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Serving leading biopharmaceutical companies globally:

Novartis
Fish and Richardson
Medtronic
Chubb
AstraZeneca
Boehringer Ingelheim
Queensland Health
Johnson and Johnson
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Generated: November 21, 2017

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Glipizide - Generic Drug Details

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What are the generic sources for glipizide and what is the scope of glipizide freedom to operate?

Glipizide
is the generic ingredient in five branded drugs marketed by Sandoz, Barr Labs Inc, Unique Pharm Labs, Sun Pharm Inds Inc, Watson Labs Teva, Mylan, Aurobindo Pharma Ltd, Pfizer, Accord Hlthcare, Par Pharm, Watson Labs, Vintage Pharms Llc, Ani Pharms Inc, Apotex, Mylan Pharms Inc, Zydus Pharms Usa Inc, Epic Pharma Llc, Heritage Pharms Inc, Bristol Myers Squibb, and Teva Pharms, and is included in twenty-seven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Glipizide has twenty-four patent family members in nineteen countries.

There are eighteen drug master file entries for glipizide. Fifty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for glipizide

Ingredient-typeSulfonylurea Compounds
Drug ClassSulfonylurea

Medical Subject Heading (MeSH) Categories for glipizide

Tentative approvals for GLIPIZIDE

Applicant Application No. Strength Dosage Form
u► Subscribe2.5MGTABLET, EXTENDED RELEASE;ORAL
u► Subscribe10MGTABLET, EXTENDED RELEASE;ORAL
u► Subscribe5MGTABLET, EXTENDED RELEASE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan
GLIPIZIDE
glipizide
TABLET;ORAL074438-001Jun 20, 1995ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
GLIPIZIDE
glipizide
TABLET, EXTENDED RELEASE;ORAL202298-002May 19, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
GLIPIZIDE
glipizide
TABLET, EXTENDED RELEASE;ORAL076467-002Nov 7, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide; metformin hydrochloride
TABLET;ORAL077270-003Oct 28, 2005ABRXNoYes► Subscribe► Subscribe► Subscribe
Mylan
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide; metformin hydrochloride
TABLET;ORAL078083-003Apr 12, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Heritage Pharms Inc
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide; metformin hydrochloride
TABLET;ORAL078728-003Jun 23, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Vintage Pharms Llc
GLIPIZIDE
glipizide
TABLET;ORAL074378-001Nov 28, 1994DISCNNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide; metformin hydrochloride
TABLET;ORAL077620-003Jan 11, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex
GLIPIZIDE
glipizide
TABLET;ORAL075795-001Jun 13, 2001ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide; metformin hydrochloride
TABLET;ORAL077620-002Jan 11, 2008ABRXNoNo► Subscribe► 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, 1994► Subscribe► Subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-001Apr 26, 1994► Subscribe► Subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-001Apr 26, 1994► Subscribe► Subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-003Aug 10, 1999► Subscribe► Subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-002Apr 26, 1994► Subscribe► Subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-003Aug 10, 1999► Subscribe► Subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-003Aug 10, 1999► Subscribe► Subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-002Apr 26, 1994► Subscribe► Subscribe
Pfizer
GLUCOTROL
glipizide
TABLET;ORAL017783-001May 8, 1984► Subscribe► Subscribe
Pfizer
GLUCOTROL XL
glipizide
TABLET, EXTENDED RELEASE;ORAL020329-001Apr 26, 1994► Subscribe► 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
5,024,843 Oral hypoglycemic glipizide granulation► Subscribe
5,591,454 Method for lowering blood glucose► Subscribe
6,361,795 Method for lowering blood glucose► Subscribe
5,545,413 Dosage form for administering oral hypoglycemic glipizide► Subscribe
5,091,190 Delivery system for administration blood-glucose lowering drug► 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
South Korea0157640► Subscribe
Austria94393► Subscribe
Denmark0490991► Subscribe
Ireland62594► Subscribe
World Intellectual Property Organization (WIPO)9103247► Subscribe
South Africa9006972► Subscribe
Greece1000932► Subscribe
Norway920740► Subscribe
Portugal95169► Subscribe
New Zealand235127► 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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Serving leading biopharmaceutical companies globally:

Julphar
Novartis
Chubb
Federal Trade Commission
Accenture
Citi
Cipla
Merck
Medtronic
Express Scripts

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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