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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Queensland Health
Merck
Mallinckrodt
Fuji
Novartis
Argus Health
Fish and Richardson
Federal Trade Commission
Cantor Fitzgerald
Teva

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202298

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NDA 202298 describes GLIPIZIDE, which is a drug marketed by Aurobindo Pharma Ltd, Mylan Pharms Inc, Par Pharm, Unique Pharm Labs, Watson Labs, Accord Hlthcare, Ani Pharms Inc, Apotex, Barr Labs Inc, Mylan, Sandoz, Sun Pharm Inds Inc, Vintage Pharms Llc, Watson Labs Teva, Epic Pharma Llc, Heritage Pharms Inc, Teva Pharms, and Zydus Pharms Usa Inc, and is included in twenty-four NDAs. It is available from fifty-two suppliers. Additional details are available on the GLIPIZIDE profile page.

The generic ingredient in GLIPIZIDE is glipizide; metformin hydrochloride. There are eighteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.

Summary for 202298

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 202298

Ingredient-typeSulfonylurea Compounds

Suppliers and Packaging for NDA: 202298

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIPIZIDE glipizide TABLET, EXTENDED RELEASE;ORAL 202298 ANDA Mylan Pharmaceuticals Inc. 0378-0340 0378-0340-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0340-93)
GLIPIZIDE glipizide TABLET, EXTENDED RELEASE;ORAL 202298 ANDA Mylan Pharmaceuticals Inc. 0378-0342 0378-0342-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0342-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG
Approval Date:May 19, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Jul 27, 2016
Regulatory Exclusivity Use:PATENT CHALLENGE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:May 19, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 19, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Argus Health
Merck
Johnson and Johnson
Moodys
Farmers Insurance
Accenture
UBS
Healthtrust
AstraZeneca
Medtronic

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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