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GLIADEL Drug Profile

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Which patents cover Gliadel, and what generic alternatives are available?

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. Seven 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 January 23^rd, 2020.

Summary for GLIADEL

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	80
Clinical Trials:	40
Patent Applications:	6,722
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GLIADEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLIADEL
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
M.D. Anderson Cancer Center	Phase 1/Phase 2
Ohio State University Comprehensive Cancer Center	Phase 1/Phase 2
Fred Hutchinson Cancer Research Center	Phase 1

See all GLIADEL clinical trials

Recent Litigation for GLIADEL

Identify potential future generic entrants

District Court Litigation

Case Name	Date
SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC.	2015-01-16

See all GLIADEL litigation

Pharmacology for GLIADEL

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Synonyms for GLIADEL

1-(2-Chloroethyl)-1-([(2-chloroethyl)amino]carbonyl)-2-oxohydrazine #

1,3-Bis(.beta.-chloroethyl)-1-nitrosourea

1,3-bis(2-chloroethyl)-1-nitroso-urea

1,3-Bis(2-chloroethyl)-1-nitrosourea

1,3-bis(2-chloroethyl)-3-nitrosourea

1,3-Bis(2-chloroethyl)nitrosourea

1,3-Bis(beta-chloroethyl)-1-nitrosourea

1,3-BIS(CHLOROETHYL)-1-NITROSOUREA

1159711-15-5

1191292-23-5

13167-EP2270014A1

13167-EP2272827A1

13167-EP2272832A1

13167-EP2275420A1

13167-EP2277876A1

13167-EP2292614A1

13167-EP2295055A2

13167-EP2295416A2

13167-EP2295426A1

13167-EP2295427A1

13167-EP2298748A2

13167-EP2298764A1

13167-EP2298765A1

13167-EP2298768A1

13167-EP2298778A1

13167-EP2305642A2

13167-EP2308861A1

13167-EP2311453A1

13167-EP2311808A1

13167-EP2311825A1

13167-EP2311829A1

13167-EP2311842A2

13167-EP2314590A1

13167-EP2316832A1

13167-EP2316833A1

13167-EP2316834A1

13167-EP2374454A1

15164-EP2272827A1

15164-EP2316832A1

15164-EP2316833A1

154-93-8

154C938

4CA-0349

A809590

AB00052431_08

AB00052431-07

AB0011283

AB2000140

ABP000292

AC-24196

AC1L1DZQ

AI3-52216

AKOS005558013

AN-1123

ANW-61236

AOB6824

AS-12106

BCNU

BCNU [Chloroethyl nitrosoureas]

BCNU; 1,3-Bis(2-chloroethyl)-1-nitrosourea

BCP27690

BCP9000490

BDBM50015950

Becenum

Becenun

Bi CNU

BiCNU

BiCNU (TN)

Bis-N,N'-(chloroethyl)nitrosourea

Bis(2-chloroethyl)1-nitrosourea

Bis(2-chloroethyl)nitrosourea

Bis(chloroethyl)nitrosourea

Bischlorethylnitrosourea

Bischlorethylnitrosurea

Bischloroethyl nitrosourea

Bischloroethyl nitrosourea [Chloroethyl nitrosoureas]

Bischloroethylnitrosourea

BRN 2049744

C 0400

C06873

C5H11Cl2N3O2

C5H9Cl2N3O2

Carmubris

Carmustin

Carmustina

Carmustina [INN-Spanish]

carmustine

Carmustine (JAN/USAN/INN)

Carmustine [USAN:INN:BAN]

Carmustine [USAN:USP:INN:BAN]

carmustine in ethanol

Carmustine, >=98%

Carmustine, United States Pharmacopeia (USP) Reference Standard

Carmustine(BiCNU)

Carmustine(BiCNU)/

Carmustinum

Carmustinum [INN-Latin]

Carustine

CAS-154-93-8

CCG-39925

CCRIS 810

CHEBI:3423

CHEMBL513

CS-2935

CTK8B8775

D00254

DB00262

DivK1c_000835

DLGOEMSEDOSKAD-UHFFFAOYSA-N

DSSTox_CID_2743

DSSTox_GSID_22743

DSSTox_RID_76712

DTI 015

DTXSID8022743

EINECS 205-838-2

EU-0100188

FDA 0345

FIVB

FT-0083563

FT-0602937

Gliadel (MGI Pharm)

Gliadel (TN)

Gliadel Wafer

Gliadel;BCNU;NSC-409962;Becenun;BiCNU

GTPL6800

HMS2092J22

HMS2230I05

HMS3260F17

HMS3369D17

HMS502J17

HSDB 7761

HY-13585

I14-11976

IDI1_000835

KB-216399

KBio1_000835

KBio2_000745

KBio2_003313

KBio2_005881

KBioGR_001296

KBioSS_000745

Lopac-C-0400

Lopac0_000188

LP00188

LS-890

MCULE-3131772074

MFCD00057706

MLS001333962

MolPort-003-665-505

N,N'-BIS(2-CHLOROETHYL)-N-NITROSOUREA

N,N''-Bis(2-chloroethyl)-N-nitrosourea

NCGC00015204-01

NCGC00015204-02

NCGC00015204-03

NCGC00015204-04

NCGC00015204-05

NCGC00015204-06

NCGC00015204-07

NCGC00015204-08

NCGC00015204-09

NCGC00093665-01

NCGC00093665-02

NCGC00093665-03

NCGC00093665-04

NCGC00260873-01

NCI-C04773

NCI60_003931

NINDS_000835

Nitrumon

NSC 409962

NSC-409962

NSC-758392

NSC409962

NSC758392

Pharmakon1600-01503110

Prestwick_997

SBI-0050176.P003

SC-17305

SCHEMBL4503

SK 27702

SMR000058426

Spectrum_000265

Spectrum4_000888

Spectrum5_000920

SR-01000075736

SR-01000075736-1

SR-01000075736-3

SRI 1720

ST24036755

STK624770

TC-149981

Tox21_110097

Tox21_110097_1

Tox21_500188

U68WG3173Y

UNII-U68WG3173Y

Urea, 1,3-bis(2-chloroethyl)-1-nitroso-

Urea, N,N'-bis(2-chloroethyl)-N-nitroso-

Urea,3-bis(2-chloroethyl)-1-nitroso-

Urea,N'-bis(2-chloroethyl)-N-nitroso-

W-108025

WLN: ONN2GVM2G

Z1563145982

ZINC3830387

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

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
Arbor Pharms Llc	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996
Arbor Pharms Llc	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996