leuprolide acetate · Abbvie Endocrine Inc · NDA 019732, 020011, 020517, 020708
Lupron Depot
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 | product, use U-1666 | 5 Feb 2031 |
| US 9617303 | use U-4001 | 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 · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019732 · 001 · RLD | injectable, injection | 7.5MG | open |
| 020011 · 001 · RLD · discontinued | injectable, injection | 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020011 · 002 · RLD | injectable, injection | 3.75MG | open |
| 020517 · 001 · RLD | injectable, injection | 22.5MG | open |
| 020517 · 002 · RLD | injectable, injection | 30MG | open |
| 020517 · 003 · RLD | injectable, injection | 45MG | 5 Feb 2031 |
| 020708 · 001 · RLD | injectable, injection | 11.25MG | open |