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.

Run it in Rivvi

Map Xhance and your other top fills to their generics

Every strength in RxNorm, with brands that have no generic flagged.

Build the map

Free to start. Opens Rivvi, the AI workspace for healthcare teams.

Xhance products in the Orange Book

Xhance products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
spray, metered, nasal0.093MG/SPRAYMarketed (Rx)None0None

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

Patents listed for Xhance
PatentExpiresCoversUse codeNDA
12083270April 4, 2031Method of useU-2133209022
11554229February 23, 2036Method of useU-2133209022
12616806February 23, 2036Method of useU-4524209022
12616806February 23, 2036Method of useU-4525209022

Xhance exclusivity

Exclusivity listed for Xhance
CodeMeaningExpiresNDA
I-940New indicationMarch 15, 2027209022

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

Try it on your own data today.

Free to start. Most teams are using it the same day.