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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Covington
Boehringer Ingelheim
Deloitte
Dow
Julphar
Baxter
McKesson
Colorcon

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022024

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NDA 022024 describes ACTOPLUS MET XR, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ACTOPLUS MET XR profile page.

The generic ingredient in ACTOPLUS MET XR is metformin hydrochloride; pioglitazone hydrochloride. There are forty-eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.
Summary for 022024
Tradename:ACTOPLUS MET XR
Applicant:Takeda Pharms Usa
Ingredient:metformin hydrochloride; pioglitazone hydrochloride
Patents:11
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022024
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024 NDA Takeda Pharmaceuticals America, Inc. 64764-310 N 64764-310-07
ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024 NDA Takeda Pharmaceuticals America, Inc. 64764-310 N 64764-310-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM;EQ 15MG BASE
Approval Date:May 12, 2009TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 17, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN

Expired US Patents for NDA 022024

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 ➤ 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:

Chubb
US Army
QuintilesIMS
Harvard Business School
McKinsey
Fuji
Johnson and Johnson
Cantor Fitzgerald
Cerilliant

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