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Last Updated: January 25, 2021

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GLIADEL Drug Profile

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

Gliadel is a drug marketed by Arbor Pharms Llc and is included in one NDA.

The generic ingredient in GLIADEL is carmustine. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the carmustine profile page.

US ANDA 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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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
Arbor Pharms Llc GLIADEL carmustine IMPLANT;INTRACRANIAL 020637-001 Sep 23, 1996 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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
Arbor Pharms Llc GLIADEL carmustine IMPLANT;INTRACRANIAL 020637-001 Sep 23, 1996   Start Trial   Start Trial
Arbor Pharms Llc GLIADEL carmustine IMPLANT;INTRACRANIAL 020637-001 Sep 23, 1996   Start Trial   Start Trial
Arbor Pharms Llc GLIADEL carmustine IMPLANT;INTRACRANIAL 020637-001 Sep 23, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for GLIADEL

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

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