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Last Updated: December 7, 2019

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 seven 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-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.
Summary for 022024
Pharmacology for NDA: 022024
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 64764-310-07 1 BLISTER PACK in 1 CARTON (64764-310-07) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024 NDA Takeda Pharmaceuticals America, Inc. 64764-310 64764-310-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64764-310-30)
Paragraph IV (Patent) Challenges for 022024
Tradename Dosage Ingredient NDA Submissiondate
ACTOPLUS MET XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride; pioglitazone hydrochloride 022024 2011-09-23

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM;EQ 15MG BASE
Approval Date:May 12, 2009TE:RLD:Yes
Patent:  Start 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
Patent:  Start TrialPatent Expiration:Mar 17, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jul 31, 2026Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022024

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