Details for New Drug Application (NDA): 206995

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NDA 206995 describes IRESSA, which is a drug marketed by Astrazeneca and Astrazeneca Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the IRESSA profile page.

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 206995

Tradename:	IRESSA
Applicant:	Astrazeneca Pharms
Ingredient:	gefitinib
Patents:	0
Formulation / Manufacturing:	see details

Generic Entry Opportunity Date for 206995

Generic Entry Date for 206995^: ➤ Sign Up* 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 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 NDA: 206995

Mechanism of Action	Protein Kinase Inhibitors

Suppliers and Packaging for NDA: 206995

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IRESSA	gefitinib	TABLET;ORAL	206995	NDA	AstraZeneca Pharmaceuticals LP	0310-0482	0310-0482-30	30 TABLET, COATED in 1 BOTTLE (0310-0482-30)
IRESSA	gefitinib	TABLET;ORAL	206995	NDA	AstraZeneca Pharmaceuticals LP	0310-0482	0310-0482-93	30 TABLET, COATED in 1 BOTTLE (0310-0482-93)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jul 13, 2015	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 13, 2022
Regulatory Exclusivity Use:	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
Regulatory Exclusivity Expiration:	Jul 13, 2018
Regulatory Exclusivity Use:	NEW PRODUCT

Expired US Patents for NDA 206995

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Pharms	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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