FDA Orange Book
Is there a generic for Lodoco?
Lodoco contains colchicine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lodoco (colchicine). The Orange Book shows its last listed patent expires May 9, 2034.
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Lodoco products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.5MG | Marketed (Rx) | None | 0 | None |
NDA 215727, held by AGEPHA PHARMA FZ LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lodoco patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12364675 | November 1, 2033 | Method of use | U-3639 | 215727 |
| 12233035 | November 1, 2033 | Method of use | U-4132 | 215727 |
| 11026901 | November 1, 2033 | Method of use | U-3638 | 215727 |
| 11026900 | November 1, 2033 | Method of use | U-3639 | 215727 |
| 11026899 | November 1, 2033 | Method of use | U-3639 | 215727 |
| 10842762 | November 1, 2033 | Method of use | U-3640 | 215727 |
| 10265281 | November 1, 2033 | Method of use | U-3639 | 215727 |
| 10206891 | November 1, 2033 | Method of use | U-3641 | 215727 |
| 9744144 | November 1, 2033 | Method of use | U-3643 | 215727 |
| 11944594 | November 1, 2033 | Method of use | U-3864 | 215727 |
| 12280025 | November 1, 2033 | Method of use | U-4168 | 215727 |
| 11944595 | November 1, 2033 | Method of use | U-3867 | 215727 |
| 11944595 | November 1, 2033 | Method of use | U-3868 | 215727 |
| 10130585 | May 9, 2034 | Method of use | U-3642 | 215727 |
Lodoco NDC codes
Questions
Is there a generic for Lodoco?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lodoco (colchicine). The Orange Book shows its last listed patent expires May 9, 2034.
What is the generic name for Lodoco?
The active ingredient in Lodoco is colchicine, per the FDA Orange Book.
When does the Lodoco patent expire?
The last patent listed for Lodoco in the Orange Book expires May 9, 2034. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.