FDA Orange Book
Is there a generic for Gloperba?
Gloperba 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 Gloperba (colchicine). The Orange Book shows its last listed patent expires December 20, 2037.
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Gloperba products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 0.6MG/5ML | Marketed (Rx) | None | 0 | None |
NDA 210942, held by SCILEX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Gloperba patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12274751 | November 22, 2036 | Method of use | U-2814 | 210942 |
| 12514819 | November 22, 2036 | Method of use | U-2814 | 210942 |
| 10383820 | November 22, 2036 | Drug product | U-2814 | 210942 |
| 10383821 | November 22, 2036 | Drug product | None | 210942 |
| 9907751 | November 22, 2036 | Drug product | None | 210942 |
| 10226423 | December 20, 2037 | Drug product | None | 210942 |
Gloperba NDC codes
Questions
Is there a generic for Gloperba?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gloperba (colchicine). The Orange Book shows its last listed patent expires December 20, 2037.
What is the generic name for Gloperba?
The active ingredient in Gloperba is colchicine, per the FDA Orange Book.
When does the Gloperba patent expire?
The last patent listed for Gloperba in the Orange Book expires December 20, 2037. 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.