axitinib · Pf Prism Cv · NDA 202324

Inlyta

Earliest generic entry, as listed · earliest of 2 marketed strengths

12 Jul 2037

Blocked by patent: US 10869924 (pediatric extension).

FDA has approved 1 generic application (ANDA) for Inlyta, though its earliest generic-entry date is 12 Jul 2037 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 4 unexpired

9 Orange Book listing rows for 4 patents, including 4 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 10869924	use U-3044	12 Jul 2037	2 listing rows
US 10869924 listing row	use U-3044	12 Jan 2037	2 strengths · listed 21 Jan 2021
US 10869924 listing row	pediatric extension · sets the listed date	12 Jul 2037	2 strengths
US 10570202	use U-2844	3 Aug 2035	2 listing rows
US 10570202 listing row	use U-2844	3 Feb 2035	2 strengths · listed 30 Jun 2020
US 10570202 listing row	pediatric extension	3 Aug 2035	2 strengths
US 12534530	use U-4411, U-4412	3 Aug 2035	3 listing rows
US 12534530 listing row	use U-4411	3 Feb 2035	2 strengths · listed 23 Feb 2026
US 12534530 listing row	use U-4412	3 Feb 2035	2 strengths · listed 23 Feb 2026
US 12534530 listing row	pediatric extension	3 Aug 2035	2 strengths
US 8791140	drug substance	14 Jun 2031	2 listing rows
US 8791140 listing row	drug substance	14 Dec 2030	2 strengths
US 8791140 listing row	pediatric extension	14 Jun 2031	2 strengths

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

First generic approved · ANDA 211650, Apotex · 202324-001Approved 30 Oct 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 211650, Apotex · 202324-001Approved 30 Oct 2025Detected 25 Oct 2026Historical import
Generic tentatively approved · ANDA 219705, Sandoz Inc · 202324-001Tentative approval 7 Oct 2025Detected 25 Oct 2026Historical import

Products covered · 2

NDA · product	Form	Strength	Approved	Listed expiry
202324 · 001 · RLD	tablet, oral	1MG	27 Jan 2012	12 Jul 2037
202324 · 002 · RLD	tablet, oral	5MG	27 Jan 2012	12 Jul 2037