leuprolide acetate · Tolmar · NDA 021343, 021379, 021488, 021731
Eligard Kit
Earliest generic entry, as listed · earliest of 4 marketed strengths
22 Dec 2041
Blocked by patent: US 11771841, US 11931559, US 12397120.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11771841 | drug substance, drug product · sets the listed date | 22 Dec 2041 |
| US 11931559 | drug substance · sets the listed date | 22 Dec 2041 |
| US 12397120 | use U-4001 · sets the listed date | 22 Dec 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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021343 · 001 · RLD | powder, subcutaneous | 7.5MG | 22 Dec 2041 |
| 021379 · 001 · RLD | powder, subcutaneous | 22.5MG | 22 Dec 2041 |
| 021488 · 001 · RLD | powder, subcutaneous | 30MG | 22 Dec 2041 |
| 021731 · 001 · RLD | powder, subcutaneous | 45MG | 22 Dec 2041 |