FDA Orange Book
Is there a generic for Epioxa Hd/epioxa Kit?
Epioxa Hd/epioxa Kit contains riboflavin 5'-phosphate. 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 Epioxa Hd/epioxa Kit (riboflavin 5'-phosphate). The Orange Book shows its last listed exclusivity ends October 17, 2028.
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Epioxa Hd/epioxa Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | EQ 0.239% BASE/ML;EQ 0.177% BASE/ML | Marketed (Rx) | None | 0 | None |
NDA 219910, held by GLAUKOS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Epioxa Hd/epioxa Kit exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | October 17, 2028 | 219910 |
Questions
Is there a generic for Epioxa Hd/epioxa Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Epioxa Hd/epioxa Kit (riboflavin 5'-phosphate). The Orange Book shows its last listed exclusivity ends October 17, 2028.
What is the generic name for Epioxa Hd/epioxa Kit?
The active ingredient in Epioxa Hd/epioxa Kit is riboflavin 5'-phosphate, per the FDA Orange Book.
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.