Inomax generics — when can they launch?
Inomax (NITRIC OXIDE) · Vero Biotech Inc · 66 active US patents · 1 expired
Where Inomax sits in the generic timeline
All listed Orange Book patents for Inomax have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Method of Use — 28 patents
- Other — 26 patents
- Formulation — 12 patents
FDA U-codes carved out by Inomax patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-3037 | (no description) |
U-1286 | (no description) |
U-3903 | (no description) |
U-2793 | (no description) |
U-1453 | (no description) |
U-1226 | (no description) |
U-1824 | (no description) |
U-1823 | (no description) |
U-2148 | (no description) |
Sample patent estate
Showing 6 of 66 active US patents. View full estate on the Inomax drug page →
-
This patent protects a nitric oxide delivery system that converts nitrogen dioxide to nitric oxide using a surface-active material and antioxidant.USPTO title: Conversion of nitrogen dioxide (NO2) to nitric oxide (NO)
-
This patent protects a nitric oxide delivery system that converts nitrogen dioxide to nitric oxide using a surface-active material and antioxidant.USPTO title: Kit for the conversion of nitrogen dioxide (NO2) to nitric oxide (NO)
-
This patent protects a nitric oxide delivery system that converts nitrogen dioxide to nitric oxide using a surface-active material coated with an antioxidant.USPTO title: Conversion of nitrogen dioxide (NO2) to nitric oxide (NO)
-
This patent protects a system for converting nitrogen dioxide to nitric oxide using a surface-active material coated with an aqueous solution of ascorbic acid and an absorbent.USPTO title: Conversion of nitrogen dioxide (NO2) to nitric oxide (NO)
-
This patent protects methods of reducing the risk or preventing pulmonary edema in children treated with inhaled nitric oxide.USPTO title: Methods of reducing the risk of occurrence of pulmonary edema in children in need of treatment with inhaled nitric oxide
-
This patent protects methods of reducing the risk or preventing pulmonary edema in term or near-term neonates treated with inhaled nitric oxide.USPTO title: Methods of reducing the risk of occurrence of pulmonary edema in term or near-term neonates in need of treatment with inhaled nitric oxide
Sources
- FDA Orange Book — patents listed against Inomax (NDA filed 1999)
- Inomax drug profile — full patent estate, indications, clinical trials, pricing
- Vero Biotech Inc patent portfolio
- Patent cliff 2026 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
Get generic entry alerts
Free Pharma CI alerts on Inomax — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →