Drybench Patent.

CABAZITAXEL, NDA 201023

The patents and exclusivities FDA's Orange Book lists for NDA 201023 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.

FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured: 14 October 2026
Paragraph IV list captured: 17 October 2026
Last checked: 30 October 2026
Data-branch commit: dadcab56563716abea6c5e31a5e1970080c778ef

Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.

Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.

Open in the app CABAZITAXEL in the molecule app

Listed protection

Listed dates run from 10 Dec 2025 to 27 Apr 2031, each by its own rule; no one date stands for this product.

Earliest listed date: 10 Dec 2025US 7,241,907, substance patentRule R1 · Product 001 · patent.txt line 2,319
Latest listed date: 27 Apr 2031US 8,927,592 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 2,320
Latest substance patent: 10 Jun 2026US 7,241,907 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 2,318
Latest listed patent: 27 Apr 2031US 8,927,592 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 2,320
Latest exclusivity: None listed

4 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 201023, as listed. The sections below name products by these numbers.

Product 001 · JEVTANA KIT
Dosage form; route
SOLUTION;INTRAVENOUS
Strength
60MG/1.5ML (40MG/ML)
Approval date as listed
17 Jun 2010
Type as listed
RX
Applicant as listed
SANOFI AVENTIS US INC

Listed patents

Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.

10 entries from 10 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 7,241,907, substance patent
patent.txt line 2,319
Expiry as listed
10 Dec 2025
Rule
R1
Flags
substance
Product numbers
001
US 7,241,907 with pediatric exclusivity, as listed
patent.txt line 2,318
Expiry as listed
10 Jun 2026
Rule
R2
Flags
substance · pediatric, as listed by FDA (from the base row)
Product numbers
001
US 10,583,110, use patent
patent.txt line 2,313
Expiry as listed
27 Oct 2030
Rule
R1
Flags
use code U-2753
Product numbers
001
US 10,716,777, use patent
patent.txt line 2,315
Expiry as listed
27 Oct 2030
Rule
R1
Flags
use code U-2856
Product numbers
001
US 12,453,712, use patent
patent.txt line 2,317
Expiry as listed
27 Oct 2030
Rule
R1
Flags
use code U-4334
Product numbers
001
US 8,927,592, use patent
patent.txt line 2,321
Expiry as listed
27 Oct 2030
Rule
R1
Flags
use code U-3200
Product numbers
001
US 10,583,110 with pediatric exclusivity, as listed
patent.txt line 2,312
Expiry as listed
27 Apr 2031
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 10,716,777 with pediatric exclusivity, as listed
patent.txt line 2,314
Expiry as listed
27 Apr 2031
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 12,453,712 with pediatric exclusivity, as listed
patent.txt line 2,316
Expiry as listed
27 Apr 2031
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 8,927,592 with pediatric exclusivity, as listed
patent.txt line 2,320
Expiry as listed
27 Apr 2031
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001

Listed exclusivities

Each exclusivity FDA lists for NDA 201023, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

The Orange Book capture of 14 October 2026 lists no exclusivity for NDA 201023.

Paragraph IV list rows giving NDA 201023

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 201023, each cell as listed.

FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.

The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.

Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.

Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 201023

Cabazitaxel · Injection · 60 mg/1.5 mL
RLD/NDA as listed: Jevtana Kit 201023
First PIV submission
17 Jun 2014
ANDAs
8
180-day status
Extinguished Eligible Deferred
Decision posted
1/20/2026 2/20/2023 7/25/2022
First applicant approval
23 Jun 2022
First marketing
blank
Last qualifying patent expiry (as listed by FDA)
10 Dec 2025

Notes from the trace

R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.

Patents vs FDA exclusivity How to read the Orange Book data files Paragraph IV certification What changed, by week