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Last Updated: November 22, 2024

GLIADEL Drug Patent Profile


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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 11th, 2018.

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Summary for GLIADEL
Drug patent expirations by year for GLIADEL
Drug Prices for GLIADEL

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Recent Clinical Trials for GLIADEL

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

SponsorPhase
Michele Aizenberg, MDPhase 2
Arbor Pharmaceuticals, Inc.Phase 2
M.D. Anderson Cancer CenterPhase 1/Phase 2

See all GLIADEL clinical trials

Pharmacology for GLIADEL
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating 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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for GLIADEL

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

Country Patent Number Title Estimated Expiration
Denmark 0476045 ⤷  Sign Up
Canada 2073561 POLYANHYDRIDES D'ACIDES ALIPHATIQUES OLIGOMERISES INSATURATES (POLYANHYDRIDES OF THE OLIGOMERIZED UNSATURATED ALIPHATIC ACIDS) ⤷  Sign Up
Japan 2626717 ⤷  Sign Up
Norway 940837 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 9015586 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GLIADEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0260415 SPC/GB01/013 United Kingdom ⤷  Sign Up 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
0260415 C990036 Netherlands ⤷  Sign Up PRODUCT NAME: CARMUSTINE; NAT. REGISTRATION NO/DATE: RVG 24056 19990809; FIRST REGISTRATION: FR 561 907-5 19981210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.