Viewing data from:

GLUCOTROL XL

NDA

GLIPIZIDE | N020329 | PFIZER INC

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition Completeness Assessment Correspondence from FDA CDER to ... FDA-2023-P-4443 · 7 docket documents Hyman, Phelps & McNamara, P.C. filed a suitability petition under 21 C.F.R. §314.93(b) requesting permission to submit an Abbreviated New Drug Application for Glipizide Tablets, 15 mg, and the FDA determined the petition was complete with a review goal date of April 23, 2024, under the Generic Drugs	Suitability	2023-10-23	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

31 trials from ClinicalTrials.gov, 29 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes NCT00116831	Phase 3	Completed	GlaxoSmithKline	672	2005-01 → 2008-08
An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (0431-028)(COMPLETED)NCT00095056	Phase 3	Completed	Merck Sharp & Dohme LLC	91	2004-10 → 2006-07
Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease NCT00513630	Phase 4	Completed	Shanghai Jiao Tong University School of Medicine	304	2004-06 → 2010-07
To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies NCT01068860	Phase 2	Completed	Novartis	246	2010-02 → 2010-08
Insulin Glargine in Type 2 Diabetic Patients NCT00347100	Phase 4	Completed	Sanofi	387	2006-06
Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration NCT02911792	Phase 4	Completed	The University of Texas Health Science Center at San Antonio	72	2016-12-20 → 2023-07-11
Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients NCT00660907	Phase 3	Completed	AstraZeneca	1,217	2008-03 → 2013-01
Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia NCT01267448	Phase 4	Completed	Cook County Health	100	2014-09-09 → 2015-07-25
Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics NCT00707993	Phase 3	Completed	Takeda	441	2008-06 → 2010-08
Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management NCT02608177	N/A	Completed	University of Washington	3	2015-11 → 2018-08

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$29.20

Highest Price

$192.06

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00049-0174-02GLUCOTROL XL 5MG TAB	$38.41	FSS	Pfizer Inc.	06/30/2029
00049-0174-02GLUCOTROL XL 5MG TAB	$29.20	Big4	Pfizer Inc.	06/30/2029
00049-0174-03GLUCOTROL XL 5MG TAB,SA	$192.06	FSS	Pfizer Inc.	06/30/2029
00049-0174-03GLUCOTROL XL 5MG TAB,SA	$150.36	Big4	Pfizer Inc.	06/30/2029

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

Medicare Part D Spending

CMS annual spending data for Glucotrol XL (2024)

Total Spending

$52K

Total Claims

901

Beneficiaries

293

Avg Cost/Unit

$0.51

Spending Trend

$967K(2019)→$845K(2020)→$697K(2021)→$158K(2022)→$91K(2023)→$52K(2024)

YoY Change:-9.2%

5yr CAGR:-31.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain13 active DMFs6 inactive

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

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCGLIPIZIDE USP

DMF 24181975

CAMBREX PROFARMACO MILANO SRLGLIPIZIDE

DMF 77101988

URQUIMA SAGLIPIZIDE

DMF 100461993

USV PRIVATE LTDGLIPIZIDE USP

DMF 123741997

AMSA SPAGLIPIZIDE

DMF 131011998

FERMION OYGLIPIZIDE

DMF 151742000

TAIZHOU HIGHSUN PHARMACEUTICAL CO LTDGLIPIZIDE USP, NON-STERILE DRUG SUBSTANCE

DMF 195802006

SRI KRISHNA PHARMACEUTICALS LTDGLIPIZIDE USP

DMF 259932012

KREATIVE ORGANICS PRIVATE LTDGLIPIZIDE USP

DMF 275982013

UNICHEM LABORATORIES LTDGLIPIZIDE USP

DMF 284742014

OLON SPAGLIPIZIDE

DMF 293212015

UNIQUE CHEMICALS (A DIV OF J B CHEMICALS AND PHARMACEUTICALS LTD)GLIPIZIDE USP

DMF 349862020

DIJIA PHARMACEUTICAL GROUP CO LTDGLIPIZIDE

DMF 410352024

SUMITOMO CHEMICAL CO LTDInactiveGLIPIZIDE

DMF 88051990

FINE CHEMICALS CORP PTY LTDInactiveGLIPIZIDE

DMF 90701991

PROSTINEXInactiveGLIPIZIDE

DMF 92611991

ABBOTT LABORATORIESInactiveGLIPIZIDE

DMF 94211991

CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTDInactiveGLIPIZIDE

DMF 110241994

LUPIN LTDInactiveGLIPIZIDE USP

DMF 212102008

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Sep 13, 2021	SUPPL -35	View Letter (PDF)
Aug 17, 2018	SUPPL -32	View Letter (PDF)
Aug 29, 2017	SUPPL -30	View Letter (PDF)
Oct 6, 2015	SUPPL -29	View Letter (PDF)
Oct 16, 2013	SUPPL -28	View Letter (PDF)
Feb 9, 2011	SUPPL -25	View Letter (PDF)
Oct 29, 2008	SUPPL -22	View Letter (PDF)
Sep 29, 2003	SUPPL -15	View Letter (PDF)
Apr 1, 2002	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MG

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 26, 1994

No patent or exclusivity listings for this strength.

#002 — 10MG

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 26, 1994

#003 — 2.5MG

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 10, 1999