methotrexate · Shorla · NDA 212479
Jylamvo
Earliest generic entry, as listed
28 Oct 2035
Blocked by patent: US 11129833.
Listed patents · 3 unexpired
7 Orange Book listing rows for 3 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11129833 | drug product · sets the listed date | 28 Oct 2035 |
| US 12605385 | drug product | 25 Oct 2035 |
| US 11771701 | drug product, use U-3700, U-3701, U-3702, U-3703, U-3704 | 29 Oct 2034 |
| US 11771701 listing row | drug product, use U-3700 | 29 Oct 2034 |
| US 11771701 listing row | drug product, use U-3701 | 29 Oct 2034 |
| US 11771701 listing row | drug product, use U-3702 | 29 Oct 2034 |
| US 11771701 listing row | drug product, use U-3703 | 29 Oct 2034 |
| US 11771701 listing row | drug product, use U-3704 | 29 Oct 2034 |
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 |
|---|---|---|---|
| 212479 · 001 · RLD | solution, oral | 2MG/ML | 28 Oct 2035 |