cupric sulfate; manganese sulfate; selenious acid; zinc sulfate · Am Regent · NDA 209376
Tralement
Earliest generic entry, as listed · earliest of 2 marketed strengths
1 Jul 2041
Blocked by patent: US 11786548, US 11975022, US 11998565, US 12150956, US 12150957.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11786548 | product | 1 Jul 2041 |
| US 11975022 | use U-3899 | 1 Jul 2041 |
| US 11998565 | product | 1 Jul 2041 |
| US 12150956 | use U-3899 | 1 Jul 2041 |
| US 12150957 | use U-3899 | 1 Jul 2041 |
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 |
|---|---|---|---|
| 209376 · 001 · RLD | solution, intravenous | EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML) | 1 Jul 2041 |
| 209376 · 002 · RLD | solution, intravenous | EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML) | 1 Jul 2041 |