spironolactone · Cmp Dev Llc · NDA 209478
Carospir
Earliest generic entry, as listed
28 Oct 2036
Blocked by patent: US 10493083, US 10624906, US 10660907, US 10888570, US 11389461, US 11395828, US 11491166, US 9757394.
Listed patents · 8 unexpired
10 Orange Book listing rows for 8 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10493083 | drug product · sets the listed date | 28 Oct 2036 |
| US 10624906 | drug product · sets the listed date | 28 Oct 2036 |
| US 10660907 | drug product · sets the listed date | 28 Oct 2036 |
| US 10888570 | drug product · sets the listed date | 28 Oct 2036 |
| US 11389461 | drug product · sets the listed date | 28 Oct 2036 |
| US 11395828 | use U-2109, U-3401, U-3402 | 28 Oct 2036 |
| US 11395828 listing row | use U-2109 · sets the listed date | 28 Oct 2036 |
| US 11395828 listing row | use U-3401 · sets the listed date | 28 Oct 2036 |
| US 11395828 listing row | use U-3402 · sets the listed date | 28 Oct 2036 |
| US 11491166 | drug product · sets the listed date | 28 Oct 2036 |
| US 9757394 | drug product, use U-2109 · sets the listed date | 28 Oct 2036 |
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 |
|---|---|---|---|
| 209478 · 001 · RLD | suspension, oral | 25MG/5ML | 28 Oct 2036 |