ponatinib hydrochloride · Takeda Pharms Usa · NDA 203469

Iclusig

Earliest generic entry, as listed · earliest of 4 marketed strengths

12 Dec 2033

Blocked by patent: US 11192895, US 11192895, US 11192895, US 11192897, US 11192897, US 11192897, US 11384086, US 11384086, US 11384086, US 9493470, US 9493470.

Listed patents · 17 unexpired

Patent	Claims	Expires	Notes
US 11192895	use U-1700	12 Dec 2033	4 strengths · listed 6 Jan 2022
US 11192895	use U-1948	12 Dec 2033	4 strengths · listed 6 Jan 2022
US 11192895	use U-1701	12 Dec 2033	4 strengths · listed 6 Jan 2022
US 11192897	substance, use U-1700	12 Dec 2033	4 strengths · listed 6 Jan 2022
US 11192897	substance, use U-1948	12 Dec 2033	4 strengths · listed 6 Jan 2022
US 11192897	substance, use U-1701	12 Dec 2033	4 strengths · listed 6 Jan 2022
US 11384086	substance, product, use U-1701	12 Dec 2033	4 strengths · listed 3 Aug 2022
US 11384086	substance, product, use U-1700	12 Dec 2033	4 strengths · listed 3 Aug 2022
US 11384086	substance, product, use U-1948	12 Dec 2033	4 strengths · listed 3 Aug 2022
US 9493470	substance, product, use U-1700	12 Dec 2033	4 strengths · listed 29 Nov 2016
US 9493470	substance, product, use U-1948	12 Dec 2033	4 strengths · listed 29 Nov 2016
US 8114874	substance, product	24 Jan 2027	4 strengths
US 9029533	use U-1283	22 Dec 2026	4 strengths · listed 9 Jun 2015
US 9029533	use U-1699	22 Dec 2026	4 strengths · listed 9 Jun 2015
US 9029533	use U-1701	22 Dec 2026	4 strengths · listed 9 Jun 2015
US 9029533	use U-1700	22 Dec 2026	4 strengths · listed 9 Jun 2015
US 9029533	use U-836	22 Dec 2026	4 strengths · listed 9 Jun 2015

Exclusivities · 2 unexpired

ODE-472	orphan drug (7 years)	19 Mar 2031
I-934	new indication (3 years)	19 Mar 2027

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

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 4

NDA · product	Form	Strength	Approved	Listed expiry
203469 · 001 · RLD	tablet, oral	EQ 15MG BASE	14 Dec 2012	12 Dec 2033
203469 · 002 · RLD	tablet, oral	EQ 45MG BASE	14 Dec 2012	12 Dec 2033
203469 · 003 · RLD	tablet, oral	EQ 30MG BASE	23 Apr 2015	12 Dec 2033
203469 · 004 · RLD	tablet, oral	EQ 10MG BASE	18 Dec 2020	12 Dec 2033