Viewing data from:

DUETACT

NDA

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE | N021925 | TAKEDA PHARMACEUTICALS USA INC

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expiring < 1yr (1)Active (1)Today

2027

2028

Today

7700128

Jan. 30, 2027

8071130

Jun. 8, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin NCT00576784	Phase 4	Completed	IKFE Institute for Clinical Research and Development	100	2005-04 → 2007-04
Efficacy of Pioglitazone and Glimepiride Combination Therapy in Treating Subjects With Type 2 Diabetes Mellitus.NCT00770952	Phase 3	Completed	Takeda	91	2006-12 → 2008-12
Pioglitazone Decreases Visceral Fat Metabolism NCT01819402	N/A	UNKNOWN	Kurume University	60	2012-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$10.97

per ea

Lowest NADAC/Unit

$10.78

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66993082230PIOGLITAZONE-GLIMEPIRIDE 30-4	$10.97	EA	Generic	—	2026-06-17
66993082130PIOGLITAZONE-GLIMEPIRIDE 30-2	$10.78	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (4 FSS, 2 Big4)

Lowest Price

$124.29

Highest Price

$449.31

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66993-0821-30GLIMEPIRIDE 2MG/PIOGLITAZONE HCL 30MG TAB	$343.01	FSS	Prasco, LLC	06/30/2026
66993-0821-30GLIMEPIRIDE 2MG/PIOGLITAZONE HCL 30MG TAB	$124.29	Big4	Prasco, LLC	06/30/2026
66993-0822-30GLIMEPIRIDE 4MG/PIOGLITAZONE HCL 30MG TAB	$343.01	FSS	Prasco, LLC	06/30/2026
66993-0822-30GLIMEPIRIDE 4MG/PIOGLITAZONE HCL 30MG TAB	$134.10	Big4	Prasco, LLC	06/30/2026
64764-0302-30DUETACT 30MG/2MG TABLETS	$449.31	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
64764-0304-30DUETACT 30MG/4MG TABLETS	$434.77	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2017	SUPPL -17	View Letter (PDF)
Dec 13, 2016	SUPPL -16	View Letter (PDF)
Mar 17, 2015	SUPPL -15	View Letter (PDF)
Nov 14, 2013	SUPPL -6	View Letter (PDF)
Nov 14, 2013	SUPPL -14	View Letter (PDF)
May 22, 2012	SUPPL -12	View Letter (PDF)
Aug 4, 2011	SUPPL -11	View Letter (PDF)
Aug 4, 2011	SUPPL -10	View Letter (PDF)
Sep 28, 2010	SUPPL -8	View Letter (PDF)
Oct 26, 2009	SUPPL -7	View Letter (PDF)
Jan 6, 2009	SUPPL -5	View Letter (PDF)
Oct 4, 2007	SUPPL -4	View Letter (PDF)
Oct 4, 2007	SUPPL -3	View Letter (PDF)
Sep 11, 2007	SUPPL -2	View Letter (PDF)
Feb 12, 2007	SUPPL -1	View Letter (PDF)
Aug 4, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 2MG;30MG

RLDAB

2 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 28, 2006

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7700128	Jan 30, 2027	—	—	Yes	—	—
8071130	Jun 8, 2028	—	—	Yes	—	—

#002 — 4MG;30MG

RLDAB

2 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 28, 2006