Is there a generic for Axitinib?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Axitinib, referencing the brand INLYTA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Axitinib?

INLYTA (NDA 202324, PF PRISM CV) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Axitinib?

The Orange Book lists 8 patents against Axitinib products, with the earliest listed expiry in 2030. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Axitinib are approved?

Axitinib is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Axitinib

Axitinib: 1 brand, 1 generic; first approved Jan 27, 2012; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Dec 14, 2030

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 14, 2030

in 4 yr 5 mo

Brand (NDA) products

Originator applications

INLYTARLD
PF PRISM CVNDA 20232420122 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Rx —
5MG TABLET ORAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	—
5MG	TABLET	ORAL	Rx	—

Generic (ANDA) products (1)

Abbreviated applications

AXITINIB
APOTEXANDA 21165020252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8791140	Dec 14, 2030	in 4 yr 5 mo	Substance
8791140*PED	Jun 14, 2031	in 4 yr 11 mo
12534530	Feb 03, 2035	in 8 yr 7 mo	U-4411
10570202	Feb 03, 2035	in 8 yr 7 mo	U-2844
12534530*PED	Aug 03, 2035	in 9 yr 1 mo
10570202*PED	Aug 03, 2035	in 9 yr 1 mo
10869924	Jan 12, 2037	in 10 yr 7 mo	U-3044
10869924*PED	Jul 12, 2037	in 11 yr 1 mo

Approval history

FDA approval span

First approval

Jan 27, 2012

14 yr 9 mo ago

Most recent approval

Oct 30, 2025

10 mo ago

Approvals span 2012–2025 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Axitinib: 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.

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