tolvaptan · Otsuka · NDA 022275
Samsca
Earliest generic entry, as listed · earliest of 2 marketed strengths
7 Apr 2030
Blocked by patent: US 10905694.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10905694 | drug product · sets the listed date | 7 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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022275 · 001 · RLD | tablet, oral | 15MG | 7 Apr 2030 |
| 022275 · 002 · RLD | tablet, oral | 30MG | 7 Apr 2030 |
| 022275 · 003 · RLD · discontinued | tablet, oral | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 7 Apr 2030 |
Expired or delisted (1)
- US 8501730 · substance · 1 Sep 2026