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Last Updated: October 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021925

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NDA 021925 describes DUETACT, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DUETACT profile page.

The generic ingredient in DUETACT is glimepiride; pioglitazone hydrochloride. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the glimepiride; pioglitazone hydrochloride profile page.
Summary for 021925
Tradename:DUETACT
Applicant:Takeda Pharms Usa
Ingredient:glimepiride; pioglitazone hydrochloride
Patents:2
Pharmacology for NDA: 021925
Suppliers and Packaging for NDA: 021925
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925 NDA Takeda Pharmaceuticals America, Inc. 64764-302 64764-302-30 30 TABLET in 1 BOTTLE (64764-302-30)
DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925 NDA Takeda Pharmaceuticals America, Inc. 64764-302 64764-302-90 90 TABLET in 1 BOTTLE (64764-302-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG;30MG
Approval Date:Jul 28, 2006TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 30, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 8, 2028Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG;30MG
Approval Date:Jul 28, 2006TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 30, 2027Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021925

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