terazosin hydrochloride · Novitium Pharma · NDA 218139
Tezruly
Earliest generic entry, as listed
1 Feb 2041
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 11224572, US 12427108.
Listed patents · 2 unexpired
4 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 11224572 | drug product, use U-3990, U-3991 | 1 Feb 2041 |
| US 11224572 listing row | drug product, use U-3990 · sets the listed date | 1 Feb 2041 |
| US 11224572 listing row | drug product, use U-3991 · sets the listed date | 1 Feb 2041 |
| US 12427108 | drug product, use U-3990, U-3991 | 1 Feb 2041 |
| US 12427108 listing row | drug product, use U-3990 · sets the listed date | 1 Feb 2041 |
| US 12427108 listing row | drug product, use U-3991 · sets the listed date | 1 Feb 2041 |
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 |
|---|---|---|---|
| 218139 · 001 · RLD · discontinued | solution, oral | EQ 1MG BASE/ML | 1 Feb 2041 |