Is there a generic for Gefitinib?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Gefitinib, referencing the brand IRESSA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Gefitinib?

IRESSA (NDA 206995, ASTRAZENECA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Gefitinib are approved?

Gefitinib is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Gefitinib

Gefitinib is approved as 2 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:IRESSA · NDA 206995

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
IRESSARLD	ASTRAZENECA	NDA 206995	AB	Jul 13, 2015
IRESSA	ASTRAZENECA	NDA 021399	—	May 05, 2003

Generic (ANDA) products (5)

Product	Applicant	Application	TE	Approved
GEFITINIB	CIPLA	ANDA 211826	—	May 16, 2025
GEFITINIB	NATCO	ANDA 212827	AB	May 31, 2023
GEFITINIB	ACTAVIS LABS FL INC	ANDA 208913	AB	Apr 26, 2023
GEFITINIB	QILU PHARM HAINAN	ANDA 211591	AB	Feb 13, 2023
GEFITINIB	APOTEX	ANDA 209532	—	Sep 23, 2022

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Gefitinib — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo