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:	127
Clinical Trials:	232
Patent Applications:	6,731
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^: See Pricing* 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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or request a copy of the full page.
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	See Pricing	See Pricing				See Pricing
Astrazeneca Pharms	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015		RX	Yes	Yes	See Pricing	See Pricing				See Pricing
>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?