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

PatentClaimsExpires
US 10130585use U-36429 May 2034
US 10206891use U-36411 Nov 2033
US 10265281use U-36391 Nov 2033
US 10842762use U-36401 Nov 2033
US 11026899use U-36391 Nov 2033
US 11026900use U-36391 Nov 2033
US 11026901use U-36381 Nov 2033
US 11944594use U-38641 Nov 2033
US 11944595use U-38681 Nov 2033
US 11944595use U-38671 Nov 2033
US 12233035use U-41321 Nov 2033
US 12280025use U-41681 Nov 2033
US 12364675use U-36391 Nov 2033
US 9744144use U-36431 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 · 215727-001

Products covered · 1

NDA · productFormStrengthListed expiry
215727 · 001 · RLDtablet, oral0.5MG9 May 2034