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Serving leading biopharmaceutical companies globally:

Citi
Cantor Fitzgerald
Dow
McKinsey
Novartis
Accenture
Daiichi Sankyo
QuintilesIMS
Moodys
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Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021748

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NDA 021748 describes GLUMETZA, which is a drug marketed by Santarus Inc and is included in one NDA. It is available from three suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the GLUMETZA profile page.

The generic ingredient in GLUMETZA is metformin hydrochloride. There are forty-eight drug master file entries for this compound. Ninety-six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for NDA: 021748

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:6
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 021748

Ingredient-typeBiguanides

Suppliers and Packaging for NDA: 021748

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021748 NDA Depomed, Inc. 13913-002 13913-002-13 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13913-002-13)
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021748 NDA Depomed, Inc. 13913-003 13913-003-16 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13913-003-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jun 3, 2005TE:AB3RLD:Yes
Patent:► SubscribePatent Expiration:Sep 19, 2016Product Flag?YSubstance Flag?YDelist Request?
Patented Use:INDICATION OF TYPE II DIABETES
Patent:► SubscribePatent Expiration:Jun 20, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Sep 19, 2016Product Flag?YSubstance Flag?YDelist Request?

Expired Orange Book Patents for NDA: 021748

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005► Subscribe► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005► Subscribe► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005► Subscribe► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
US Army
Colorcon
Citi
Federal Trade Commission
AstraZeneca
Moodys
QuintilesIMS
Cantor Fitzgerald
Novartis

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