nitisinone · Cycle · NDA 209449
Nityr
Earliest generic entry, as listed · earliest of 3 marketed strengths
5 Jan 2035
Blocked by patent: US 10328029.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10328029 | product, use U-1836 | 5 Jan 2035 |
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 |
|---|---|---|---|
| 209449 · 001 · RLD | tablet, oral | 2MG | 5 Jan 2035 |
| 209449 · 002 · RLD | tablet, oral | 5MG | 5 Jan 2035 |
| 209449 · 003 · RLD | tablet, oral | 10MG | 5 Jan 2035 |