nitric oxide · Mallinckrodt Ireland · NDA 020845

Inomax

Earliest generic entry, as listed · earliest of 2 marketed strengths

30 Jun 2029

Other strengths are listed to 3 Nov 2036.

Blocked by patent: US 11931377, US 8282966, US 8293284, US 8431163, US 8795741, US 8846112.

Listed patents · 16 unexpired

32 Orange Book listing rows for 16 patents, including 16 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 9770570	use U-2148	3 Nov 2036	2 listing rows
US 9770570 listing row	use U-2148	3 May 2036	listed 25 Oct 2017
US 9770570 listing row	pediatric extension	3 Nov 2036
US 9279794	drug product, use U-1823	19 Aug 2035	2 listing rows
US 9279794 listing row	drug product, use U-1823	19 Feb 2035	listed 18 Mar 2016
US 9279794 listing row	pediatric extension	19 Aug 2035
US 8291904	drug product, use U-1226	6 Jul 2031	2 listing rows
US 8291904 listing row	drug product, use U-1226	6 Jan 2031	2 strengths
US 8291904 listing row	pediatric extension	6 Jul 2031	2 strengths
US 8573209	drug product	6 Jul 2031	2 listing rows
US 8573209 listing row	drug product	6 Jan 2031	2 strengths · listed 4 Dec 2013
US 8573209 listing row	pediatric extension	6 Jul 2031	2 strengths
US 8573210	drug product, use U-1453	6 Jul 2031	2 listing rows
US 8573210 listing row	drug product, use U-1453	6 Jan 2031	2 strengths · listed 4 Dec 2013
US 8573210 listing row	pediatric extension	6 Jul 2031	2 strengths
US 8776794	drug product, use U-1226	6 Jul 2031	2 listing rows
US 8776794 listing row	drug product, use U-1226	6 Jan 2031	2 strengths · listed 23 Jul 2014
US 8776794 listing row	pediatric extension	6 Jul 2031	2 strengths
US 8776795	drug product, use U-1226	6 Jul 2031	2 listing rows
US 8776795 listing row	drug product, use U-1226	6 Jan 2031	2 strengths · listed 23 Jul 2014
US 8776795 listing row	pediatric extension	6 Jul 2031	2 strengths
US 9265911	drug product, use U-1824	6 Jul 2031	2 listing rows
US 9265911 listing row	drug product, use U-1824	6 Jan 2031	listed 18 Mar 2016
US 9265911 listing row	pediatric extension	6 Jul 2031
US 9295802	drug product, use U-1226	6 Jul 2031	2 listing rows
US 9295802 listing row	drug product, use U-1226	6 Jan 2031	listed 6 Apr 2016
US 9295802 listing row	pediatric extension	6 Jul 2031
US 9408993	drug product, use U-1824	6 Jul 2031	2 listing rows
US 9408993 listing row	drug product, use U-1824	6 Jan 2031	listed 17 Aug 2016
US 9408993 listing row	pediatric extension	6 Jul 2031
US 11931377	drug substance, drug product, use U-3903	30 Dec 2029	2 listing rows
US 11931377 listing row	drug substance, drug product, use U-3903 · sets the listed date	30 Jun 2029	2 strengths · listed 6 May 2024
US 11931377 listing row	pediatric extension	30 Dec 2029
US 8282966	use U-1286	30 Dec 2029	2 listing rows
US 8282966 listing row	use U-1286 · sets the listed date	30 Jun 2029	2 strengths · listed 10 Oct 2012
US 8282966 listing row	pediatric extension	30 Dec 2029	2 strengths
US 8293284	use U-1286	30 Dec 2029	2 listing rows
US 8293284 listing row	use U-1286 · sets the listed date	30 Jun 2029	2 strengths
US 8293284 listing row	pediatric extension	30 Dec 2029	2 strengths
US 8431163	use U-1286	30 Dec 2029	2 listing rows
US 8431163 listing row	use U-1286 · sets the listed date	30 Jun 2029	2 strengths · listed 1 May 2013
US 8431163 listing row	pediatric extension	30 Dec 2029	2 strengths
US 8795741	use U-1286	30 Dec 2029	2 listing rows
US 8795741 listing row	use U-1286 · sets the listed date	30 Jun 2029	2 strengths · listed 7 Aug 2014
US 8795741 listing row	pediatric extension	30 Dec 2029	2 strengths
US 8846112	use U-1286	30 Dec 2029	2 listing rows
US 8846112 listing row	use U-1286 · sets the listed date	30 Jun 2029	2 strengths · listed 2 Oct 2014
US 8846112 listing row	pediatric extension	30 Dec 2029	2 strengths

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 · 3

NDA · product	Form	Strength	Approved	Listed expiry
020845 · 002 · RLD · discontinued	gas, inhalation	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	23 Dec 1999	6 Jul 2031
020845 · 003 · RLD	gas, inhalation	800PPM	23 Dec 1999	3 Nov 2036
020845 · 004 · RLD	gas, inhalation	4880PPM	17 Jan 2023	30 Jun 2029