colchicine · Agepha Pharma Fz · NDA 215727
Lodoco
Earliest generic entry, as listed
9 May 2034
Blocked by patent: US 10130585. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 14 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10130585 | use U-3642 | 9 May 2034 |
| US 10206891 | use U-3641 | 1 Nov 2033 |
| US 10265281 | use U-3639 | 1 Nov 2033 |
| US 10842762 | use U-3640 | 1 Nov 2033 |
| US 11026899 | use U-3639 | 1 Nov 2033 |
| US 11026900 | use U-3639 | 1 Nov 2033 |
| US 11026901 | use U-3638 | 1 Nov 2033 |
| US 11944594 | use U-3864 | 1 Nov 2033 |
| US 11944595 | use U-3868 | 1 Nov 2033 |
| US 11944595 | use U-3867 | 1 Nov 2033 |
| US 12233035 | use U-4132 | 1 Nov 2033 |
| US 12280025 | use U-4168 | 1 Nov 2033 |
| US 12364675 | use U-3639 | 1 Nov 2033 |
| US 9744144 | use U-3643 | 1 Nov 2033 |
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
- 25 Oct 2026Generic tentatively approved · 215727-00113 Feb 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215727 · 001 · RLD | tablet, oral | 0.5MG | 9 May 2034 |