colchicine · Hikma · NDA 204820
Mitigare
Blocked by patent: US 8927607, US 9399036, US 9555029, US 9675613, US 9789108. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
FDA has approved 1 generic application (ANDA) for Mitigare, though its earliest generic-entry date is 22 Aug 2033 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8927607 | use U-1020 | 22 Aug 2033 |
| US 9399036 | use U-1020 | 22 Aug 2033 |
| US 9555029 | use U-1020 | 22 Aug 2033 |
| US 9675613 | use U-1020 | 22 Aug 2033 |
| US 9789108 | use U-1020 | 22 Aug 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 approved · 204820-00117 Feb 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204820 · 001 · RLD | capsule, oral | 0.6MG | 22 Aug 2033 |