Drybench Patent.

NITRIC OXIDE, NDA 020845

The patents and exclusivities FDA's Orange Book lists for NDA 020845 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 NITRIC OXIDE in the molecule app

Listed protection

Listed dates run from 30 Jun 2029 to 3 Nov 2036, each by its own rule; no one date stands for this product.

Earliest listed date: 30 Jun 2029US 11,931,377, substance and product and use patentRule R1 · Products 003, 004 · patent.txt lines 217, 248
Latest listed date: 3 Nov 2036US 9,770,570 with pediatric exclusivity, as listedRule R2 · Product 003 · patent.txt line 246
Latest substance patent: 30 Dec 2029US 11,931,377 with pediatric exclusivity, as listedRule R2 · Product 003 · patent.txt line 216
Latest listed patent: 3 Nov 2036US 9,770,570 with pediatric exclusivity, as listedRule R2 · Product 003 · patent.txt line 246
Latest exclusivity: None listed

25 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 020845, as listed. The sections below name products by these numbers.

Product 002 · INOMAX
Dosage form; route
GAS;INHALATION
Strength
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval date as listed
23 Dec 1999
Type as listed
DISCN
Applicant as listed
MALLINCKRODT PHARMACEUTICALS IRELAND LTD
Product 003 · INOMAX
Dosage form; route
GAS;INHALATION
Strength
800PPM
Approval date as listed
23 Dec 1999
Type as listed
RX
Applicant as listed
MALLINCKRODT PHARMACEUTICALS IRELAND LTD
Product 004 · INOMAX
Dosage form; route
GAS;INHALATION
Strength
4880PPM
Approval date as listed
17 Jan 2023
Type as listed
RX
Applicant as listed
MALLINCKRODT PHARMACEUTICALS IRELAND LTD

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.

32 entries from 53 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 11,931,377, substance and product and use patent
patent.txt lines 217, 248
Expiry as listed
30 Jun 2029
Rule
R1
Flags
substance · product · use code U-3903
Product numbers
003, 004
US 8,282,966, use patent
patent.txt lines 197, 219
Expiry as listed
30 Jun 2029
Rule
R1
Flags
use code U-1286
Product numbers
002, 003
US 8,293,284, use patent
patent.txt lines 201, 223
Expiry as listed
30 Jun 2029
Rule
R1
Flags
use code U-1286
Product numbers
002, 003
US 8,431,163, use patent
patent.txt lines 203, 225
Expiry as listed
30 Jun 2029
Rule
R1
Flags
use code U-1286
Product numbers
002, 003
US 8,795,741, use patent
patent.txt lines 213, 235
Expiry as listed
30 Jun 2029
Rule
R1
Flags
use code U-1286
Product numbers
002, 003
US 8,846,112, use patent
patent.txt lines 215, 237
Expiry as listed
30 Jun 2029
Rule
R1
Flags
use code U-1286
Product numbers
002, 003
US 11,931,377 with pediatric exclusivity, as listed
patent.txt line 216
Expiry as listed
30 Dec 2029
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
003
US 8,282,966 with pediatric exclusivity, as listed
patent.txt lines 196, 218
Expiry as listed
30 Dec 2029
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
US 8,293,284 with pediatric exclusivity, as listed
patent.txt lines 200, 222
Expiry as listed
30 Dec 2029
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
US 8,431,163 with pediatric exclusivity, as listed
patent.txt lines 202, 224
Expiry as listed
30 Dec 2029
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
US 8,795,741 with pediatric exclusivity, as listed
patent.txt lines 212, 234
Expiry as listed
30 Dec 2029
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
US 8,846,112 with pediatric exclusivity, as listed
patent.txt lines 214, 236
Expiry as listed
30 Dec 2029
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
US 8,291,904, product and use patent
patent.txt lines 199, 221
Expiry as listed
6 Jan 2031
Rule
R1
Flags
product · use code U-1226
Product numbers
002, 003
US 8,573,209, product patent
patent.txt lines 205, 227
Expiry as listed
6 Jan 2031
Rule
R1
Flags
product
Product numbers
002, 003
US 8,573,210, product and use patent
patent.txt lines 207, 229
Expiry as listed
6 Jan 2031
Rule
R1
Flags
product · use code U-1453
Product numbers
002, 003
US 8,776,794, product and use patent
patent.txt lines 209, 231
Expiry as listed
6 Jan 2031
Rule
R1
Flags
product · use code U-1226
Product numbers
002, 003
US 8,776,795, product and use patent
patent.txt lines 211, 233
Expiry as listed
6 Jan 2031
Rule
R1
Flags
product · use code U-1226
Product numbers
002, 003
US 9,265,911, product and use patent
patent.txt line 239
Expiry as listed
6 Jan 2031
Rule
R1
Flags
product · use code U-1824
Product numbers
003
US 9,295,802, product and use patent
patent.txt line 243
Expiry as listed
6 Jan 2031
Rule
R1
Flags
product · use code U-1226
Product numbers
003
US 9,408,993, product and use patent
patent.txt line 245
Expiry as listed
6 Jan 2031
Rule
R1
Flags
product · use code U-1824
Product numbers
003
US 8,291,904 with pediatric exclusivity, as listed
patent.txt lines 198, 220
Expiry as listed
6 Jul 2031
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
US 8,573,209 with pediatric exclusivity, as listed
patent.txt lines 204, 226
Expiry as listed
6 Jul 2031
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
US 8,573,210 with pediatric exclusivity, as listed
patent.txt lines 206, 228
Expiry as listed
6 Jul 2031
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
US 8,776,794 with pediatric exclusivity, as listed
patent.txt lines 208, 230
Expiry as listed
6 Jul 2031
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
US 8,776,795 with pediatric exclusivity, as listed
patent.txt lines 210, 232
Expiry as listed
6 Jul 2031
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
US 9,265,911 with pediatric exclusivity, as listed
patent.txt line 238
Expiry as listed
6 Jul 2031
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
003
US 9,295,802 with pediatric exclusivity, as listed
patent.txt line 242
Expiry as listed
6 Jul 2031
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
003
US 9,408,993 with pediatric exclusivity, as listed
patent.txt line 244
Expiry as listed
6 Jul 2031
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
003
US 9,279,794, product and use patent
patent.txt line 241
Expiry as listed
19 Feb 2035
Rule
R1
Flags
product · use code U-1823
Product numbers
003
US 9,279,794 with pediatric exclusivity, as listed
patent.txt line 240
Expiry as listed
19 Aug 2035
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
003
US 9,770,570, use patent
patent.txt line 247
Expiry as listed
3 May 2036
Rule
R1
Flags
use code U-2148
Product numbers
003
US 9,770,570 with pediatric exclusivity, as listed
patent.txt line 246
Expiry as listed
3 Nov 2036
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
003

Listed exclusivities

Each exclusivity FDA lists for NDA 020845, 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 020845.

Paragraph IV list rows giving NDA 020845

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 020845, 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 020845

Nitric Oxide · for Inhalation · 100 ppm and 800 ppm
RLD/NDA as listed: INOmax 20845
First PIV submission
20 May 2014
ANDAs
1
180-day status
Deferred
Decision posted
19 Nov 2019
First applicant approval
2 Oct 2018
First marketing
1 Apr 2019
Last qualifying patent expiry (as listed by FDA)
6 Jan 2031

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