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Serving leading biopharmaceutical companies globally:

McKinsey
Chinese Patent Office
Moodys
Cantor Fitzgerald
Johnson and Johnson
Queensland Health
Medtronic
Farmers Insurance
Julphar
Baxter

Generated: January 19, 2018

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. One hundred and five suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 021748
Tradename:GLUMETZA
Applicant:Santarus Inc
Ingredient:metformin hydrochloride
Patents:6
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 021748
Ingredient-typeBiguanides
Medical Subject Heading (MeSH) Categories for 021748
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)

Profile 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 US Patents for NDA 021748

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 ➤ Subscribe ➤ Subscribe
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 ➤ Subscribe ➤ Subscribe
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 ➤ Subscribe ➤ Subscribe
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

UBS
Deloitte
Novartis
US Department of Justice
Cantor Fitzgerald
Johnson and Johnson
Express Scripts
AstraZeneca
Chinese Patent Office

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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