FDA Orange Book

Is there a generic for Anoro Ellipta?

Anoro Ellipta contains 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 Anoro Ellipta (umeclidinium bromide and vilanterol trifenatate). The Orange Book shows its last listed patent expires November 29, 2030.

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Anoro Ellipta products in the Orange Book

Anoro Ellipta products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
powder, inhalationEQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHMarketed (Rx)None0None

NDA 203975, 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.

Anoro Ellipta patents

Patents listed for Anoro Ellipta
PatentExpiresCoversUse codeNDA
8511304June 14, 2027Drug productU-1476203975
8511304*PEDDecember 14, 2027Method of useNone203975
7488827December 18, 2027Drug substance, Drug productNone203975
11090294November 29, 2030Method of useU-3203203975
9750726November 29, 2030Drug productNone203975
12396986November 29, 2030Drug productNone203975

Anoro Ellipta NDC codes

Questions

Is there a generic for Anoro Ellipta?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Anoro Ellipta (umeclidinium bromide and vilanterol trifenatate). The Orange Book shows its last listed patent expires November 29, 2030.

What is the generic name for Anoro Ellipta?

The active ingredient in Anoro Ellipta is umeclidinium bromide and vilanterol trifenatate, per the FDA Orange Book.

When does the Anoro Ellipta patent expire?

The last patent listed for Anoro Ellipta in the Orange Book expires November 29, 2030. 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.

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