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 · 32 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9770570 | — | 3 Nov 2036 |
| US 9770570 | use U-2148 | 3 May 2036 |
| US 9279794 | — | 19 Aug 2035 |
| US 9279794 | product, use U-1823 | 19 Feb 2035 |
| US 8291904 | — | 6 Jul 2031 |
| US 8573209 | — | 6 Jul 2031 |
| US 8573210 | — | 6 Jul 2031 |
| US 8776794 | — | 6 Jul 2031 |
| US 8776795 | — | 6 Jul 2031 |
| US 9265911 | — | 6 Jul 2031 |
| US 9295802 | — | 6 Jul 2031 |
| US 9408993 | — | 6 Jul 2031 |
| US 8291904 | product, use U-1226 | 6 Jan 2031 |
| US 8573209 | product | 6 Jan 2031 |
| US 8573210 | product, use U-1453 | 6 Jan 2031 |
| US 8776794 | product, use U-1226 | 6 Jan 2031 |
| US 8776795 | product, use U-1226 | 6 Jan 2031 |
| US 9265911 | product, use U-1824 | 6 Jan 2031 |
| US 9295802 | product, use U-1226 | 6 Jan 2031 |
| US 9408993 | product, use U-1824 | 6 Jan 2031 |
| US 11931377 | — | 30 Dec 2029 |
| US 8282966 | — | 30 Dec 2029 |
| US 8293284 | — | 30 Dec 2029 |
| US 8431163 | — | 30 Dec 2029 |
| US 8795741 | — | 30 Dec 2029 |
| US 8846112 | — | 30 Dec 2029 |
| US 11931377 | substance, product, use U-3903 | 30 Jun 2029 |
| US 8282966 | use U-1286 | 30 Jun 2029 |
| US 8293284 | use U-1286 | 30 Jun 2029 |
| US 8431163 | use U-1286 | 30 Jun 2029 |
| US 8795741 | use U-1286 | 30 Jun 2029 |
| US 8846112 | use U-1286 | 30 Jun 2029 |
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 | Listed expiry |
|---|---|---|---|
| 020845 · 002 · RLD · discontinued | gas, inhalation | 100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 6 Jul 2031 |
| 020845 · 003 · RLD | gas, inhalation | 800PPM | 3 Nov 2036 |
| 020845 · 004 · RLD | gas, inhalation | 4880PPM | 30 Jun 2029 |