FDA Orange Book
Is there a generic for Elyxyb?
Elyxyb contains celecoxib. 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 Elyxyb (celecoxib). The Orange Book shows its last listed patent expires May 27, 2036.
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Elyxyb products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 25MG/ML | Marketed (Rx) | None | 0 | None |
NDA 212157, 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.
Elyxyb patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10722456 | May 27, 2036 | Drug product | U-2718 | 212157 |
| 10799517 | May 27, 2036 | Drug product | U-2718 | 212157 |
| 9949990 | May 27, 2036 | Drug product | U-2718 | 212157 |
| 9795620 | May 27, 2036 | Drug product | U-2718 | 212157 |
| 9572819 | May 27, 2036 | Drug product | U-2718 | 212157 |
| 10376527 | May 27, 2036 | Drug product | U-2718 | 212157 |
Elyxyb NDC codes
Questions
Is there a generic for Elyxyb?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Elyxyb (celecoxib). The Orange Book shows its last listed patent expires May 27, 2036.
What is the generic name for Elyxyb?
The active ingredient in Elyxyb is celecoxib, per the FDA Orange Book.
When does the Elyxyb patent expire?
The last patent listed for Elyxyb in the Orange Book expires May 27, 2036. 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.