testosterone · Upsher Smith Labs · NDA 204399
Vogelxo
Earliest generic entry, as listed · earliest of 2 marketed strengths
11 Feb 2034
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8785426, US 9295675, US 9662340.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8785426 | drug product, use U-1531 · sets the listed date | 11 Feb 2034 |
| US 9295675 | drug product, use U-1531 · sets the listed date | 11 Feb 2034 |
| US 9662340 | drug product, use U-1531 · sets the listed date | 11 Feb 2034 |
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 |
|---|---|---|---|
| 204399 · 002 | gel, transdermal | 50MG/5GM PACKET | 11 Feb 2034 |
| 204399 · 003 | gel, metered, transdermal | 12.5MG/1.25GM ACTUATION | 11 Feb 2034 |