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PIOGLITAZONE HYDROCHLORIDE

ANDA

PIOGLITAZONE HYDROCHLORIDE | A202467 | MACLEODS PHARMACEUTICALS LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ACTOS(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Takeda Pharmaceutical Company Limited et al v. Macleods Pharmaceuticals Limited 1:2011cv03109 7 patentsANDA 202467pioglitazone	S.D.N.Y.	2011-05-06	Terminated 2011-06-02	—

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Feb 8, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 15MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 6, 2013

No patent or exclusivity listings for this strength.

#002 — EQ 30MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 6, 2013

#003 — EQ 45MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 6, 2013