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ACTOS

NDA

PIOGLITAZONE HYDROCHLORIDE | N021073 | TAKEDA PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

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

7 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Takeda Pharmaceutical Company Limited et al v. Hetero Drugs Limited et al 1:2011cv08302 7 patentsANDA 203467pioglitazone	S.D.N.Y.	2011-11-16	Terminated 2012-03-05	—
Takeda Pharmaceuticals Company Limited et al v. Apotex, Inc. et al 1:2011cv01514 7 patentsANDA 202502pioglitazone	S.D.N.Y.	2011-03-04	Terminated 2011-04-15	—
Takeda Pharmaceutical Company Limited et al v. Cadila Healthcare Ltd. et al 1:2011cv00315 7 patentsANDA 20-2456pioglitazone	S.D.N.Y.	2011-01-14	Terminated 2011-03-23	—
Takeda Pharmaceuticals Company Limited et al v. Synthon Pharmaceuticals, Inc. et al 1:2010cv06679 7 patentsANDA 78-472pioglitazone	S.D.N.Y.	2010-09-08	Terminated 2010-12-21	—
Takeda Pharmaceutical Company Limited et al v. Dr. Reddy's Laboratories, Limited et al 1:2010cv04168 7 patentsANDA 78-383pioglitazone	S.D.N.Y.	2010-05-20	Terminated 2010-08-23	—
TAKEDA PHARMACEUTICAL COMPANY LIMITED et al v. AUROBINDO PHARMA LIMITED et al 2:2010cv00319 7 patentsANDA 020268pioglitazone	D.N.J.	2010-01-19	Terminated 2010-02-17	—
Takeda Pharmaceutical Company Limited et al v. Aurobindo Pharma Limited et al 1:2010cv00247 7 patentsANDA 20-0268pioglitazone	S.D.N.Y.	2010-01-13	Terminated 2010-05-11	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Takeda Pharmaceuticals North America - Citizen Petition FDA-2007-P-0294 · 7 docket documents Takeda Pharmaceuticals North America filed this citizen petition requesting that the FDA not grant final approval to any abbreviated new drug application for generic pioglitazone hydrochloride unless the labeling includes information for both monotherapy and combination therapy use, consistent with	505(q)	2008-04-23	Open	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

340 trials from ClinicalTrials.gov — 5 recruiting, 2 active, 254 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate Cancer NCT02592317	Phase 1	Active	Aragon Pharmaceuticals, Inc.	23	2016-02-12 → 2027-12-31
HbA1c Variability in Type II Diabetes NCT02879409	N/A	Active	Weill Cornell Medical College in Qatar	150	2016-11 → 2026-10-01
Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients NCT03471117	Phase 4	Recruiting	The University of Texas at Arlington	28	2018-04-01 → 2026-04-01
Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)NCT03109288	Phase 1/2	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	250	2017-08-11 → 2029-01-01
Insulin Regulation of Lipolysis and Lipolysis Proteins NCT03866408	Early Phase 1	Recruiting	Mayo Clinic	64	2018-11-12 → 2026-12-31
Dapagliflozin Plus Pioglitazone in T1DM NCT03878459	Phase 4	Recruiting	The University of Texas Health Science Center at San Antonio	120	2019-08-08 → 2027-12
Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)NCT02969798	N/A	Recruiting	The University of Texas Health Science Center at San Antonio	700	2014-01-01 → 2027-07
Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage NCT00827892	Phase 2	Completed	The University of Texas Health Science Center, Houston	84	2009-03 → 2013-11
Pioglitazone in Early Parkinson's Disease NCT01280123	Phase 2	Completed	University of Rochester	210	2011-03 → 2014-05
Pioglitazone and Metformin in Diabetic Children NCT01396564	Phase 1/2	Completed	Coordinación de Investigación en Salud, Mexico	56	2005-10 → 2011-07

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

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (2 FSS, 1 Big4)

Lowest Price

$283.55

Highest Price

$470.28

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
64764-0151-04ACTOS 15MG TABLETS	$283.55	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
64764-0301-14ACTOS 30MG TABLETS	$433.93	Big4	Takeda Pharmaceuticals America, Inc.	08/14/2026
64764-0451-24ACTOS 45MG TABLETS	$470.28	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026

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

Medicare Part D Spending

CMS annual spending data for Actos (2024)

Total Spending

$650K

Total Claims

625

Beneficiaries

168

Avg Cost/Unit

$16.54

Spending Trend

$2.3M(2019)→$2.1M(2020)→$1.7M(2021)→$1.4M(2022)→$948K(2023)→$650K(2024)

YoY Change:-9.2%

5yr CAGR:-1.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain19 active DMFs9 inactive

17 active API suppliers hold Drug Master Files for this ingredient.

BIOCON LTDPIOGLITAZONE HYDROCHLORIDE USP

DMF 166352003

CIPLA LTDPIOGLITAZONE HYDROCHLORIDE USP

DMF 166722003

USV PRIVATE LTDPIOGLITAZONE HYDROCHLORIDE

DMF 166842003

TAPI NL BVPIOGLITAZONE HYDROCHLORIDE

DMF 166882003

WOCKHARDT LTDPIOGLITAZONE HYDROCHLORIDE

DMF 167932003

SYNTHIMED LABS PRIVATE LTDPIOGLITAZONE HYDROCHLORIDE USP

DMF 183792005

USV PRIVATE LTDPIOGLITAZONE HYDROCHLORIDE USP (EXTRA PURE)

DMF 192502006

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDPIOGLITAZONE HYDROCHLORIDE

DMF 195582006

DR REDDYS LABORATORIES LTDPIOGLITAZONE HYDROCHLORIDE USP

DMF 212952008

MATRIX PHARMACORP PRIVATE LTDPIOGLITAZONE HYDROCHLORIDE USP

DMF 214742008

ZYDUS LIFESCIENCES LTDPIOGLITAZONE HYDROCHLORIDE USP

DMF 220412008

APITORIA PHARMA PRIVATE LTDPIOGLITAZONE HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE)

DMF 228652009

PH HEALTH LTDPIOGLITAZONE HYDROCHLORIDE (NON-STERILE) DRUG SUBSTANCE

DMF 229242009

BIOCON LTDPIOGLITAZONE HYDROCHLORIDE USP

DMF 232782009

MACLEODS PHARMACEUTICALS LTDPIOGLITAZONE HYDROCHLORIDE

DMF 236682010

MSN ORGANICS PRIVATE LTDPIOGLITAZONE HYDROCHLORIDE USP [ROUTE CODE "PG"]

DMF 241812010

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDPIOGLITAZONE HYDROCHLORIDE USP

DMF 275042013

HETERO LABS LTDPIOGLITAZONE HYDROCHLORIDE (PROCESS-II)

DMF 303332016

JOYANG LABORATORIESPIOGLITAZONE HYDROCHLORIDE

DMF 428552025

DR REDDYS LABORATORIES LTDInactivePIOGLITAZONE HYDROCHLORIDE

DMF 166752003

SUN PHARMACEUTICAL INDUSTRIES LTDInactivePIOGLITAZONE HYDROCHLORIDE USP

DMF 166822003

MOREPEN LABORATORIES LTDInactivePIOGLITAZONE HYDROCHLORIDE

DMF 177012004

ERREGIERRE SPAInactivePIOGLITAZONE HYDROCHLORIDE

DMF 193432006

LUPIN LTDInactivePIOGLITAZONE HYDROCHLORIDE

DMF 196262006

HETERO LABS LTDInactivePIOGLITAZONE HYDROCHLORIDE

DMF 215342008

SIGNA SA DE CVInactivePIOGLITAZONE HYDROCHLORIDE USP

DMF 216032008

AARTI DRUGS LTDInactivePIOGLITAZONE HYDROCHLORIDE

DMF 261922012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactivePIOGLITAZONE HYDROCHLORIDE USP

DMF 277462013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

25 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2017	SUPPL -49	View Letter (PDF)
Dec 13, 2016	SUPPL -48	View Letter (PDF)
Nov 14, 2013	SUPPL -46	View Letter (PDF)
May 22, 2012	SUPPL -45	View Letter (PDF)
Aug 5, 2011	SUPPL -44	View Letter (PDF)
Aug 5, 2011	SUPPL -43	View Letter (PDF)
Jul 30, 2010	SUPPL -40	View Letter (PDF)
Oct 26, 2009	SUPPL -37	View Letter (PDF)
Dec 18, 2008	SUPPL -34	View Letter (PDF)
May 9, 2008	SUPPL -33	View Letter (PDF)
Sep 11, 2007	SUPPL -30	View Letter (PDF)
Aug 17, 2007	SUPPL -31	View Letter (PDF)
Mar 6, 2007	SUPPL -26	View Letter (PDF)
Nov 7, 2006	SUPPL -28	View Letter (PDF)
Oct 2, 2006	SUPPL -29	View Letter (PDF)
Sep 18, 2006	SUPPL -27	View Letter (PDF)
Aug 5, 2004	SUPPL -23	View Letter (PDF)
Jul 21, 2004	SUPPL -24	View Letter (PDF)
Dec 4, 2003	SUPPL -20	View Letter (PDF)
Jun 22, 2003	SUPPL -21	View Letter (PDF)
Jan 17, 2003	SUPPL -17	View Letter (PDF)
Dec 3, 2002	SUPPL -18	View Letter (PDF)
Jul 12, 2002	SUPPL -10	View Letter (PDF)
Jan 7, 2002	SUPPL -16	View Letter (PDF)
Jul 15, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 15MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 15, 1999

No patent or exclusivity listings for this strength.

#002 — EQ 30MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 15, 1999

#003 — EQ 45MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 15, 1999