FDA Orange Book

Is there a generic for Onapgo?

Onapgo contains apomorphine. 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 Onapgo (apomorphine). The Orange Book shows its last listed exclusivity ends February 3, 2028.

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Onapgo products in the Orange Book

Onapgo products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, subcutaneous98MG/20ML (4.9MG/ML)Marketed (Rx)None0None

NDA 214056, held by MDD US OPERATIONS LLC A SUB OF SUPERNUS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Onapgo exclusivity

Exclusivity listed for Onapgo
CodeMeaningExpiresNDA
NPNew productFebruary 3, 2028214056

Onapgo NDC codes

Questions

Is there a generic for Onapgo?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Onapgo (apomorphine). The Orange Book shows its last listed exclusivity ends February 3, 2028.

What is the generic name for Onapgo?

The active ingredient in Onapgo is apomorphine, per the FDA Orange Book.

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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