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DIABETA

NDA

GLYBURIDE | N017532 | SANOFI AVENTIS US LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

56 trials from ClinicalTrials.gov, 42 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment NCT00046462	Phase 3	Completed	Sanofi	240	2001-11 → 2004-12
Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fed NCT00835991	Phase 1	Completed	Teva Pharmaceuticals USA	60	2003-02 → 2003-02
A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers NCT01733108	Phase 1	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	29	2008-07 → 2008-09
Safety Study of Pioglitazone Compared To Glyburide on Liver Function NCT00494312	Phase 4	Completed	Takeda	2,120	2000-10 → 2005-06
Effect of Rosiglitazone on Myocardial Blood Flow Regulation in Type 2 Diabetes NCT00549874	N/A	Completed	University of Michigan	27	2002-02 → 2006-11
A Relative Bioavailability Study of Glyburide/Metformin HCl 5 mg/500 mg Tablets Under Fasting Conditions NCT00865436	Phase 1	Completed	Actavis Inc.	36	2004-04 → 2004-04
Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes NCT00451620	Phase 2	Completed	University of British Columbia	30	2003-11 → 2011-09
The Drug -Drug Interaction of SP2086 and Glyburide NCT02815787	Phase 1	Completed	Jiangsu HengRui Medicine Co., Ltd.	16	2014-03 → 2014-07
Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide NCT00279045	Phase 3	Completed	GlaxoSmithKline	4,426	2000-01-03 → 2006-06-19
Efficacy of Pioglitazone Compared to Glyburide in Treating Subjects With Type 2 Diabetes Mellitus and Mild Cardiac Disease NCT00521742	Phase 3	Completed	Takeda	300	2001-03 → 2003-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$0.0742

per ea

Lowest NADAC/Unit

$0.0599

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00093947753GLYBURIDE 1.25 MG TABLET	$0.0742	EA	Generic	—	2026-06-17
00093943301GLYBURIDE 2.5 MG TABLET	$0.0657	EA	Generic	—	2026-06-17
00093936401GLYBURIDE 5 MG TABLET	$0.0599	EA	Generic	—	2026-06-17
00093936410GLYBURIDE 5 MG TABLET	$0.0599	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$4.03

Highest Price

$213.42

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00093-9477-53GLYBURIDE 1.25MG TAB	$7.19	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-9477-53GLYBURIDE 1.25MG TAB	$4.03	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-9364-01GLYBURIDE 5MG TAB	$22.46	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-9364-01GLYBURIDE 5MG TAB	$8.70	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-9364-10GLYBURIDE 5MG TAB	$213.42	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-9364-10GLYBURIDE 5MG TAB	$109.73	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-9433-01GLYBURIDE 2.5MG TAB	$4.05	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-9433-01GLYBURIDE 2.5MG TAB	$4.05	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain7 active DMFs9 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

CAMBREX PROFARMACO MILANO SRLGLYBURIDE

DMF 76751988

USV PRIVATE LTDGLYBURIDE USP

DMF 158212002

CADILA PHARMACEUTICALS LTDGLYBURIDE USP

DMF 170932004

APITORIA PHARMA PRIVATE LTDGLYBURIDE USP

DMF 171522004

ZENTIVA KSGLYBURIDE USP (GLIBENCLAMIDE), MILLED

DMF 180182005

SRI KRISHNA PHARMACEUTICALS LTDGLYBURIDE USP

DMF 270452013

TIANJIN PHARMACEUTICAL HOLDINGS GENCOM PHARMACY CO LTDGLYBURIDE

DMF 299212015

FARMOS GROUP LTD MEDIPOLARInactiveGLYBURIDE

DMF 76381988

CADILA LABORATORIES PVT LTDInactiveGLYBURIDE BP'88 (GLIBENCLAMIDE)

DMF 79891989

SELOC FRANCEInactiveGLYBURIDE

DMF 110551994

HOECHST CELANESE CORPInactiveGLYBURIDE

DMF 111791994

AVENTIS PHARMA DEUTSCHLAND GMBHInactiveGLYBURIDE [MILLED (GROUND)]

DMF 121361996

AVENTIS PHARMA DEUTSCHLAND GMBHInactiveGLYBURIDE (MICRONIZED) BULK DRUG SUBSTANCE

DMF 121651996

USV LTDInactiveGLYBURIDE

DMF 143391999

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveGLYBURIDE USP

DMF 182662005

CADILA HEALTHCARE LTDInactiveGLYBURIDE

DMF 192362006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jan 18, 2017	SUPPL -38	View Letter (PDF)
Oct 16, 2013	SUPPL -34	View Letter (PDF)
Jul 15, 2009	SUPPL -30	View Letter (PDF)
Mar 10, 2009	SUPPL -28	View Letter (PDF)
Mar 10, 2009	SUPPL -27	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 1.25MG

RLDAB2

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 1, 1984

No patent or exclusivity listings for this strength.

#002 — 2.5MG

RLDAB2

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 1, 1984

#003 — 5MG

RLDAB2

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 1, 1984