leuprolide acetate · Abbvie Endocrine Inc · NDA 020263
Lupron Depot-Ped Kit
Earliest generic entry, as listed · earliest of 6 marketed strengths
5 Feb 2031
5 of 6 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 8921326.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8921326 | drug product · sets the listed date | 5 Feb 2031 |
| US 9617303 | use U-3611 | 22 Mar 2028 |
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 · 8
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020263 · 002 · RLD | powder, intramuscular | 7.5MG | open |
| 020263 · 003 · RLD · discontinued | powder, intramuscular | 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020263 · 004 · RLD · discontinued | powder, intramuscular | 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020263 · 005 · RLD | powder, intramuscular | 11.25MG | open |
| 020263 · 006 · RLD | powder, intramuscular | 15MG | open |
| 020263 · 007 · RLD | powder, intramuscular | 11.25MG | open |
| 020263 · 008 · RLD | powder, intramuscular | 30MG | open |
| 020263 · 009 · RLD | powder, intramuscular | 45MG | 5 Feb 2031 |
Expired or delisted (1)
- NS · 14 Apr 2026