FDA Orange Book
Generic for Gilenya
Gilenya contains fingolimod. 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 Gilenya is fingolimod. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Gilenya products the Orange Book lists.
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Gilenya products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 0.25MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 0.5MG BASE | Marketed (Rx) | AB | 15 | AB |
NDA 022527, 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 fingolimod
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BIOCON LTD | 207979 | AB (A-rated, therapeutically equivalent) | December 4, 2019 | EQ 0.5MG BASE |
| HETERO LABS LTD UNIT V | 207933 | AB (A-rated, therapeutically equivalent) | May 18, 2020 | EQ 0.5MG BASE |
| GLENMARK PHARMACEUTICALS LTD | 207985 | AB (A-rated, therapeutically equivalent) | June 18, 2020 | EQ 0.5MG BASE |
| TEVA PHARMACEUTICALS USA INC | 208008 | AB (A-rated, therapeutically equivalent) | July 2, 2020 | EQ 0.5MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 207994 | AB (A-rated, therapeutically equivalent) | October 14, 2020 | EQ 0.5MG BASE |
| ACCORD HEALTHCARE INC | 207991 | AB (A-rated, therapeutically equivalent) | October 28, 2020 | EQ 0.5MG BASE |
| APOTEX INC | 207993 | AB (A-rated, therapeutically equivalent) | December 18, 2020 | EQ 0.5MG BASE |
| ALKEM LABORATORIES LTD | 208004 | AB (A-rated, therapeutically equivalent) | December 30, 2020 | EQ 0.5MG BASE |
| DR REDDYS LABORATORIES LTD | 208000 | AB (A-rated, therapeutically equivalent) | March 5, 2021 | EQ 0.5MG BASE |
| HEC PHARM CO LTD | 207939 | AB (A-rated, therapeutically equivalent) | November 10, 2021 | EQ 0.5MG BASE |
| PRINSTON PHARMACEUTICAL INC | 208003 | AB (A-rated, therapeutically equivalent) | September 7, 2022 | EQ 0.5MG BASE |
| BIONPHARMA INC | 210252 | AB (A-rated, therapeutically equivalent) | May 24, 2023 | EQ 0.5MG BASE |
| EZRA VENTURES LLC | 207945 | AB (A-rated, therapeutically equivalent) | December 6, 2023 | EQ 0.5MG BASE |
| AUROBINDO PHARMA LTD | 207983 | AB (A-rated, therapeutically equivalent) | February 28, 2024 | EQ 0.5MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 207974 | AB (A-rated, therapeutically equivalent) | April 24, 2026 | EQ 0.5MG BASE |
Gilenya patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10543179 | December 25, 2027 | Method of use | U-2719 | 022527 |
| 9592208 | March 30, 2032 | Drug product | U-2315 | 022527 |
| 9592208*PED | September 30, 2032 | Method of use | None | 022527 |
Gilenya NDC codes
Questions
Is there a generic for Gilenya?
Yes. The generic name for Gilenya is fingolimod. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Gilenya products the Orange Book lists.
What is the generic name for Gilenya?
The active ingredient in Gilenya is fingolimod, per the FDA Orange Book.
When does the Gilenya patent expire?
The last patent listed for Gilenya in the Orange Book expires September 30, 2032. 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.