balsalazide disodium · Valeant Pharms Intl · NDA 022205
Giazo
Earliest generic entry, as listed
23 Jun 2031
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8497256. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8497256 | use U-1229 · sets the listed date | 23 Jun 2031 |
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 |
|---|---|---|---|
| 022205 · 001 · RLD · discontinued | tablet, oral | 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 23 Jun 2031 |
Expired or delisted (3)
- US 7452872 · use U-1229 · 24 Aug 2026
- US 7625884 · use U-1229 · 24 Aug 2026
- US 9192616 · use U-1229 · 2 Aug 2026