FDA Orange Book
Generic for Apokyn
Apokyn 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
Yes. The generic name for Apokyn is apomorphine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Apokyn products the Orange Book lists.
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Apokyn products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, subcutaneous | 20MG/2ML (10MG/ML) | Discontinued | None | 0 | None |
| injectable, subcutaneous | 30MG/3ML (10MG/ML) | Marketed (Rx) | AP | 1 | AP |
NDA 021264, held by MDD US OPERATIONS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic apomorphine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TP ANDA HOLDINGS LLC | 212025 | AP (A-rated, therapeutically equivalent) | February 23, 2022 | 30MG/3ML (10MG/ML) |
Apokyn NDC codes
Questions
Is there a generic for Apokyn?
Yes. The generic name for Apokyn is apomorphine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Apokyn products the Orange Book lists.
What is the generic name for Apokyn?
The active ingredient in Apokyn 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.