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IRESSA Drug Profile

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When do Iressa patents expire, and what generic alternatives are available?

Iressa is a drug marketed by Astrazeneca and Astrazeneca Pharms and is included in two NDAs.

The generic ingredient in IRESSA is gefitinib. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gefitinib profile page.

Summary for IRESSA

US Patents:	0
Applicants:	2
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	124
Clinical Trials:	229
Patent Applications:	4,768
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for IRESSA
DailyMed Link:	IRESSA at DailyMed

Generic Entry Opportunity Date for IRESSA

Constraining patent/regulatory exclusivity:

FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST

NDA:

206995

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for IRESSA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Synonyms for IRESSA

15215-EP2269994A1

15215-EP2272827A1

15215-EP2272832A1

15215-EP2275413A1

15215-EP2277865A1

15215-EP2280006A1

15215-EP2281813A1

15215-EP2281815A1

15215-EP2287156A1

15215-EP2292234A1

15215-EP2292615A1

15215-EP2298768A1

15215-EP2298778A1

15215-EP2301533A1

15215-EP2301933A1

15215-EP2305640A2

15215-EP2305671A1

15215-EP2311807A1

15215-EP2311827A1

15215-EP2311840A1

15215-EP2316832A1

15215-EP2316833A1

184475-35-2

3-Chloro-4-Fluoro-N-[(4z)-7-Methoxy-6-(3-Morpholin-4-Ylpropoxy)quinazolin-4(1h)-Ylidene]aniline

32333-EP2281815A1

32333-EP2292615A1

32333-EP2301933A1

32333-EP2305640A2

32333-EP2305671A1

32333-EP2311827A1

4-(3-CHLORO-4-FLUOROANILINO)-7-METHOXY-6-(3-MORPHOLINOPROPOXY)QUINAZOLINE

4-(3'-chloro-4'-fluoroanilino)-7-methoxy-6-(3-morpholinopropoxy)-quinazoline

4-(3'-Chloro-4'-fluoroanilino)-7-methoxy-6-(3-morpholinopropoxy)quinazoline

4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxy-6-(3-morpholinopropoxy)quinazoline

4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-(3-(4-morpholinyl)propoxy)-

4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-(3-4-morpholin)propoxy)-

4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-

475G352

4CA-0562

6-(3-morpholinopropoxy)-N-(3-chloro-4-fluorophenyl)-7-methoxyquinazolin-4-amine

A812870

AB0000095

AB01273954_04

AB01273954-01

AB01273954-02

AB01273954-03

AB20814

ABP000855

AC-1556

AC1L3X0A

AJ-74091

AK-72948

AKOS000280752

AM20090619

AMX10169

AN-5192

AOB6917

API0002810

BC215794

BCB03_000781

BCP01365

BCP9000718

BCPP000221

BDBM5447

BR-72948

C-22438

CAS-184475-35-2

CC-28943

CCG-220642

CCRIS 9011

CG0031

CHEBI:49668

CHEMBL939

cid_123631

CJ-16232

CS-0124

CTK7A0364

CU-00000000396-1

D01977

DB00317

DSSTox_CID_21034

DSSTox_GSID_41034

DSSTox_RID_79614

DTXSID8041034

EBD446

EN002708

FC0028

FT-0081035

FT-0602325

G-4408

Gefitini; Iressa

Gefitinib

Gefitinib - Iressa

gefitinib (iressa)

Gefitinib (JAN/USAN/INN)

gefitinib (zd1839)

Gefitinib [USAN:INN:BAN]

Gefitinib [USAN]

Gefitinib for system suitability, EuropePharmacopoeia (EP) Reference Standard

Gefitinib, >=98% (HPLC)

Gefitinib, EuropePharmacopoeia (EP) Reference Standard

Gefitinib, Iressa, ZD1839

Gefitinib,ZD-1839,Iressa

Gefitinib;

Gefitinib; Iressa

Gefitinib/ZD-1839,Iressa

gefitinibum

GP9843

GTPL4941

H018

HMS2089B19

HMS3244M21

HMS3244M22

HMS3244N21

HMS3654A07

HMS3714A05

HY-50895

I01-1227

IRE

Iressa (AstraZeneca)

Iressa (TN)

Iressa(TM)

Iressa|||ZD 1839

IRRESSA

Irressat

J10250

K00240

KB-52238

KBioSS_002241

Kinome_3321

Kinome_3322

KS-00000E11

KS-1204

LS-139916

MCULE-6951584187

MFCD04307832

MFCD04307832 (98%)

MLS003899193

MolPort-000-883-335

N-(3-chloranyl-4-fluoranyl-phenyl)-7-methoxy-6-(3-morpholin-4-ylpropoxy)quinazolin-4-amine

N-(3-Chloro-4-fluoro-phenyl)-7-methoxy-6-(3-morpholin-4-ylpropoxy)quinazolin-4-amine

N-(3-chloro-4-fluoro-phenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine

N-(3-chloro-4-fluorophenyl)-7-methoxy-6-(3-morpholin-4-ylpropoxy)quinazolin-4-amine

N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine

N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-4-quinazolinamine

N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(morpholin-4-yl)propoxy]quinazolin-4-amine

NCGC00159455-02

NCGC00159455-03

NCGC00159455-04

NCGC00159455-05

NCGC00159455-06

NCGC00159455-08

NCGC00159455-09

NCGC00159455-14

nchembio866-comp14

NSC-715055

NSC-759856

NSC715055

NSC759856

Pharmakon1600-01502274

Q-201149

QCR-105

RS0033

S-2176

s1025

S65743JHBS

SC-18023

SCHEMBL7866

SMR002204119

SR-00000000262

SR-00000000262-2

SR-00000000262-3

ST2413546

STK621310

SW199108-4

SY002154

SYN1042

Tox21_111683

Tox21_111683_1

UNII-S65743JHBS

XGALLCVXEZPNRQ-UHFFFAOYSA-N

Z1551429741

ZD 1839

ZD 1839; Iressa

ZD-1839

ZD1839

ZINC19632614

US Patents and Regulatory Information for IRESSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003		DISCN	No	No
Astrazeneca Pharms	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015		RX	Yes	Yes
Astrazeneca Pharms	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015		RX	Yes	Yes

Expired US Patents for IRESSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003
Astrazeneca Pharms	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015