testosterone · Acerus · NDA 205488
Natesto
Earliest generic entry, as listed
17 Mar 2034
Blocked by patent: US 11090312, US 11744838. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
3 Orange Book listing rows for 2 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11090312 | use U-1616 · sets the listed date | 17 Mar 2034 |
| US 11744838 | use U-4366, U-4367 | 17 Mar 2034 |
| US 11744838 listing row | use U-4366 · sets the listed date | 17 Mar 2034 |
| US 11744838 listing row | use U-4367 · sets the listed date | 17 Mar 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205488 · 001 · RLD | gel, metered, nasal | 5.5MG/0.122GM ACTUATION | 17 Mar 2034 |