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Details for Generic Name: glipizide

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Glipizide is the generic ingredient in five branded drugs marketed by Mylan Pharms Inc, Par Pharm, Watson Labs, Pfizer, Accord Hlthcare, Ani Pharms Inc, Apotex, Barr Labs Inc, Mylan, Sandoz, Sun Pharm Inds Inc, Vintage Pharms Llc, Corepharma, Heritage Pharms Inc, Teva Pharms, Zydus Pharms Usa Inc, 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.

This ingredient has twenty-three patent family members in nineteen countries.

There are eighteen drug master file entries for glipizide. Eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: glipizide

Tradenames:5
Patents:1
Applicants:17
NDAs:25
Drug Master File Entries: see list18
Suppliers / Packaging: see list42
Therapeutic Class:Blood Glucose Regulators

Pharmacology for Ingredient: glipizide

Ingredient-typeSulfonylurea Compounds
Drug ClassSulfonylurea

Tentative approvals for GLIPIZIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL2.5MG
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL5MG
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL10MG

Clinical Trials for: glipizide

Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)
Status: Completed Condition: Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus
Status: Completed Condition: Type 2 Diabetes Mellitus

5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting
Status: Completed Condition: Healthy

5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Non-Fasting
Status: Completed Condition: Healthy

Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics
Status: Completed Condition: Diabetes Mellitus

Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)
Status: Completed Condition: Diabetes Mellitus, Type 2; End-Stage Kidney Disease

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare
GLIPIZIDE
glipizide
TABLET;ORAL074550-002Sep 11, 1997RXNo<disabled><disabled>
Apotex
GLIPIZIDE
glipizide
TABLET;ORAL075795-002Jun 13, 2001RXNo<disabled><disabled>
Corepharma
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide; metformin hydrochloride
TABLET;ORAL077507-001Oct 27, 2005RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: glipizide

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-002Apr 26, 19945,082,668<disabled>
Pfizer
GLUCOTROL
glipizide
TABLET;ORAL017783-002May 8, 19843,669,966<disabled>
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-003Aug 10, 19994,612,008<disabled>
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International Patent Family for Ingredient: glipizide

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)9103247Mar 21, 1991
Ireland903166Mar 13, 1991
Norway920740Feb 25, 1992
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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