegotiations in hospital formularies

Market structure: hospital procurement over retail demand

GLIADEL’s demand is routed through hospital pharmacies, neurosurgical centers, and group purchasing organizations. This creates:

• Lower retail-type volatility but recurring annual changes in contract pricing and formulary status
• A slower ramp than oncology drugs with broad prescriber reach

How does GLIADEL compare with other local/regional GBM adjuvant approaches?

GLIADEL is an intracranial local therapy that competes for “adjuvant space” against:

• Systemic chemotherapy regimens (e.g., temozolomide-centered standard of care)
• Device- and technique-based approaches to local drug delivery (implantable polymers, convection-enhanced delivery workflows)
• Clinical shifts that emphasize systemic therapy and multimodal regimens

What market dynamics are most important for GLIADEL: payer coverage, institutional buying, and adoption?

Payer and coverage dynamics

The product’s economics depend on payer policies for:

• Medical benefit classification (often under specialty pharmacy or medical benefit depending on billing structure)
• Prior authorization patterns for high-cost oncology supplies
• Medical necessity documentation at the time of surgery

Institutional adoption dynamics

GLIADEL adoption is influenced by:

• Neurosurgical comfort with implantation workflow
• Operating room and pharmacy logistics
• Quality metrics and institutional outcomes reporting

Pricing pressure and contracting

Hospitals shift procurement based on:

• Competitive bids from implant and local-delivery alternatives
• Annual GPO price resets
• Bundled reimbursement pressure for surgical oncology care

When does GLIADEL lose exclusivity and what does that imply for financial outlook?

Patent and exclusivity timeline: the practical framing

GLIADEL’s risk profile for generic entry and biosimilar-like substitution (not applicable in the same sense as biologics) is shaped by:

• Carmustine implant device/formulation IP
• Method-of-use and local delivery claims
• Regulatory data exclusivity, if any, from the original marketing authorization

A detailed exclusivity and patent expiration map requires the specific Orange Book listing(s) for each GLIADEL dosage strength and the current regulatory holder in the US. Without that listing set, a precise date-based exclusivity conclusion cannot be produced.

What does exclusivity loss typically change for a mature implant product?

When core implantation and formulation IP protection erodes, financial outcomes usually reflect:

• Faster price erosion in contracted hospital settings
• Revenue share shift to lower acquisition cost suppliers
• Margin compression for the brand holder and channel partners

What is the Orange Book status of GLIADEL and how many listed patents cover it?

Orange Book status and the count of listed patents per strength and dosage form are determined by the active US NDA/approval record and its listed patent families (drug substance, drug product, and method-of-use). Producing a complete “how many patents” count with specific numbers and expiration dates requires the authoritative current Orange Book record, including listing identifiers.

Without the listing content, a complete and accurate patent coverage assessment cannot be generated.

Which competitors threaten GLIADEL in glioblastoma local therapy and how do they impact pricing?

Competitive substitution patterns

Local therapy products face substitution constraints:

• Surgical technique differences
• Implant handling, sterility, operating time, and neurosurgical training
• Institutional preference and prior experience

Revenue implication of competitive pressure

In mature hospital-only oncology products, competition affects:

• Unit volume at the institution level
• Net price through tendering and GPO renegotiations
• Formulary placement for eligible procedures

Where systemic therapy dominates survival endpoints, local adjuncts can face variability in adoption even without direct regulatory substitution. That variability can cause multi-year revenue drift rather than a single step-change event.

What patent litigation or Paragraph IV challenges affect GLIADEL’s commercial trajectory?

Paragraph IV challenges are specific to ANDA generics for small molecules and are tied to Orange Book-listed patents. GLIADEL is an implanted carmustine product. Whether ANDA-type litigation exists depends on:

• Current Orange Book listings
• Whether generic applicants have submitted ANDAs (or other equivalent pathways)

A litigation timeline with case captions and court outcomes requires the specific docketed cases tied to GLIADEL’s Orange Book patents. That set of records is not provided here, so no complete litigation chronology can be stated accurately.

What generic entry risks exist for GLIADEL and how soon could a low-cost product reach hospitals?

Generic entry risk for an implant depends on:

• Formulation IP and device-related claims
• Bioequivalence and release characteristics for intracranial delivery
• Manufacturing and sterile implant process reproducibility
• Regulatory acceptance of comparable implant release kinetics

For a complete “soonest plausible entry” market-risk scenario, the controlling patent expiration and any stays from litigation or settlement agreements are required. Those details rely on the current Orange Book listing and litigation status.

What FDA regulatory and manufacturing constraints shape GLIADEL availability and cost?

GLIADEL’s availability constraints are typical of implantable sterile oncology products:

• Sterile manufacturing controls and batch release testing
• Chain-of-custody logistics to OR delivery windows
• Distribution through specialty hospital channels

These factors can cause:

• Periodic supply disruptions with revenue impacts
• Higher working capital tied to limited production runs
• Cost headwinds that change annual net sales even when unit volume is stable

How do commercial metrics map to financial performance for GLIADEL (units, net price, and channel mix)?

For hospital concentrated products, financial performance typically follows:

• Unit volumes: procedures where the implant is used
• Net price: contract pricing vs list price
• Mix: geography and IDNs (integrated delivery networks)
• Rebate/discounts: hospital and wholesaler contracts

A robust revenue bridge typically attributes changes to:

1. Procedure eligibility and adoption
2. Net pricing and contract resets
3. Supply stability and order fulfillment

A quantified revenue bridge (by year) cannot be produced without disclosed financial statements or standardized sales datasets for GLIADEL.

What is the financial trajectory likely to look like over the next 3–5 years under mature-drug dynamics?

Given GLIADEL’s mature category profile:

• The base case is stable-to-slow decline driven by practice pattern variability and gradual pricing pressure
• Upside is limited unless:
  • A measurable guideline or clinical pathway increases local implant adoption
  • A supply or manufacturing constraint eases and supports full demand
• Downside accelerates if:
  • Core IP barriers break and low-cost competing implants capture hospital tenders
  • Competitive substitution moves from clinical niche to routine practice in parts of the market

A precise scenario with probabilities and year-by-year net sales requires actual historical net sales and current patent end dates and litigation outcomes.

How does GLIADEL’s market exposure vary by geography and hospital type?

Geography

In US-heavy hospital oncology supply chains, the majority of revenue typically concentrates in:

• High-volume neurosurgical centers
• Integrated delivery networks with standardized formularies

International exposure depends on:

• Local regulatory approvals and product availability
• Pricing controls and reimbursement frameworks that differ by country

Without region-level sales data, any quantified geographic split cannot be made.

Hospital type

Uptake is typically higher in:

• Centers with dedicated neuro-oncology programs
• Institutions that routinely run multimodal GBM pathways including local adjuncts

Key Takeaways

• GLIADEL’s revenue dynamics are procedure-linked and institutional rather than mass-retail driven.
• Pricing pressure tends to come from hospital contracting, GPO renegotiations, and substitution within local therapy workflows.
• A complete, date-accurate exclusivity and patent risk assessment requires the current Orange Book listing content and any associated litigation or settlement dockets.
• The near-term financial trajectory is most likely stable-to-slow drift absent a patent-driven competitive shock or a shift in GBM treatment practice that increases local implant utilization.

FAQs

1) What is GLIADEL used for in glioblastoma care?

It is implanted during surgery as a local delivery approach for malignant gliomas, with use tied to neurosurgical resection pathways.

2) How do hospitals decide whether to stock or use GLIADEL?

They weigh net acquisition cost under contracts, formulary status, surgeon workflow fit, and clinical pathway alignment for eligible patients.

3) Does GLIADEL compete directly with temozolomide-based standard of care?

It competes for adjunct treatment adoption rather than replacing systemic standard regimens centered on temozolomide and radiation in typical practice.

4) What would cause a sudden GLIADEL revenue drop versus gradual decline?

A sudden drop would usually require an abrupt loss of protected market position via generic/competitive entry or a major practice guideline shift reducing local implant use.

5) What are the biggest operational drivers of GLIADEL cost to hospitals?

Sterile manufacturing constraints, logistics to OR delivery, and contract pricing structures that set net price and rebate economics.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (GLIADEL listings).
2. FDA. NDA approval documentation and related label information for GLIADEL (carmustine implant).