FDA Orange Book
Is there a generic for Xhance?
Xhance contains fluticasone propionate. 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 Xhance (fluticasone propionate). The Orange Book shows its last listed patent expires February 23, 2036 and its last listed exclusivity ends March 15, 2027.
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Xhance products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, nasal | 0.093MG/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 209022, held by PARATEK PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xhance patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12083270 | April 4, 2031 | Method of use | U-2133 | 209022 |
| 11554229 | February 23, 2036 | Method of use | U-2133 | 209022 |
| 12616806 | February 23, 2036 | Method of use | U-4524 | 209022 |
| 12616806 | February 23, 2036 | Method of use | U-4525 | 209022 |
Xhance exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-940 | New indication | March 15, 2027 | 209022 |
Xhance NDC codes
Questions
Is there a generic for Xhance?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xhance (fluticasone propionate). The Orange Book shows its last listed patent expires February 23, 2036 and its last listed exclusivity ends March 15, 2027.
What is the generic name for Xhance?
The active ingredient in Xhance is fluticasone propionate, per the FDA Orange Book.
When does the Xhance patent expire?
The last patent listed for Xhance in the Orange Book expires February 23, 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.
More on Xhance and Fluticasone Propionate
- What is Xhance used for?FDA label uses
- Is Xhance a controlled substance?Federal schedule
- What is Fluticasone Propionate used for?FDA label uses
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