FDA Orange Book
Is there a generic for Arnuity Ellipta?
Arnuity Ellipta contains fluticasone furoate. 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 Arnuity Ellipta (fluticasone furoate). The Orange Book shows its last listed exclusivity ends March 1, 2026.
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Arnuity Ellipta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, inhalation | 0.05MG/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | 0.1MG/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | 0.2MG/INH | Marketed (Rx) | None | 0 | None |
NDA 205625, held by GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Arnuity Ellipta exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-290 | Miscellaneous | March 1, 2026 | 205625 |
Arnuity Ellipta NDC codes
Questions
Is there a generic for Arnuity Ellipta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Arnuity Ellipta (fluticasone furoate). The Orange Book shows its last listed exclusivity ends March 1, 2026.
What is the generic name for Arnuity Ellipta?
The active ingredient in Arnuity Ellipta is fluticasone furoate, 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.
More on Arnuity Ellipta and Fluticasone Furoate
- What is Arnuity Ellipta used for?FDA label uses
- Is Arnuity Ellipta a controlled substance?Federal schedule
- Corticosteroids listFDA drug class
- Arnuity Ellipta Medicare Part D coverageBy plan and state
- NDC 0173-0874Arnuity Ellipta NDC record
- NDC 0173-0876Arnuity Ellipta NDC record
- NDC 0173-0888Arnuity Ellipta NDC record