FDA Orange Book
Is there a generic for Xromi?
Xromi contains hydroxyurea. 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 Xromi (hydroxyurea). The Orange Book shows its last listed patent expires December 23, 2041 and its last listed exclusivity ends April 4, 2031.
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Xromi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 100MG/ML | Marketed (Rx) | None | 0 | None |
NDA 216593, held by NOVA LABORATORIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xromi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12409156 | December 23, 2041 | Drug product | None | 216593 |
Xromi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | April 4, 2027 | 216593 |
| ODE-470 | Orphan drug exclusivity | April 4, 2031 | 216593 |
Xromi NDC codes
Questions
Is there a generic for Xromi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xromi (hydroxyurea). The Orange Book shows its last listed patent expires December 23, 2041 and its last listed exclusivity ends April 4, 2031.
What is the generic name for Xromi?
The active ingredient in Xromi is hydroxyurea, per the FDA Orange Book.
When does the Xromi patent expire?
The last patent listed for Xromi in the Orange Book expires December 23, 2041. 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.