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Details for Generic Name: glipizide

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Glipizide is the generic ingredient in five branded drugs marketed by Par Pharm, Watson Labs, Pfizer, Accord Hlthcare, Apotex, Barr Labs Inc, Ivax Sub Teva Pharms, Mylan, Sandoz, Sun Pharm Inds Inc, Teva, Vintage Pharms Llc, Corepharma, Heritage Pharms Inc, Teva Pharms, Zydus Pharms Usa Inc, and Bristol Myers Squibb, and is included in twenty-four 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 seventeen 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:24
Drug Master File Entries: see list17
Suppliers: see list8
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

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
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms Usa Inc
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide; metformin hydrochloride
TABLET;ORAL078905-001Jan 31, 2011RXNo<disabled><disabled>
Teva Pharms
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide; metformin hydrochloride
TABLET;ORAL077270-002Oct 28, 2005RXNo<disabled><disabled>
Accord Hlthcare
GLIPIZIDE
glipizide
TABLET;ORAL074550-002Sep 11, 1997RXNo<disabled><disabled>
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-001Apr 26, 1994RXNoRE44459<disabled><disabled>
Mylan
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide; metformin hydrochloride
TABLET;ORAL078083-002Apr 12, 2007RXNo<disabled><disabled>
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International Patent Family for Ingredient: glipizide

Country Document Number Publication Date
Ireland903166Mar 13, 1991
Germany69003392Oct 21, 1993
JapanH05500222Jan 21, 1993
Australia632859Jan 14, 1993
Japan2919964Jul 19, 1999
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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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