FDA Orange Book
Is there a generic for Breo Ellipta?
Breo Ellipta contains fluticasone furoate and vilanterol trifenatate. 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 Breo Ellipta (fluticasone furoate and vilanterol trifenatate). The Orange Book shows its last listed patent expires April 11, 2031 and its last listed exclusivity ends November 13, 2026.
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Breo Ellipta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, inhalation | 0.05MG/INH;EQ 0.025MG BASE/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | 0.1MG/INH;EQ 0.025MG BASE/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | 0.2MG/INH;EQ 0.025MG BASE/INH | Marketed (Rx) | None | 0 | None |
NDA 204275, held by GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Breo Ellipta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8511304 | June 14, 2027 | Drug product | U-3623 | 204275 |
| 8511304 | June 14, 2027 | Drug product | U-1691 | 204275 |
| 8511304 | June 14, 2027 | Drug product | U-1424 | 204275 |
| 8511304*PED | December 14, 2027 | Method of use | None | 204275 |
| 11116721 | February 26, 2029 | Drug product | U-3623 | 204275 |
| 11116721 | February 26, 2029 | Drug product | U-1401 | 204275 |
| 11116721 | February 26, 2029 | Drug product | U-1691 | 204275 |
| 11116721*PED | August 26, 2029 | Method of use | None | 204275 |
| 8534281 | March 8, 2030 | Drug product | None | 204275 |
| 8534281*PED | September 8, 2030 | Method of use | None | 204275 |
| 8746242 | October 11, 2030 | Drug product | None | 204275 |
| 8746242*PED | April 11, 2031 | Method of use | None | 204275 |
Breo Ellipta exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NS | New strength | May 13, 2026 | 204275 |
| NPP | New patient population | May 13, 2026 | 204275 |
| PED | Pediatric exclusivity | November 13, 2026 | 204275 |
Breo Ellipta NDC codes
Questions
Is there a generic for Breo Ellipta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Breo Ellipta (fluticasone furoate and vilanterol trifenatate). The Orange Book shows its last listed patent expires April 11, 2031 and its last listed exclusivity ends November 13, 2026.
What is the generic name for Breo Ellipta?
The active ingredient in Breo Ellipta is fluticasone furoate and vilanterol trifenatate, per the FDA Orange Book.
When does the Breo Ellipta patent expire?
The last patent listed for Breo Ellipta in the Orange Book expires April 11, 2031. 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.