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: 2 brands, 5 generics; first approved May 05, 2003; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 5 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

IRESSARLDRS
ASTRAZENECANDA 2069952015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
IRESSA
ASTRAZENECANDA 0213992003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	-

Generic (ANDA) products (5)

Abbreviated applications

GEFITINIB
CIPLAANDA 2118262025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued -
GEFITINIB
NATCOANDA 2128272023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
GEFITINIB
ACTAVIS LABS FL INCANDA 2089132023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
GEFITINIB
QILU PHARM HAINANANDA 2115912023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx AB
GEFITINIB
APOTEXANDA 2095322022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	-

Listed patents

Orange Book patent file

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.

Approval history

FDA approval span

First approval

May 05, 2003

23 yr 10 mo ago

Most recent approval

May 16, 2025

1 yr 5 mo ago

Approvals span 2003–2025 across 7 FDA applications.

Brand (NDA) 229%

Generic (ANDA) 571%

Gefitinib: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ask AI about Gefitinib

Key facts