budesonide · Sun Pharm Inds Inc · NDA 211929
Ortikos
Earliest generic entry, as listed · earliest of 2 marketed strengths
9 Sep 2036
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10172802, US 9707182.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10172802 | use U-2554 | 9 Sep 2036 |
| US 9707182 | product, use U-2554 | 9 Sep 2036 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211929 · 001 · RLD · discontinued | capsule, delayed release, oral | 6MG | 9 Sep 2036 |
| 211929 · 002 · RLD · discontinued | capsule, delayed release, oral | 9MG | 9 Sep 2036 |