aprepitant · Heron Theraps Inc · NDA 216457
Aponvie
Blocked by patent: US 10500208, US 10624850, US 10953018, US 11173118, US 11744800, US 11878074, US 12115254, US 12115255, US 12290520, US 9561229, US 9808465, US 9974742, US 9974793, US 9974794.
FDA has approved 1 generic application (ANDA) for Aponvie, though its earliest generic-entry date is 18 Sep 2035 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 14 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10500208 | drug product · sets the listed date | 18 Sep 2035 |
| US 10624850 | use U-3440 · sets the listed date | 18 Sep 2035 |
| US 10953018 | use U-3440 · sets the listed date | 18 Sep 2035 |
| US 11173118 | drug product · sets the listed date | 18 Sep 2035 |
| US 11744800 | drug product, use U-3690 · sets the listed date | 18 Sep 2035 |
| US 11878074 | use U-3787 · sets the listed date | 18 Sep 2035 |
| US 12115254 | drug product · sets the listed date | 18 Sep 2035 |
| US 12115255 | drug product · sets the listed date | 18 Sep 2035 |
| US 12290520 | drug product · sets the listed date | 18 Sep 2035 |
| US 9561229 | drug product, use U-3440 · sets the listed date | 18 Sep 2035 |
| US 9808465 | use U-3440 · sets the listed date | 18 Sep 2035 |
| US 9974742 | drug product · sets the listed date | 18 Sep 2035 |
| US 9974793 | drug product · sets the listed date | 18 Sep 2035 |
| US 9974794 | drug product, use U-3440 · sets the listed date | 18 Sep 2035 |
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
- First generic approved · ANDA 218851, Mylan · 216457-001Approved 5 Mar 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218851, Mylan · 216457-001Approved 5 Mar 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216457 · 001 · RLD | emulsion, intravenous | 32MG/4.4ML (7.2MG/ML) | 18 Sep 2035 |