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TARCEVA

NDA

ERLOTINIB HYDROCHLORIDE | N021743 | OSI PHARMACEUTICALS LLC

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

3 cases 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	—
Arch Development Corp. et al v. Genentech, Inc. 1:2015cv06597 1 patenterlotinib	N.D. Ill.	2015-07-28	Terminated 2018-09-18	—
OSI Pharmaceuticals LLC et al v. Roxane Laboratories Inc. 1:2012cv01669 4 patentsANDA 203843erlotinib hydrochloride	D. Del.	2012-12-07	Terminated 2013-09-16	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 1 recruiting, 2 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer NCT01708954	Phase 2	Active	National Cancer Institute (NCI)	125	2013-02-13 → 2027-03-31
Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)NCT02193282	Phase 3	Active	National Cancer Institute (NCI)	390	2015-02-11 → 2027-02-03
Erlotinib for Hepatocellular Carcinoma Chemoprevention NCT04172779	Phase 2	Not Yet Recruiting	University of Texas Southwestern Medical Center	60	2026-12 → 2030-08

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

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

17 letters from Drugs@FDA

Date	Submission	Document
Oct 20, 2016	SUPPL -25	View Letter (PDF)
Sep 30, 2016	SUPPL -26	View Letter (PDF)
Jun 6, 2016	SUPPL -27	View Letter (PDF)
May 24, 2016	SUPPL -23	View Letter (PDF)
Apr 29, 2015	SUPPL -21	View Letter (PDF)
Apr 16, 2014	SUPPL -19	View Letter (PDF)
May 16, 2013	SUPPL -18	View Letter (PDF)
Apr 19, 2012	SUPPL -17	View Letter (PDF)
Apr 20, 2010	SUPPL -16	View Letter (PDF)
Apr 20, 2010	SUPPL -14	View Letter (PDF)
May 5, 2009	SUPPL -15	View Letter (PDF)
Sep 23, 2008	SUPPL -11	View Letter (PDF)
Sep 16, 2008	SUPPL -10	View Letter (PDF)
Sep 16, 2008	SUPPL -8	View Letter (PDF)
May 7, 2007	SUPPL -7	View Letter (PDF)
Nov 3, 2005	SUPPL -3	View Letter (PDF)
Dec 2, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 18, 2004

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 18, 2004

#003 — EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 18, 2004