FDA Orange Book
Generic for Sandimmune
Sandimmune contains cyclosporine. 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 Sandimmune is cyclosporine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AP.
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Sandimmune products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | AB2 | 9 | AB1, AB2 |
| capsule, oral | 25MG | Marketed (Rx) | AB2 | 9 | AB1, AB2 |
| capsule, oral | 50MG | Marketed (Rx) | BX | 4 | AB1 |
| injectable, injection | 50MG/ML | Marketed (Rx) | AP | 1 | AP |
| solution, oral | 100MG/ML | Marketed (Rx) | None | 1 | AB1 |
NDA 050625, 050573, 050574, 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 cyclosporine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 065004 | AP (A-rated, therapeutically equivalent) | October 29, 1999 | 50MG/ML |
| SANDOZ INC | 065017 | AB1 (A-rated, therapeutically equivalent) | January 13, 2000 | 100MG, 25MG |
| ABBVIE INC | 065003 | AB1 (A-rated, therapeutically equivalent) | May 12, 2000 | 100MG, 25MG |
| DR REDDYS LABORATORIES SA | 065044 | AB1 (A-rated, therapeutically equivalent) | December 20, 2000 | 100MG, 25MG |
| APOTEX INC | 065040 | AB2 (A-rated, therapeutically equivalent) | May 9, 2002 | 100MG, 25MG |
| IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 065078 | AB1 (A-rated, therapeutically equivalent) | March 25, 2005 | 100MG/ML |
| IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 065110 | AB1 (A-rated, therapeutically equivalent) | March 29, 2005 | 100MG, 25MG, 50MG |
| APOTEX INC | 210721 | AB1 (A-rated, therapeutically equivalent) | July 10, 2019 | 100MG, 25MG, 50MG |
| ONESOURCE SOFTGELS PTE LTD | 216046 | AB1 (A-rated, therapeutically equivalent) | August 2, 2022 | 100MG, 25MG, 50MG |
| QILU PHARMACEUTICAL CO LTD | 219049 | AB1 (A-rated, therapeutically equivalent) | September 15, 2025 | 100MG, 25MG |
| AUROBINDO PHARMA LTD | 219652 | AB1 (A-rated, therapeutically equivalent) | September 17, 2026 | 100MG, 25MG, 50MG |
Sandimmune NDC codes
Questions
Is there a generic for Sandimmune?
Yes. The generic name for Sandimmune is cyclosporine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AP.
What is the generic name for Sandimmune?
The active ingredient in Sandimmune is cyclosporine, 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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