diclofenac · Zyla · NDA 204592
Zorvolex
Earliest generic entry, as listed · earliest of 2 marketed strengths
23 Apr 2030
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8679544, US 8999387, US 9017721, US 9173854, US 9180095, US 9180096, US 9186328.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8679544 | drug product · sets the listed date | 23 Apr 2030 |
| US 8999387 | use U-55 · sets the listed date | 23 Apr 2030 |
| US 9017721 | drug product · sets the listed date | 23 Apr 2030 |
| US 9173854 | drug product · sets the listed date | 23 Apr 2030 |
| US 9180095 | use U-55 · sets the listed date | 23 Apr 2030 |
| US 9180096 | drug product · sets the listed date | 23 Apr 2030 |
| US 9186328 | use U-55 · sets the listed date | 23 Apr 2030 |
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 |
|---|---|---|---|
| 204592 · 001 · RLD · discontinued | capsule, oral | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 23 Apr 2030 |
| 204592 · 002 · RLD · discontinued | capsule, oral | 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 23 Apr 2030 |