Nourianz generics — when can they launch?
Nourianz (ISTRADEFYLLINE) · Kyowa Kirin · 4 active US patents · 0 expired
Where Nourianz sits in the generic timeline
Imminent generic cliff: earliest active US patent for Nourianz expires in 2027 (~1 year from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
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.
- Formulation — 2 patents
- Method of Use — 2 patents
FDA U-codes carved out by Nourianz 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-2623 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Nourianz drug page →
-
This patent protects a method for stabilizing a diarylvinylene compound in a solid formulation.USPTO title: Method of stabilizing diarylvinylene compound
-
This patent protects a method for stabilizing a diarylvinylene compound in a solid formulation.USPTO title: Method of stabilizing diarylvinylene compound
-
This patent protects methods of treating movement disorders, including reducing side effects of Parkinson's disease therapy, by administering adenosine A2A receptor antagonists.USPTO title: Administering adenosine A2A receptor antagonist to reduce or suppress side effects of parkinson's disease therapy
-
This patent protects methods of treating movement disorders, including reducing side effects of Parkinson's disease therapy, by administering adenosine A2A receptor antagonists.USPTO title: Administering adenosine A2A receptor antagonist to reduce or suppress side effects of parkinson's disease therapy
Sources
- FDA Orange Book — patents listed against Nourianz (NDA filed 2019)
- Nourianz drug profile — full patent estate, indications, clinical trials, pricing
- Kyowa Kirin patent portfolio
- Patent cliff 2027 — 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 Nourianz — 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 →