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GLUCOTROL XL Drug Profile

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Glucotrol Xl is a drug marketed by Pfizer and is included in one NDA. It is available from five 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 eighteen drug master file entries for this compound. Forty-six 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 / Packagers: see list5

Pharmacology for Tradename: GLUCOTROL XL

Ingredient-typeSulfonylurea Compounds
Drug ClassSulfonylurea

Clinical Trials for: GLUCOTROL XL

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-001Apr 26, 19945,545,413<disabled>
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-002Apr 26, 19945,545,413<disabled>
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-002Apr 26, 19945,082,668<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
5,024,843 Oral hypoglycemic glipizide granulation<disabled in preview>
5,545,413 Dosage form for administering oral hypoglycemic glipizide<disabled in preview>
6,361,795 Method for lowering blood glucose<disabled in preview>
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International Patent Family for Tradename: GLUCOTROL XL

Country Document Number Estimated Expiration
Australia632859<disabled in preview>
South Africa9006972<disabled in preview>
Greece900100659<disabled in preview>
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