sincalide · Maia Pharms Inc · NDA 210850
Sincalide
Earliest generic entry, as listed
20 Apr 2038
Blocked by patent: US 11110063, US 11318100, US 11737983.
Listed patents · 3 unexpired
9 Orange Book listing rows for 3 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11110063 | drug product, use U-3481, U-3482, U-3483 | 20 Apr 2038 |
| US 11110063 listing row | drug product, use U-3481 · sets the listed date | 20 Apr 2038 |
| US 11110063 listing row | drug product, use U-3482 · sets the listed date | 20 Apr 2038 |
| US 11110063 listing row | drug product, use U-3483 · sets the listed date | 20 Apr 2038 |
| US 11318100 | drug product, use U-3477, U-3478, U-3479, U-3480 | 20 Apr 2038 |
| US 11318100 listing row | drug product, use U-3477 · sets the listed date | 20 Apr 2038 |
| US 11318100 listing row | drug product, use U-3478 · sets the listed date | 20 Apr 2038 |
| US 11318100 listing row | drug product, use U-3479 · sets the listed date | 20 Apr 2038 |
| US 11318100 listing row | drug product, use U-3480 · sets the listed date | 20 Apr 2038 |
| US 11737983 | drug product, use U-3482, U-3689 | 20 Apr 2038 |
| US 11737983 listing row | drug product, use U-3482 · sets the listed date | 20 Apr 2038 |
| US 11737983 listing row | drug product, use U-3689 · sets the listed date | 20 Apr 2038 |
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 |
|---|---|---|---|
| 210850 · 001 · RLD | powder, intravenous | 0.005MG/VIAL | 20 Apr 2038 |