cabazitaxel · Sanofi Aventis Us · NDA 201023

Jevtana Kit

Earliest generic entry, as listed

27 Apr 2031

Blocked by patent: US 10583110 (pediatric extension), US 10716777 (pediatric extension), US 12453712 (pediatric extension), US 8927592 (pediatric extension).

Listed patents · 4 unexpired

8 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 10583110	use U-2753	27 Apr 2031	2 listing rows
US 10583110 listing row	use U-2753	27 Oct 2030	listed 17 Mar 2020
US 10583110 listing row	pediatric extension · sets the listed date	27 Apr 2031
US 10716777	use U-2856	27 Apr 2031	2 listing rows
US 10716777 listing row	use U-2856	27 Oct 2030	listed 21 Jul 2020
US 10716777 listing row	pediatric extension · sets the listed date	27 Apr 2031
US 12453712	use U-4334	27 Apr 2031	2 listing rows
US 12453712 listing row	use U-4334	27 Oct 2030	listed 28 Nov 2025
US 12453712 listing row	pediatric extension · sets the listed date	27 Apr 2031
US 8927592	use U-3200	27 Apr 2031	2 listing rows
US 8927592 listing row	use U-3200	27 Oct 2030	listed 12 Jan 2015
US 8927592 listing row	pediatric extension · sets the listed date	27 Apr 2031

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

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

Products covered · 1

NDA · product	Form	Strength	Approved	Listed expiry
201023 · 001 · RLD	solution, intravenous	60MG/1.5ML (40MG/ML)	17 Jun 2010	27 Apr 2031

Expired or delisted (2)

US 7241907 · — · 10 Jun 2026
US 7241907 · substance · 10 Dec 2025