FDA Orange Book
Is there a generic for Trelegy Ellipta?
Trelegy Ellipta contains fluticasone furoate, umeclidinium bromide 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 Trelegy Ellipta (fluticasone furoate, umeclidinium bromide and vilanterol trifenatate). The Orange Book shows its last listed patent expires April 11, 2031.
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Trelegy Ellipta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, inhalation | 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | Marketed (Rx) | None | 0 | None |
| powder, inhalation | 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | Marketed (Rx) | None | 0 | None |
NDA 209482, 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.
Trelegy Ellipta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7488827 | December 18, 2027 | Drug substance, Drug product | None | 209482 |
| 8534281 | March 8, 2030 | Drug product | None | 209482 |
| 8534281*PED | September 8, 2030 | Method of use | None | 209482 |
| 8746242 | October 11, 2030 | Drug product | None | 209482 |
| 11090294 | November 29, 2030 | Method of use | U-3202 | 209482 |
| 9750726 | November 29, 2030 | Drug product | None | 209482 |
| 12396986 | November 29, 2030 | Drug product | None | 209482 |
| 8746242*PED | April 11, 2031 | Method of use | None | 209482 |
Trelegy Ellipta NDC codes
Questions
Is there a generic for Trelegy Ellipta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Trelegy Ellipta (fluticasone furoate, umeclidinium bromide and vilanterol trifenatate). The Orange Book shows its last listed patent expires April 11, 2031.
What is the generic name for Trelegy Ellipta?
The active ingredient in Trelegy Ellipta is fluticasone furoate, umeclidinium bromide and vilanterol trifenatate, per the FDA Orange Book.
When does the Trelegy Ellipta patent expire?
The last patent listed for Trelegy 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.