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Profile for Tradename: GLUCOTROL XL

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Glucotrol Xl is a drug marketed by Pfizer and is included in one NDA. It is available from seven suppliers. There is one patent protecting this drug.

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

The generic ingredient in GLUCOTROL XL is glipizide. There are seventeen drug master file entries for this compound. Eight suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the glipizide profile page.

Summary for Tradename: GLUCOTROL XL

Patents:1
Applicants:1
NDAs:1
Suppliers: see list7

Pharmacology for Tradename: GLUCOTROL XL

Ingredient-typeSulfonylurea Compounds
Drug ClassSulfonylurea

Clinical Trials for: GLUCOTROL XL

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

Combination of Sulfonylureas and Insulin Glargine Outpatient Therapy for Unstable Diabetes and Impending DKA
Status: Completed Condition: Type 2 Diabetes

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

Bioequivalence Study Of Glucotrol XL 2.5 Mg Tablets
Status: Completed Condition: Diabetes Mellitus, Non-Insulin-Dependent; Hyperglycemia

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

Cytochrome P450 2C19 Variant is Related to Pharmacokinetics of Glipizide Extended Release Tablet in Chinese Subjects
Status: Completed Condition: Genotype; Pharmacokinetic

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

Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans
Status: Recruiting Condition: Diabetes Mellitus, Type 2

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
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-002Apr 26, 1994RXYesRE44459<disabled><disabled>
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-003Aug 10, 1999RXNoRE44459<disabled><disabled>
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-001Apr 26, 1994RXNoRE44459<disabled><disabled>
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Non-Orange Book Patents for Tradename: GLUCOTROL XL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,361,795 Method for lowering blood glucose<disabled in preview>
5,545,413 Dosage form for administering oral hypoglycemic glipizide<disabled in preview>
5,024,843 Oral hypoglycemic glipizide granulation<disabled in preview>
5,591,454 Method for lowering blood glucose<disabled in preview>
5,091,190 Delivery system for administration blood-glucose lowering drug<disabled in preview>
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International Patent Family for Tradename: GLUCOTROL XL

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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