colchicine · Takeda Pharms Usa · NDA 022352
Colcrys
Earliest generic entry, as listed
17 Feb 2029
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7820681, US 7906519, US 7915269, US 8440721, US 8440722. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 17 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7820681 | use U-1020 | 17 Feb 2029 |
| US 7906519 | use U-1116 | 17 Feb 2029 |
| US 7915269 | use U-1007 | 17 Feb 2029 |
| US 8440721 | use U-1007 | 17 Feb 2029 |
| US 8440722 | use U-1020 | 17 Feb 2029 |
| US 7601758 | use U-1007 | 10 Feb 2029 |
| US 7619004 | use U-1020 | 3 Dec 2028 |
| US 7935731 | use U-1116 | 3 Dec 2028 |
| US 7964647 | use U-1007 | 6 Oct 2028 |
| US 7964648 | use U-1161 | 6 Oct 2028 |
| US 7981938 | use U-1166 | 6 Oct 2028 |
| US 8093296 | use U-1007 | 6 Oct 2028 |
| US 8093297 | use U-1161 | 6 Oct 2028 |
| US 8093298 | use U-1116 | 6 Oct 2028 |
| US 8097655 | use U-1020 | 6 Oct 2028 |
| US 8415395 | use U-1007 | 6 Oct 2028 |
| US 8415396 | use U-1007 | 6 Oct 2028 |
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 |
|---|---|---|---|
| 022352 · 001 · RLD · discontinued | tablet, oral | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 17 Feb 2029 |