FDA Orange Book
Is there a generic for Incruse Ellipta?
Incruse Ellipta contains umeclidinium bromide. 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 Incruse Ellipta (umeclidinium bromide). The Orange Book shows its last listed patent expires December 18, 2027.
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Incruse Ellipta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, inhalation | EQ 0.0625MG BASE/INH | Marketed (Rx) | None | 0 | None |
NDA 205382, 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.
Incruse Ellipta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7488827 | December 18, 2027 | Drug substance, Drug product | None | 205382 |
Incruse Ellipta NDC codes
Questions
Is there a generic for Incruse Ellipta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Incruse Ellipta (umeclidinium bromide). The Orange Book shows its last listed patent expires December 18, 2027.
What is the generic name for Incruse Ellipta?
The active ingredient in Incruse Ellipta is umeclidinium bromide, per the FDA Orange Book.
When does the Incruse Ellipta patent expire?
The last patent listed for Incruse Ellipta in the Orange Book expires December 18, 2027. 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.