budesonide · Takeda Pharms Usa · NDA 213976
Eohilia
Earliest generic entry, as listed
10 Jan 2039
Blocked by patent: US 11260064, US 11564934.
Listed patents · 12 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11260064 | drug product · sets the listed date | 10 Jan 2039 |
| US 11564934 | use U-3820 · sets the listed date | 10 Jan 2039 |
| US 8324192 | use U-3820 | 3 Aug 2029 |
| US 9050368 | drug product | 1 Aug 2029 |
| US 10293052 | drug product | 22 Nov 2028 |
| US 11357859 | use U-3820 | 12 Nov 2028 |
| US 11197822 | drug product | 9 Nov 2026 |
| US 11413296 | drug product | 9 Nov 2026 |
| US 8497258 | use U-3820 | 9 Nov 2026 |
| US 8679545 | drug product | 9 Nov 2026 |
| US 8975243 | use U-3820 | 9 Nov 2026 |
| US 9119863 | use U-3820 | 9 Nov 2026 |
Exclusivities · 2 unexpired
| ODE-466 | orphan drug (7 years) | 9 Feb 2031 |
| NP | new product | 9 Feb 2027 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213976 · 001 · RLD | suspension, oral | 2MG/10ML | 10 Jan 2039 |