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Glipizide - Generic Drug Details

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Glipizide is the generic ingredient in five branded drugs marketed by Sandoz, Barr Labs Inc, Sun Pharm Inds Inc, Watson Labs, Mylan, Pfizer, Accord Hlthcare, Par Pharm, Vintage Pharms Llc, Ani Pharms Inc, Apotex, Mylan Pharms Inc, Zydus Pharms Usa Inc, Corepharma, Heritage Pharms Inc, Bristol Myers Squibb, and Teva Pharms, 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. Forty-six 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 list46
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

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>
Bristol Myers Squibb
METAGLIP
glipizide; metformin hydrochloride
TABLET;ORAL021460-002Oct 21, 2002DISCNNo<disabled><disabled>
Ani Pharms Inc
GLIPIZIDE
glipizide
TABLET;ORAL074497-001Aug 31, 1995RXNo<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;ORAL020329-001Apr 26, 19945,545,413<disabled>
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-002Apr 26, 19945,545,413<disabled>
Pfizer
GLUCOTROL
glipizide
TABLET;ORAL017783-001May 8, 19843,669,966<disabled>
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Non-Orange Book Patents for Generic Ingredient: glipizide

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>
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International Patent Family for Ingredient: glipizide

Country Document Number Estimated Expiration
JapanH05500222<disabled in preview>
Norway920740<disabled in preview>
Greece900100659<disabled in preview>
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