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Glipizide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for glipizide?

Glipizide is the generic ingredient in five branded drugs marketed by Sandoz, Barr Labs Inc, Unique Pharm Labs, 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-six 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. Fifty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: glipizide

Tradenames:5
Patents:2
Applicants:18
NDAs:26
Drug Master File Entries: see list18
Suppliers / Packagers: see list53
Bulk Api Vendors: see list72
Clinical Trials: see list14
Patent Applications: see list5,642
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:glipizide at DailyMed

Pharmacology for Ingredient: glipizide

Ingredient-typeSulfonylurea Compounds
Drug ClassSulfonylurea

Tentative approvals for GLIPIZIDE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL2.5MG
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL5MG
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL10MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms Usa Inc
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide; metformin hydrochloride
TABLET;ORAL078905-002Jan 31, 2011RXNoNo► Subscribe► Subscribe
Accord Hlthcare
GLIPIZIDE
glipizide
TABLET;ORAL074550-001Sep 11, 1997RXNoNo► Subscribe► Subscribe
Bristol Myers Squibb
METAGLIP
glipizide; metformin hydrochloride
TABLET;ORAL021460-003Oct 21, 2002DISCNYesNo► Subscribe► Subscribe
Corepharma
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide; metformin hydrochloride
TABLET;ORAL077507-002Oct 27, 2005RXNoNo► Subscribe► Subscribe
Mylan
GLIPIZIDE
glipizide
TABLET;ORAL074438-001Jun 20, 1995RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: glipizide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-002Apr 26, 19944,327,725► Subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-001Apr 26, 19944,327,725► Subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-003Aug 10, 19995,591,454► Subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-003Aug 10, 19995,545,413► Subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-003Aug 10, 19995,024,843► Subscribe
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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► Subscribe
5,024,843 Oral hypoglycemic glipizide granulation► Subscribe
5,091,190 Delivery system for administration blood-glucose lowering drug► Subscribe
5,591,454 Method for lowering blood glucose► Subscribe
5,545,413 Dosage form for administering oral hypoglycemic glipizide► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: glipizide

Country Document Number Estimated Expiration
Mexico171191► Subscribe
Ireland903166► Subscribe
Denmark0490991► Subscribe
Austria94393► Subscribe
Greece1000932► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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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