FDA Orange Book
Generic for Myfortic
Myfortic contains mycophenolate. 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 Myfortic is mycophenolate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Myfortic products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, delayed release, oral | EQ 180MG BASE | Marketed (Rx) | AB | 9 | AB |
| tablet, delayed release, oral | EQ 360MG BASE | Marketed (Rx) | AB | 9 | AB |
NDA 050791, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic mycophenolate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 091558 | AB (A-rated, therapeutically equivalent) | August 21, 2012 | EQ 180MG BASE, EQ 360MG BASE |
| ACCORD HEALTHCARE INC | 202555 | AB (A-rated, therapeutically equivalent) | August 23, 2017 | EQ 180MG BASE, EQ 360MG BASE |
| CONCORD BIOTECH LTD | 211173 | AB (A-rated, therapeutically equivalent) | December 13, 2019 | EQ 180MG BASE, EQ 360MG BASE |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 214376 | AB (A-rated, therapeutically equivalent) | February 10, 2021 | EQ 180MG BASE, EQ 360MG BASE |
| ALKEM LABORATORIES LTD | 208315 | AB (A-rated, therapeutically equivalent) | September 23, 2021 | EQ 180MG BASE, EQ 360MG BASE |
| BIOCON PHARMA LTD | 214630 | AB (A-rated, therapeutically equivalent) | November 29, 2021 | EQ 180MG BASE, EQ 360MG BASE |
| BIOCON PHARMA INC | 217031 | AB (A-rated, therapeutically equivalent) | November 29, 2023 | EQ 180MG BASE, EQ 360MG BASE |
| AUROBINDO PHARMA LTD | 218603 | AB (A-rated, therapeutically equivalent) | February 27, 2024 | EQ 180MG BASE, EQ 360MG BASE |
| FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO LTD | 216637 | AB (A-rated, therapeutically equivalent) | May 29, 2024 | EQ 180MG BASE, EQ 360MG BASE |
Myfortic NDC codes
Questions
Is there a generic for Myfortic?
Yes. The generic name for Myfortic is mycophenolate. 9 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 Myfortic?
The active ingredient in Myfortic is mycophenolate, 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.