nilotinib hydrochloride · Novartis · NDA 022068

Tasigna

Earliest generic entry, as listed · earliest of 3 marketed strengths

7 Oct 2032

Blocked by patent: US 9061029 (pediatric extension).

FDA has approved 4 generic applications (ANDAs) for Tasigna, though its earliest generic-entry date is 7 Oct 2032 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 · 6 unexpired

10 Orange Book listing rows for 6 patents, including 6 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 9061029	drug substance, use U-1374, U-3231	7 Oct 2032	3 listing rows
US 9061029 listing row	drug substance, use U-1374	7 Apr 2032	3 strengths · listed 1 Dec 2016
US 9061029 listing row	drug substance, use U-3231	7 Apr 2032	3 strengths · listed 1 Dec 2016
US 9061029 listing row	pediatric extension · sets the listed date	7 Oct 2032	3 strengths
US 8163904	drug substance, drug product	23 Feb 2029	2 listing rows
US 8163904 listing row	drug substance, drug product	23 Aug 2028	3 strengths · listed 10 May 2012
US 8163904 listing row	pediatric extension	23 Feb 2029	3 strengths
US 8293756	drug product	25 Mar 2028	2 listing rows
US 8293756 listing row	drug product	25 Sep 2027	3 strengths · listed 8 Oct 2014
US 8293756 listing row	pediatric extension	25 Mar 2028	3 strengths
US 8389537	pediatric extension	18 Jan 2027	3 strengths
US 8415363	pediatric extension	18 Jan 2027	3 strengths
US 8501760	pediatric extension	18 Jan 2027	3 strengths

Exclusivities · 2 unexpired

PED	pediatric (6 months added)	23 Mar 2029
ODE-380	orphan drug (7 years)	23 Sep 2028

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

Generic approved · ANDA 218544, Msn · 022068-001Approved 19 Nov 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 209651, Hetero Labs Ltd V · 022068-001Approved 19 Nov 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 218350, Dr Reddys · 022068-001Approved 19 Nov 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 219134, Teva Pharms Inc · 022068-001Approved 26 Jun 2026Detected 25 Oct 2026Historical import

Products covered · 3

NDA · product	Form	Strength	Approved	Listed expiry
022068 · 001 · RLD	capsule, oral	EQ 200MG BASE	29 Oct 2007	7 Oct 2032
022068 · 002 · RLD	capsule, oral	EQ 150MG BASE	17 Jun 2010	7 Oct 2032
022068 · 003 · RLD	capsule, oral	EQ 50MG BASE	22 Mar 2018	7 Oct 2032

Expired or delisted (4)

US 8389537 · use U-1374 · 18 Jul 2026
US 8415363 · substance, product, use U-1374 · 18 Jul 2026
US 8415363 · substance, product, use U-1407 · 18 Jul 2026
US 8501760 · product · 18 Jul 2026