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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
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McKinsey
Citi
Fish and Richardson
QuintilesIMS
Healthtrust
US Army
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Generated: July 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021410

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NDA 021410 describes AVANDAMET, which is a drug marketed by Sb Pharmco and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the AVANDAMET profile page.

The generic ingredient in AVANDAMET is metformin hydrochloride; rosiglitazone maleate. There are forty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.
Summary for 021410
Tradename:AVANDAMET
Applicant:Sb Pharmco
Ingredient:metformin hydrochloride; rosiglitazone maleate
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021410
Generic Entry Date for 021410*:
Constraining patent/regulatory exclusivity:
Dosage::
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021410
Suppliers and Packaging for NDA: 021410
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410 NDA Physicians Total Care, Inc. 54868-4965 E 54868-4965-0
AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410 NDA Physicians Total Care, Inc. 54868-4965 E 54868-4965-1

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 10, 2002TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 7, 2022Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 10, 2002TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 7, 2022Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 10, 2002TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 7, 2022Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021410

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-002 Oct 10, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-001 Oct 10, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-001 Oct 10, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-003 Oct 10, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Chubb
Covington
AstraZeneca
Dow
Express Scripts
Daiichi Sankyo
Boehringer Ingelheim
Fuji

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