Drybench Patent.

PEXIDARTINIB HYDROCHLORIDE, NDA 211810

The patents and exclusivities FDA's Orange Book lists for NDA 211810 as captured on 14 October 2026, each date named by its rule and its rows, and any rows of FDA's Paragraph IV list captured on 17 October 2026 that give this NDA's number. 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 PEXIDARTINIB HYDROCHLORIDE in the molecule app

Listed protection

Listed dates run from 2 Aug 2026 to 24 Jul 2038, each by its own rule; no one date stands for this product.

Earliest listed date: 2 Aug 2026ODE* exclusivityRule R3 · Product 002
Source lines
exclusivity.txt line 1,002
Latest listed date: 24 Jul 2038US 10,961,240, use patentRule R1 · Products 001, 002
Source lines
patent.txt lines 13,193, 13,205
Latest substance patent: 5 May 2036US 9,802,932, substance patentRule R1 · Products 001, 002
Source lines
patent.txt lines 13,200, 13,212
Latest listed patent: 24 Jul 2038US 10,961,240, use patentRule R1 · Products 001, 002
Source lines
patent.txt lines 13,193, 13,205
Latest exclusivity: 2 Aug 2026ODE-250 exclusivityRule R3 · Product 001
Source lines
exclusivity.txt line 1,001

Listed dates of other NDAs in the same years:2026 2027 2028 2033 2036 2038

8 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 211810, as listed. The sections below name products by these numbers.

Product 001 · TURALIO
Dosage form; route
CAPSULE;ORAL
Strength
EQ 200MG BASE
Approval date as listed
2 Aug 2019
Type as listed
DISCN
Applicant as listed
DAIICHI SANKYO INC
Product 002 · TURALIO
Dosage form; route
CAPSULE;ORAL
Strength
EQ 125MG BASE
Approval date as listed
14 Oct 2022
Type as listed
RX
Applicant as listed
DAIICHI SANKYO 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.

12 entries from 24 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 8,404,700, substance patent
patent.txt lines 13,195, 13,207
Expiry as listed
21 Nov 2027
Rule
R1
Flags
substance
Product numbers
001, 002
US 8,722,702, substance patent
patent.txt lines 13,197, 13,209
Expiry as listed
21 Nov 2027
Rule
R1
Flags
substance
Product numbers
001, 002
US 9,169,250, substance patent
patent.txt lines 13,198, 13,210
Expiry as listed
21 Nov 2027
Rule
R1
Flags
substance
Product numbers
001, 002
US 8,461,169, use patent
patent.txt lines 13,196, 13,208
Expiry as listed
19 Apr 2028
Rule
R1
Flags
use code U-2606
Product numbers
001, 002
US 7,893,075, substance patent
patent.txt lines 13,194, 13,206
Expiry as listed
4 May 2033
Rule
R1
Flags
substance
Product numbers
001, 002
US 9,358,235, use patent
patent.txt lines 13,199, 13,211
Expiry as listed
8 Jun 2033
Rule
R1
Flags
use code U-2606
Product numbers
001, 002
US 10,189,833, use patent
patent.txt lines 13,189, 13,201
Expiry as listed
5 May 2036
Rule
R1
Flags
use code U-2606
Product numbers
001, 002
US 10,730,876, substance patent
patent.txt lines 13,191, 13,203
Expiry as listed
5 May 2036
Rule
R1
Flags
substance
Product numbers
001, 002
US 9,802,932, substance patent
patent.txt lines 13,200, 13,212
Expiry as listed
5 May 2036
Rule
R1
Flags
substance
Product numbers
001, 002
US 10,435,404, product patent
patent.txt lines 13,190, 13,202
Expiry as listed
24 Jul 2038
Rule
R1
Flags
product
Product numbers
001, 002
US 10,941,142, product patent
patent.txt lines 13,192, 13,204
Expiry as listed
24 Jul 2038
Rule
R1
Flags
product
Product numbers
001, 002
US 10,961,240, use patent
patent.txt lines 13,193, 13,205
Expiry as listed
24 Jul 2038
Rule
R1
Flags
use code U-2606
Product numbers
001, 002

Listed exclusivities

Each exclusivity FDA lists for NDA 211810, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

ODE* exclusivity
exclusivity.txt line 1,002
Date
2 Aug 2026
Rule
R3
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
002
ODE-250 exclusivity
exclusivity.txt line 1,001
Date
2 Aug 2026
Rule
R3
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001

Paragraph IV list rows giving NDA 211810

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 211810, each cell as listed.

Rows with no NDA number this page can match are kept apart on the list page; some may concern this product.

No row of the Paragraph IV list captured on 17 October 2026 gives NDA 211810 in its RLD/NDA cell. This does not mean no certification was submitted or that no application challenges a patent listed here.

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