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CINACALCET HYDROCHLORIDE

ANDA

CINACALCET HYDROCHLORIDE | A206125 | AUROBINDO PHARMA LTD

3 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Amgen Inc. v. Amneal Pharmaceuticals et al 1:2016cv00853 1 patentANDA 206125cinacalcet hydrochloride	D. Del.	2016-09-22	Terminated 2020-09-08	—

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

API Supply Chain22 active DMFs3 inactive

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

TEVA PHARMACEUTICAL INDUSTRIES LTDCINACALCET HYDROCHLORIDE

DMF 212642008

MEDICHEM MANUFACTURING (MALTA) LTDCINACALCET HYDROCHLORIDE (MED-200140/M )

DMF 214052008

ACTAVIS GROUP PTC EHFCINACALCET HYDROCHLORIDE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 239102010

SYNTHIMED LABS PRIVATE LTDCINACALCET HYDROCHLORIDE

DMF 242972010

MEGAFINE PHARMA P LTDCINACALCET HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE)

DMF 248812011

JUBILANT PHARMOVA LTDCINACALCET HYDROCHLORIDE

DMF 258892012

DR REDDYS LABORATORIES LTDCINACALCET HYDROCHLORIDE

DMF 272112013

APITORIA PHARMA PRIVATE LTDCINACALCET HYDROCHLORIDE

DMF 273642013

SUN PHARMACEUTICAL INDUSTRIES LTDCINACALCET HYDROCHLORIDE

DMF 275922013

CIPLA LTDCINACALCET HYDROCHLORIDE

DMF 280512014

SOLARA ACTIVE PHARMA SCIENCES LTDCINACALCET HYDROCHLORIDE

DMF 281562014

LUPIN MANUFACTURING SOLUTIONS LTDCINACALCET HYDROCHLORIDE

DMF 291472015

PIRAMAL PHARMA LTDCINACALCET HYDROCHLORIDE

DMF 291622015

HETERO DRUGS LTDCINACALCET HYDROCHLORIDE

DMF 293992015

HOLIDAY LABS MEXICO SA DE CVCINACALCET HYDROCHLORIDE

DMF 294942015

MACLEODS PHARMACEUTICALS LTDCINACALCET HYDROCHLORIDE

DMF 296772015

ZYDUS LIFESCIENCES LTDCINACALCET HYDROCHLORIDE

DMF 297372015

MSN ORGANICS PRIVATE LTDCINACALCET HYDROCHLORIDE [ROUTE CODE "CN"]

DMF 298662015

UNICHEM LABORATORIES LTDCINACALCET HYDROCHLORIDE

DMF 303852016

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDCINACALCET HYDROCHLORIDE (YUNG SHIN)

DMF 339712019

INNOVARE LABS PRIVATE LTDCINACALCET HYDROCHLORIDE

DMF 358932021

MEHTA API PVT LTDCINACALCET HYDROCHLORIDE IH

DMF 430952025

DISHMAN CARBOGEN AMCIS LTDInactiveCINACALCET HYDROCHLORIDE

DMF 286402014

ENALTEC LABS PRIVATE LTDInactiveCINACALCET HYDROCHLORIDE

DMF 286602015

VIWIT PHARMACEUTICAL CO LTDInactiveCINACALCET HYDROCHLORIDE

DMF 301832015

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 5, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 30MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 8, 2018

No patent or exclusivity listings for this strength.

#002 — EQ 60MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 8, 2018

#003 — EQ 90MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 8, 2018