lactitol · Braintree Labs · NDA 211281
Pizensy
Earliest generic entry, as listed
12 May 2037
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10806743. 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 10806743 | use U-1516 | 12 May 2037 |
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 |
|---|---|---|---|
| 211281 · 001 · RLD · discontinued | for solution, oral | 10GM | 12 May 2037 |