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:	106
Clinical Trials:	45
Patent Applications:	5,086
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
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/004326 Carmustine 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
European Patent Office	0476045	POLYMERES POUVANT S'ERODER BIOLOGIQUEMENT POUR LIBERATION DE MEDICAMENTS DANS LES OS (BIOERODIBLE POLYMERS FOR DRUG DELIVERY IN BONE)
World Intellectual Property Organization (WIPO)	9110696
Japan	H05505632
Canada	2056384	POLYMERES BIOERODABLES POUR LA LIBERATION DE MEDICAMENTS DANS LES OS (BIOERODIBLE POLYMERS FOR DRUG DELIVERY IN BONE)

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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GLIADEL Wafer

Overview of GLIADEL Wafer

GLIADEL Wafer, also known as BiCNU or carmustine implant, is a locally delivered chemotherapy used in the treatment of glioblastoma multiforme (GBM), a type of brain cancer. The wafer is implanted during surgery to deliver carmustine directly to the tumor site, reducing the need for systemic chemotherapy and its associated side effects.

Market Size and Growth

The global glioblastoma multiforme drugs market, which includes GLIADEL Wafer, is expected to experience significant growth. By 2031, this market is projected to reach $2.9 billion, growing at a CAGR of 12.8% driven by an increasing geriatric population, rising incidence of glioblastoma cases, and a robust pipeline of new products[1].

Product Development and Commercialization

GLIADEL Wafer has undergone several key developments and changes in its commercialization:

• Initial Approval and Commercialization: GLIADEL Wafer was initially approved for use in recurrent GBM treatment. Guilford Pharmaceuticals, the original developer, successfully completed a large Phase III clinical trial, which generated significant revenue and led to the reacquisition of marketing and sales rights from Aventis in 2000[2].
• Transition to Arbor Pharmaceuticals: In 2012, Eisai Inc. divested the U.S. rights for GLIADEL Wafer to Arbor Pharmaceuticals. This transition included the transfer of the New Drug Application (NDA) and all regulatory obligations, as well as a long-term supply agreement where Eisai would manufacture the product for Arbor[4].

Financial Performance

The financial performance of GLIADEL Wafer has been influenced by several factors:

• Revenue Generation: The reacquisition of GLIADEL Wafer by Guilford Pharmaceuticals in 2000 generated over $60 million in revenue. This move also enabled Guilford to increase annual sales and cash flow without sharing proceeds with a partner[2].
• Market Expansion: Arbor Pharmaceuticals, after acquiring the U.S. rights, planned to increase promotional and medical support for GLIADEL Wafer, aiming to maximize its current use and explore additional clinical studies for expanded indications. This strategy is expected to drive further revenue growth[4].

Market Segmentation and Share

The glioblastoma multiforme drugs market is segmented by product, with GLIADEL Wafer being one of the key products alongside Avastin (bevacizumab) and Temodar (temozolomide). While Temodar accounts for the largest share of the market, Avastin has been the fastest-growing segment. GLIADEL Wafer, however, remains a significant player, particularly in the surgical implant segment[1].

Geographical Distribution

Geographically, the North America region, particularly the U.S. and Canada, accounts for the largest share of the GBM market. This is partly due to the presence of several GBM-related associations and organizations that promote awareness and early diagnosis, thereby driving treatment demand[1].

Clinical Pipeline and Future Prospects

The future prospects of GLIADEL Wafer are tied to ongoing clinical studies and the potential for expanded indications:

• Current Use: GLIADEL Wafer is currently used in the post-operative treatment of GBM. Arbor Pharmaceuticals is committed to supporting ongoing clinical studies and pursuing additional development opportunities[4].
• Pipeline Therapies: The overall glioblastoma multiforme market is seeing significant advancements in pipeline therapies, including targeted therapy, gene therapy, and immunotherapy. While these developments may impact the market share of existing treatments like GLIADEL Wafer, they also present opportunities for combination therapies and new indications[1][3].

Reimbursement and Coverage

Reimbursement for GLIADEL Wafer is an important aspect of its market dynamics:

• Hospital Billing: Hospitals are required to indicate the number of GLIADEL Wafers implanted on claim forms, and specific revenue codes are used for cost reporting purposes. This ensures that the treatment is covered by payers, facilitating patient access[5].

Key Takeaways

• Market Growth: The glioblastoma multiforme drugs market, including GLIADEL Wafer, is expected to grow significantly, driven by increasing incidence and a strong pipeline of new products.
• Commercialization: The transition of GLIADEL Wafer's U.S. rights to Arbor Pharmaceuticals has enhanced its commercial potential through increased promotional and medical support.
• Financial Performance: GLIADEL Wafer has generated substantial revenue and is expected to continue contributing to the financial growth of its manufacturers and distributors.
• Clinical Prospects: Ongoing clinical studies and potential expanded indications are crucial for the future success of GLIADEL Wafer.

FAQs

Q: What is GLIADEL Wafer used for? A: GLIADEL Wafer is used in the treatment of glioblastoma multiforme (GBM), a type of brain cancer, by delivering carmustine directly to the tumor site during surgery.

Q: Who currently holds the U.S. rights for GLIADEL Wafer? A: Arbor Pharmaceuticals holds the U.S. rights for GLIADEL Wafer, having acquired them from Eisai Inc. in 2012[4].

Q: How is GLIADEL Wafer reimbursed? A: GLIADEL Wafer is reimbursed through hospital billing, with specific revenue codes used for cost reporting purposes. Hospitals must indicate the number of wafers implanted on claim forms[5].

Q: What are the future prospects for GLIADEL Wafer? A: The future prospects include ongoing clinical studies and potential expanded indications, as well as the possibility of combination therapies with other emerging treatments[1][3].

Q: How does GLIADEL Wafer fit into the broader glioblastoma multiforme market? A: GLIADEL Wafer is a significant player in the surgical implant segment of the glioblastoma multiforme drugs market, alongside other key products like Avastin and Temodar[1].

Sources

1. Global Glioblastoma Multiforme Drugs Market: iHealthcareAnalyst.
2. Guilford Pharmaceuticals Annual Report: Guilford Pharmaceuticals Inc.
3. Glioblastoma Multiforme Market Insights: DelveInsight.
4. Eisai Inc. Divests U.S. Rights for GLIADEL Wafer: PR Newswire.
5. Reimbursement for GLIADEL Wafer: Gliadel.com.