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Glyburide - Generic Drug Details

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What are the generic sources for glyburide and what is the scope of glyburide patent protection?

Glyburide is the generic ingredient in seven branded drugs marketed by Sanofi Aventis Us, Actavis Elizabeth, Aurobindo Pharma, Epic Pharma Llc, Heritage Pharms Inc, Impax Labs Inc, Pharmadax Inc, Teva, Zydus Pharms Usa Inc, Dava Pharms Inc, Hikma, Mylan, Yaopharma Co Ltd, Pharmacia And Upjohn, and Bristol Myers Squibb, and is included in twenty-five NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for glyburide. Forty-two suppliers are listed for this compound.

Summary for glyburide

US Patents:	1
Tradenames:	7
Applicants:	15
NDAs:	25
Drug Master File Entries:	20
Suppliers / Packagers:	42
Bulk Api Vendors:	99
Clinical Trials:	61
Patent Applications:	6,552
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for glyburide
DailyMed Link:	glyburide at DailyMed

Pharmacology for glyburide

Ingredient-type	Sulfonylurea Compounds
Drug Class	Sulfonylurea

Medical Subject Heading (MeSH) Categories for glyburide

Hypoglycemic Agents

Synonyms for glyburide

(5-chloro-2-methoxyphenyl)-N-[2-(4-{[(cyclohexylamino)carbonylamino]sulfonyl}p henyl)ethyl]carboxamide

1-((p-(2-(5-Chloro-o-anisamido)ethyl)phenyl)sulfonyl)-3-cyclohexyl urea

1-((p-(2-(5-Chloro-o-anisamido)ethyl)phenyl)sulfonyl)-3-cyclohexylurea

1-(p-(2-(5-Chloro-2-methoxybenzamido)ethyl)benzenesulfonyl)-3-cyclohexylurea

1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea

1-{4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzenesulfonyl}-3-cyclohexylurea;1-{4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzenesulfonyl}-3-cyclohexylurea

10238-21-8

5-Chloro-N-(2-(4-((((cyclohexylamino)carbonyl)amino)sulfonyl)phenyl)ethyl)-2-methoxybenzamide

5-Chloro-N-(2-[4-(([(cyclohexylamino)carbonyl]amino)sulfonyl)phenyl]ethyl)-2-methoxybenzamide #

5-chloro-N-(2-{4-[(cyclohexylcarbamoyl)sulfamoyl]phenyl}ethyl)-2-methoxybenzamide

5-chloro-N-(2-{4-[N-(N-cyclohexylcarbamoyl)sulfamoyl]phenyl}ethyl)-2-methoxybenzamide

5-Chloro-N-(4-(N-(cyclohexylcarbamoyl)sulfamoyl)-phenethyl)-2-methoxybenzamide

5-Chloro-N-(4-(N-(cyclohexylcarbamoyl)sulfamoyl)phenethyl)-2-methoxybenzamide

5-chloro-N-[2-(4-{[(cyclohexylcarbamoyl)amino]sulfonyl}phenyl)ethyl]-2-methoxybenzamide

5-chloro-N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-2-methoxy-benzamide

5-chloro-N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-2-methoxybenzamide

5-Chloro-N-[2-[4-[[[(cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxybenzamide

5-Chloro-N-[2-[4-[[[(Cylcohexylamino)carbonyl]amino]sulphonyl]phenyl]ethyl]-2-methoxybenzamide

5-chloro-N-[4-({[(cyclohexylamino)carbonyl]amino}sulfonyl)phenethyl]-2-methoxybenzamide

5-Chloro-N-[4-(3-cyclohexylureidosulfonyl)phenethyl]-2-methoxybenzamide

5-Chloro-N-[4-(cyclohexylureidosulfonyl)phenethyl]-2-methoxybenzamide

78637-EP2270001A1

78637-EP2270011A1

78637-EP2272825A2

78637-EP2272841A1

78637-EP2275414A1

78637-EP2287165A2

78637-EP2287166A2

78637-EP2292620A2

78637-EP2298750A1

78637-EP2298776A1

78637-EP2298779A1

78637-EP2301923A1

78637-EP2301936A1

78637-EP2305648A1

78637-EP2308847A1

AB00051949

AB00051949_18

AB00051949_19

AB00051949-16

AB00051949-17

AB0012611

AB2000243

Abbenclamide

AC1L1G1Q

AC1Q44V7

ACMC-20a66i

Adiab

AJ-23371

AK-56404

AKOS001487495

AN-20367

ANW-58936

AOB6214

Apo-Glibenclamide

Azuglucon

Bastiverit

BCP9000729

BDBM50012957

Benclamin

Benzamide, 5-chloro-N-(2-(4-((((cyclohexylamino)carbonyl)amino)sulfonyl)phenyl)ethyl)-2-methoxy-

Benzamide, 5-chloro-N-[2-[4-[[[(cyclohexylamino) carbonyl]amino]sulfonyl]phenyl]ethyl] -2-methoxy-

Benzamide, 5-chloro-N-[2-[4-[[[(cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxy-

Betanase

Betanese 5

BG0207

BIDD:GT0239

Bio-0156

Bio1_000076

Bio1_000565

Bio1_001054

Bio2_000071

Bio2_000551

BPBio1_000344

BRD-K36927236-001-06-0

BRN 2230085

BSPBio_000312

BSPBio_001351

BSPBio_003053

C-22898

C07022

C23H28ClN3O5S

Calabren

CAS-10238-21-8

CBiol_001790

CCG-39618

CHEBI:5441

CHEMBL472

CPD000058229

CS-1075

CTK8B7917

Cytagon

D00336

D05LYX

Daonil

Daonil (TN)

DB01016

Debtan

Delmide

Dia-basan

Diabeta

Diabeta (TN)

Diabiphage

Dibelet

DivK1c_000481

DR003043

DSSTox_CID_17237

DSSTox_GSID_37237

DSSTox_RID_79313

DTXSID0037237

Duraglucon

EINECS 233-570-6

EU-0100499

Euclamin

Euglucan

Euglucon

Euglucon (TN)

Euglucon 5

Euglucon N

Euglykon

FT-0601608

G 0639

G0382

GBM

GBN 5

Gen-Glybe

Gewaglucon

GIBENCLAMIDE

Gilemal

Glamide

Glibadone

Gliban

Gliben

Gliben-Puren N

Glibenbeta

Glibenclamid AL

Glibenclamid Basics

Glibenclamid Fabra

Glibenclamid Genericon

Glibenclamid Heumann

Glibenclamid Riker M

Glibenclamid Riker M.

Glibenclamid-Cophar

Glibenclamid-Ratiopharm

Glibenclamida

Glibenclamida [INN-Spanish]

Glibenclamide

Glibenclamide (JP15/INN)

Glibenclamide (JP17/INN)

Glibenclamide 1.0 mg/ml in Acetonitrile

Glibenclamide B.P.

Glibenclamide for peak identification, European Pharmacopoeia (EP) Reference Standard

Glibenclamidum

Glibenclamidum [INN-Latin]

Glibenil

Glibens

Glibesyn

Glibet

Glibetic

Glibil

Gliboral

Glicem

glicuformine

Glidiabet

Glimel

Glimide

Glimidstata

Glisulin

Glitisol

Glubate

Gluben

Gluco-Tablimen

Glucobene

Glucohexal

Glucolon

Glucomid

Glucoremed

Glucovance

Glucoven

Glyben

Glybenclamide

Glybenclamide, >=99% (HPLC)

Glybenclamide, European Pharmacopoeia (EP) Reference Standard

Glybenzcyclamide

Glybenzcyclamide, 99%

glyburide (glibenclamide)

Glyburide (Glibenclamide), pharmaceutical secondary standard; traceable to USP, PhEur and BP

Glyburide (micronized)

Glyburide (USP)

Glyburide [USAN:USP]

Glyburide [USAN]

Glyburide, meets USP testing specifications

Glyburide, United States Pharmacopeia (USP) Reference Standard

Glycolande

Glycomin

Glycron

Glynase

Glynase (TN)

GP8701

GTPL2414

HB 419

HB 420

HB-419

HB-420

HB419

HB420

HD 419

Hemi-Daonil

Hexaglucon

HMS1361D13

HMS1568P14

HMS1791D13

HMS1922L08

HMS1989D13

HMS2089L06

HMS2093P04

HMS2095P14

HMS3259O12

HMS3261D19

HMS3267A15

HMS3402D13

HMS3428D15

HMS3651E17

HMS501I03

Humedia

HY-15206

I06-0716

IDI1_000481

IDI1_033821

J10021

KB-73471

KBio1_000481

KBio2_000071

KBio2_000730

KBio2_002639

KBio2_003298

KBio2_005207

KBio2_005866

KBio3_000141

KBio3_000142

KBio3_002273

KBioGR_000071

KBioGR_001897

KBioSS_000071

KBioSS_000730

KS-5326

Lederglib

Libanil

Lisaglucon

Lopac-G-0639

Lopac0_000499

LP00499

LS-159295

Maninil

MCULE-2351642942

Med-Glionil

Melix

MFCD00056625

Micronase

Micronase (TN)

Micronized glyburide

Miglucan

MLS000069721

MLS001077262

MolPort-000-784-850

N-(4-(.beta.-(2-Methoxy-5-chlorbenzamido)-aethyl)-benzolsulfonyl)-N'-cyclohexyl-harnstoff

N-(4-(2-(5-Chloro-2-methoxybenzamido)ethyl)phenylsulfonyl)-N'-cyclohexylurea

N-(4-(beta-(2-Methoxy-5-chlorbenzamido)-aethyl)-benzolsulfonyl)-N'-cyclohexyl-harnstoff

N-[(4-{2-[(5-chloro-2-methoxyphenyl)carbonylamino]ethyl}phenyl)sulfonyl](cyclo hexylamino)carboxamide

N-p-[2-(5-Chloro-2-methoxybenzamido)-ethyl]benzene-sulfonyl-N -cyclohexylurea

N-p-[2-(5-Chloro-2-methoxybenzamido)-ethyl]benzene-sulfonyl-N-cyclohexylurea

N-p-[2-(5-Chloro-2-methoxybenzamido)-ethyl]benzene-sulfonyl-N'-cyclohexylurea

N-p-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulfonyl-N'-cyclohexylurea

Nadib

NC00566

NCGC00015467-01

NCGC00015467-02

NCGC00015467-03

NCGC00015467-04

NCGC00015467-05

NCGC00015467-06

NCGC00015467-07

NCGC00015467-08

NCGC00015467-09

NCGC00015467-10

NCGC00015467-11

NCGC00015467-12

NCGC00015467-13

NCGC00015467-14

NCGC00015467-15

NCGC00015467-16

NCGC00015467-17

NCGC00015467-18

NCGC00015467-20

NCGC00016689-01

NCGC00023447-02

NCGC00023447-04

NCGC00023447-05

NCGC00023447-06

NCGC00023447-07

NCGC00023447-08

NCGC00023447-09

NCGC00023447-10

NCGC00023447-11

NCGC00023447-12

NCGC00254662-01

NCGC00261184-01

Neogluconin

NINDS_000481

Norglicem 5

Normoglucon

Novo-Glyburide

NSC-759618

NSC759618

Opera_ID_801

Oprea1_764617

OR194620

Orabetic

Pharmakon1600-02300229

Pira

Praeciglucon

PresTab

Prestwick_569

Prestwick0_000316

Prestwick1_000316

Prestwick2_000316

Prestwick3_000316

Probes1_000431

Probes2_000378

Prodiabet

Renabetic

RT-000122

S1716

SAM002564212

SBB057426

SBI-0050483.P003

SC-17437

SCHEMBL22009

Semi-daonil

Semi-Daonil (TN)

Semi-Euglucon

Semi-Gliben-Puren N

SMR000058229

SPBio_001831

SPBio_002531

Spectrum_000250

Spectrum2_001816

SPECTRUM2300229

Spectrum3_001327

Spectrum4_001199

Spectrum5_001631

SR-01000000196

SR-01000000196-2

SR-01000000196-5

ST024780

STK362992

Sugril

Suraben

SX6K58TVWC

SYN3026

Tiabet

Tocris-0911

Tox21_110158

Tox21_110158_1

Tox21_300758

Tox21_500499

U 26452

U-26,452

U-26452

UNII-SX6K58TVWC

UPCMLD-DP006

UPCMLD-DP006:001

UR 606

Urea, 1-((p-(2-(chloro-o-anisamido)ethyl)phenyl)sulfonyl)-3-cyclohexyl-

Urea, 1-(p-(2-(5-chloro-2-methoxybenzamido)ethyl)benzenesulfonyl)-3-cyclohexyl-

W-108874

W-5054

Yuglucon

Z277540138

ZINC537805

ZNNLBTZKUZBEKO-UHFFFAOYSA-N

US Patents and Regulatory Information for glyburide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Elizabeth	GLYBURIDE	glyburide	TABLET;ORAL	075947-001	Nov 14, 2002		DISCN	No	No
Pharmacia And Upjohn	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992	AB	RX	Yes	No
Bristol Myers Squibb	GLUCOVANCE	glyburide; metformin hydrochloride	TABLET;ORAL	021178-003	Jul 31, 2000		DISCN	Yes	No					Y
Actavis Elizabeth	GLYBURIDE AND METFORMIN HYDROCHLORIDE	glyburide; metformin hydrochloride	TABLET;ORAL	076716-002	Jun 28, 2005	AB	RX	No	No

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Expired US Patents for glyburide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-003	May 1, 1984
Pharmacia And Upjohn	MICRONASE	glyburide	TABLET;ORAL	017498-002	May 1, 1984
Pharmacia And Upjohn	GLYNASE	glyburide	TABLET;ORAL	020051-001	Mar 4, 1992
Pharmacia And Upjohn	GLYNASE	glyburide	TABLET;ORAL	020051-004	Sep 24, 1993

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