methotrexate sodium · Azurity · NDA 208400
Xatmep
Earliest generic entry, as listed
2 Jan 2033
Blocked by patent: US 10231927, US 10610485, US 11116724, US 11969503, US 12396947, US 9259427, US 9855215.
Listed patents · 7 unexpired
9 Orange Book listing rows for 7 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10231927 | use U-1349, U-1699 | 2 Jan 2033 |
| US 10231927 listing row | use U-1349 · sets the listed date | 2 Jan 2033 |
| US 10231927 listing row | use U-1699 · sets the listed date | 2 Jan 2033 |
| US 10610485 | drug product · sets the listed date | 2 Jan 2033 |
| US 11116724 | use U-1349, U-1699 | 2 Jan 2033 |
| US 11116724 listing row | use U-1349 · sets the listed date | 2 Jan 2033 |
| US 11116724 listing row | use U-1699 · sets the listed date | 2 Jan 2033 |
| US 11969503 | drug product · sets the listed date | 2 Jan 2033 |
| US 12396947 | drug product · sets the listed date | 2 Jan 2033 |
| US 9259427 | drug product · sets the listed date | 2 Jan 2033 |
| US 9855215 | drug product · sets the listed date | 2 Jan 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208400 · 001 · RLD | solution, oral | EQ 2.5MG BASE/ML | 2 Jan 2033 |