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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 eighteen 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 / Packagers: see list39

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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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
5,591,454 Method for lowering blood glucose<disabled in preview>
5,024,843 Oral hypoglycemic glipizide granulation<disabled in preview>
5,545,413 Dosage form for administering oral hypoglycemic glipizide<disabled in preview>
5,091,190 Delivery system for administration blood-glucose lowering drug<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 Publication Date
Greece1000932Mar 16, 1993
Canada2024502Mar 06, 1991
Finland104950May 15, 2000
Austria94393Oct 15, 1993
South Africa9006972Jun 26, 1991
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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.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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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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