FDA Orange Book
Is there a generic for Xenoview?
Xenoview contains xenon xe-129 hyperpolarized. 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 Xenoview (xenon xe-129 hyperpolarized). The Orange Book shows its last listed patent expires December 29, 2035 and its last listed exclusivity ends December 23, 2027.
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Xenoview products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gas, inhalation | N/A | Marketed (Rx) | None | 0 | None |
NDA 214375, held by POLAREAN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xenoview patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10583205 | February 20, 2035 | Drug product | None | 214375 |
| 11052161 | December 29, 2035 | Drug product | None | 214375 |
Xenoview exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 23, 2027 | 214375 |
Xenoview NDC codes
Questions
Is there a generic for Xenoview?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xenoview (xenon xe-129 hyperpolarized). The Orange Book shows its last listed patent expires December 29, 2035 and its last listed exclusivity ends December 23, 2027.
What is the generic name for Xenoview?
The active ingredient in Xenoview is xenon xe-129 hyperpolarized, per the FDA Orange Book.
When does the Xenoview patent expire?
The last patent listed for Xenoview in the Orange Book expires December 29, 2035. 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.