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Serving 500+ biopharmaceutical companies globally:

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Novartis
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Generated: June 29, 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-seven drug master file entries for this compound. Ninety-three 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:1
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:6,488,962Patent Expiration:Jun 20, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:6,635,280Patent Expiration:Sep 19, 2016Product Flag?YSubstance Flag?YDelist Request?
Patent:6,723,340Patent Expiration:Oct 25, 2021Product 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, 20056,340,475► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 20056,340,475► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 20056,635,280► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 20056,635,280► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Moodys
US Army
Federal Trade Commission
Citi
Baxter
Dow
McKinsey
QuintilesIMS
Farmers Insurance
Deloitte

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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