IRESSA Market Exclusivity Period (MEP). When will the patents on IRESSA expire, and when will generic IRESSA be available?

Summary for IRESSA

US Patents:	0
Applicants:	2
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	128
Clinical Trials:	232
Patent Applications:	6,896
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for IRESSA
DailyMed Link:	IRESSA at DailyMed

Drug patent expirations by year for IRESSA

Generic Entry Opportunity Date for IRESSA

Generic Entry Date for IRESSA^: Start Trial* 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.

Recent Clinical Trials for IRESSA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Beta Pharma, Inc.	Phase 3
Alpha Biopharma (Jiangsu) Co., Ltd.	Phase 2/Phase 3
Novartis	Phase 2

See all IRESSA clinical trials

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

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Glossary

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

IRESSA Drug Profile

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