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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Actos (2023)

Total Spending

$948K

Total Claims

847

Beneficiaries

224

Avg Cost/Unit

$18.22

Spending Trend

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

YoY Change:+0.8%

5yr CAGR:+1.3%

Source: CMS Medicare Part D Spending by Drug (2023). 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