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GLIADEL Drug Profile
» See Plans and Pricing
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.
Summary for GLIADEL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 90 |
| Clinical Trials: | 41 |
| Patent Applications: | 4,561 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GLIADEL |
| DailyMed Link: | GLIADEL at DailyMed |
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
International Patents for GLIADEL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Africa | 9100381 | Start Trial |
| European Patent Office | 0266603 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9118940 | Start Trial |
| Denmark | 0476045 | Start Trial |
| Greece | 3022577 | Start Trial |
| Austria | 141804 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
