FDA Orange Book
Generic for Afinitor Disperz
Afinitor Disperz contains everolimus. 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 Afinitor Disperz is everolimus. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Afinitor Disperz products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, for suspension, oral | 2MG | Marketed (Rx) | AB | 4 | AB |
| tablet, for suspension, oral | 3MG | Marketed (Rx) | AB | 4 | AB |
| tablet, for suspension, oral | 5MG | Marketed (Rx) | AB | 4 | AB |
NDA 203985, held by NOVARTIS PHARMACEUTICAL CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic everolimus
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL EU LTD | 218863 | AB (A-rated, therapeutically equivalent) | January 10, 2025 | 2MG, 3MG, 5MG |
| NATCO PHARMA LTD | 217640 | AB (A-rated, therapeutically equivalent) | January 28, 2025 | 2MG, 3MG, 5MG |
| BIOCON PHARMA LTD | 217216 | AB (A-rated, therapeutically equivalent) | January 9, 2026 | 2MG, 3MG, 5MG |
| NOVITIUM PHARMA LLC | 220597 | AB (A-rated, therapeutically equivalent) | September 21, 2026 | 2MG, 3MG, 5MG |
Afinitor Disperz NDC codes
Questions
Is there a generic for Afinitor Disperz?
Yes. The generic name for Afinitor Disperz is everolimus. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Afinitor Disperz?
The active ingredient in Afinitor Disperz is everolimus, 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.