nitisinone · Swedish Orphan · NDA 021232, 206356
Orfadin
Earliest generic entry, as listed · earliest of 5 marketed strengths
28 Feb 2033
4 of 5 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 9301932.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9301932 | product, use U-1836 | 28 Feb 2033 |
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021232 · 001 · RLD | capsule, oral | 2MG | open |
| 021232 · 002 · RLD | capsule, oral | 5MG | open |
| 021232 · 003 · RLD | capsule, oral | 10MG | open |
| 021232 · 004 · RLD | capsule, oral | 20MG | open |
| 206356 · 001 · RLD | suspension, oral | 4MG/ML | 28 Feb 2033 |