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ERLOTINIB HYDROCHLORIDE

ANDA

ERLOTINIB HYDROCHLORIDE | A211083 | ACCORD HEALTHCARE INC

3 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
OSI Pharmaceuticals, LLC et al v. Accord Healthcare Inc., USA 1:2017cv01868 1 patentANDA 211083erlotinib hydrochloride	D. Del.	2017-12-28	Terminated 2018-05-30	—

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

API Supply Chain16 active DMFs11 inactive

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

NATCO PHARMA LTDERLOTINIB HYDROCHLORIDE

DMF 217862008

RELIANCE LIFE SCIENCES PVT LTDERLOTINIB HYDROCHLORIDE

DMF 259782012

HETERO LABS LTDERLOTINIB HYDROCHLORIDE

DMF 261162012

SICHUAN XIELI PHARMACEUTICAL CO LTDERLOTINIB HYDROCHLORIDE

DMF 263882012

APOTEX INCERLOTINIB HYDROCHLORIDE

DMF 266312013

MSN LABORATORIES PRIVATE LTDERLOTINIB HYDROCHLORIDE [ROUTE CODE - "ER"]

DMF 270422013

SHILPA PHARMA LIFESCIENCES LTDERLOTINIB HYDROCHLORIDE (ET)

DMF 291242015

HIKMA PHARMACEUTICALS LLCERLOTINIB HYDROCHLORIDE

DMF 294372015

CIPLA LTDERLOTINIB HYDROCHLORIDE

DMF 296382015

CAMBREX CHARLES CITY INCERLOTINIB HYDROCHLORIDE

DMF 298092015

ALEMBIC PHARMACEUTICALS LTDERLOTINIB HYDROCHLORIDE

DMF 303922016

SUN PHARMACEUTICAL INDUSTRIES LTDERLOTINIB HYDROCHLORIDE

DMF 309802016

MSN LABORATORIES PRIVATE LTDERLOTINIB HYDROCHLORIDE (FORM-B)

DMF 323242017

CDYMAX (INDIA) PHARMA PRIVATE LTDERLOTINIB HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE)

DMF 332262018

LAURUS LABS LTDERLOTINIB HYDROCHLORIDE

DMF 343132020

CDYMAX (INDIA) PHARMA PRIVATE LTDERLOTINIB HYDROCHLORIDE [DRUG SUBSTANCE (NON-STERILE)]

DMF 360072021

TAI HENG INDUSTRY CO LTDInactiveERLOTINIB HYDROCHLORIDE

DMF 231362009

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveERLOTINIB HYDROCHLORIDE

DMF 233452009

MYLAN LABORATORIES LTDInactiveERLOTINIB HYDROCHLORIDE

DMF 244992010

MYLAN LABORATORIES LTDInactiveERLOTINIB HYDROCHLORIDE

DMF 246692011

CADILA HEALTHCARE LTD ZYFINEInactiveERLOTINIB HYDROCHLORIDE (FORM-A)

DMF 251442011

CADILA HEALTHCARE LTDInactiveERLOTINIB HYDROCHLORIDE (FORM-B)

DMF 253142011

ASYMCHEM LIFE SCIENCE TIANJIN CO LTDInactiveERLOTINIB HYDROCHLORIDE

DMF 289862015

ESTEVE HUAYI PHARMACEUTICAL CO LTDInactiveERLOTINIB HYDROCHLORIDE

DMF 294092015

QILU ANTIBIOTICS LINYI PHARMACEUTICAL CO LTDInactiveERLOTINIB HYDROCHLORIDE

DMF 296792015

INTAS PHARMACEUTICALS LTDInactiveERLOTINIB HYDROCHLORIDE

DMF 308852016

FIS FABBRICA ITALIANA SINTETICI SPAInactiveERLOTINIB HYDROCHLORIDE

DMF 321972017

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 17, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 25MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 2, 2020

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 2, 2020

#003 — EQ 150MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 2, 2020