Drybench Patent.

DEXMEDETOMIDINE HYDROCHLORIDE, NDA 021038

The patents and exclusivities FDA's Orange Book lists for NDA 021038 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 DEXMEDETOMIDINE HYDROCHLORIDE in the molecule app

Listed protection

Listed dates run from 4 Jan 2032 to 4 Jul 2032, each by its own rule; no one date stands for this product.

Earliest listed date: 4 Jan 2032US 10,016,396, product patentRule R1 · Products 002, 003 · patent.txt lines 407, 420
Latest listed date: 4 Jul 2032US 9,616,049 with pediatric exclusivity, as listedRule R2 · Products 002, 003, 004 · patent.txt lines 418, 431, 443
Latest substance patent: None listed
Latest listed patent: 4 Jul 2032US 9,616,049 with pediatric exclusivity, as listedRule R2 · Products 002, 003, 004 · patent.txt lines 418, 431, 443
Latest exclusivity: None listed

3 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 021038, as listed. The sections below name products by these numbers.

Product 001 · PRECEDEX
Dosage form; route
INJECTABLE;INJECTION
Strength
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval date as listed
17 Dec 1999
Type as listed
RX
Applicant as listed
HOSPIRA INC
Product 002 · PRECEDEX
Dosage form; route
INJECTABLE;INJECTION
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval date as listed
13 Mar 2013
Type as listed
RX
Applicant as listed
HOSPIRA INC
Product 003 · PRECEDEX
Dosage form; route
INJECTABLE;INJECTION
Strength
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval date as listed
13 Mar 2013
Type as listed
RX
Applicant as listed
HOSPIRA INC
Product 004 · PRECEDEX
Dosage form; route
INJECTABLE;INJECTION
Strength
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
Approval date as listed
14 Nov 2014
Type as listed
RX
Applicant as listed
HOSPIRA INC
Product 005 · PRECEDEX
Dosage form; route
INJECTABLE;INJECTION
Strength
EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)
Approval date as listed
31 Jan 2020
Type as listed
RX
Applicant as listed
HOSPIRA 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.

13 entries from 38 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 10,016,396, product patent
patent.txt lines 407, 420
Expiry as listed
4 Jan 2032
Rule
R1
Flags
product
Product numbers
002, 003
US 8,242,158, product patent
patent.txt lines 409, 422, 434
Expiry as listed
4 Jan 2032
Rule
R1
Flags
product
Product numbers
002, 003, 004
US 8,338,470, product patent
patent.txt lines 411, 424, 436
Expiry as listed
4 Jan 2032
Rule
R1
Flags
product
Product numbers
002, 003, 004
US 8,455,527, use patent
patent.txt lines 413, 426, 438
Expiry as listed
4 Jan 2032
Rule
R1
Flags
use code U-421
Product numbers
002, 003, 004
US 8,648,106, product patent
patent.txt lines 415, 428, 440
Expiry as listed
4 Jan 2032
Rule
R1
Flags
product
Product numbers
002, 003, 004
US 9,320,712, product patent
patent.txt lines 417, 430, 442
Expiry as listed
4 Jan 2032
Rule
R1
Flags
product
Product numbers
002, 003, 004
US 9,616,049, product patent
patent.txt lines 419, 432, 444
Expiry as listed
4 Jan 2032
Rule
R1
Flags
product
Product numbers
002, 003, 004
US 8,242,158 with pediatric exclusivity, as listed
patent.txt lines 408, 421, 433
Expiry as listed
4 Jul 2032
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
002, 003, 004
US 8,338,470 with pediatric exclusivity, as listed
patent.txt lines 410, 423, 435
Expiry as listed
4 Jul 2032
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
002, 003, 004
US 8,455,527 with pediatric exclusivity, as listed
patent.txt lines 412, 425, 437
Expiry as listed
4 Jul 2032
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002, 003, 004
US 8,648,106 with pediatric exclusivity, as listed
patent.txt lines 414, 427, 439
Expiry as listed
4 Jul 2032
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
002, 003, 004
US 9,320,712 with pediatric exclusivity, as listed
patent.txt lines 416, 429, 441
Expiry as listed
4 Jul 2032
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
002, 003, 004
US 9,616,049 with pediatric exclusivity, as listed
patent.txt lines 418, 431, 443
Expiry as listed
4 Jul 2032
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
002, 003, 004

Listed exclusivities

Each exclusivity FDA lists for NDA 021038, 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 021038.

Paragraph IV list rows giving NDA 021038

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 021038, 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 021038

Dexmedetomidine · Injection · 100 mcg/mL
RLD/NDA as listed: Precedex 21038
First PIV submission
8 Apr 2009
ANDAs
1
180-day status
Eligible
Decision posted
7 Apr 2020
First applicant approval
14 Jun 2016
First marketing
22 Sep 2014
Last qualifying patent expiry (as listed by FDA)
31 Mar 2019
Dexmedetomidine · Injection · 4 mcg/mL, 20 mL vials
RLD/NDA as listed: Precedex 21038
First PIV submission
30 Sep 2015
ANDAs
1
180-day status
Eligible
Decision posted
2 Jul 2019
First applicant approval
29 Nov 2018
First marketing
3 Jun 2019
Last qualifying patent expiry (as listed by FDA)
4 Jan 2032
Dexmedetomidine · Injection · 4 mcg/mL, 50 mL and 100 mL vials
RLD/NDA as listed: Precedex 21038
First PIV submission
26 Dec 2013
ANDAs
1
180-day status
Extinguished
Decision posted
13 Aug 2019
First applicant approval
30 Jan 2020
First marketing
blank
Last qualifying patent expiry (as listed by FDA)
4 Jan 2032

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