leucovorin calcium · Avyxa Holdings · NDA 220406
Vykoura
Earliest generic entry, as listed · earliest of 3 marketed strengths
23 Dec 2044
Blocked by patent: US 12564592.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12564592 | drug product · sets the listed date | 23 Dec 2044 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 220406 · 001 · RLD | solution, intramuscular, intravenous | EQ 50MG BASE/5ML (EQ 10MG BASE/ML) | 23 Dec 2044 |
| 220406 · 002 · RLD | solution, intramuscular, intravenous | EQ 350MG BASE/35ML (EQ 10MG BASE/ML) | 23 Dec 2044 |
| 220406 · 003 · RLD | solution, intramuscular, intravenous | EQ 500MG BASE/50ML (EQ 10MG BASE/ML) | 23 Dec 2044 |