FDA Orange Book

Is there a generic for Inbrija?

Inbrija contains levodopa. 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 Inbrija (levodopa). The Orange Book shows its last listed patent expires October 21, 2033.

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Inbrija products in the Orange Book

Inbrija products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
powder, inhalation42MGMarketed (Rx)None0None

NDA 209184, held by MERZ PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Inbrija patents

Patents listed for Inbrija
PatentExpiresCoversUse codeNDA
RE43711February 3, 2029Method of useU-2484209184
8685442November 16, 2032Drug productNone209184
8945612November 16, 2032Drug productNone209184
8545878November 16, 2032Drug productNone209184
9393210November 16, 2032Drug productNone209184
12458615October 21, 2033Method of useU-2484209184

Inbrija NDC codes

Questions

Is there a generic for Inbrija?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Inbrija (levodopa). The Orange Book shows its last listed patent expires October 21, 2033.

What is the generic name for Inbrija?

The active ingredient in Inbrija is levodopa, per the FDA Orange Book.

When does the Inbrija patent expire?

The last patent listed for Inbrija in the Orange Book expires October 21, 2033. 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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