FDA Orange Book
Generic for Restasis MultiDose
Restasis MultiDose 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 Restasis MultiDose is cyclosporine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Restasis MultiDose products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| emulsion, ophthalmic | 0.05% | Marketed (Rx) | None | 6 | AB |
NDA 050790, held by ABBVIE INC. 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 |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 205894 | AB (A-rated, therapeutically equivalent) | February 2, 2022 | 0.05% |
| TEVA PHARMACEUTICALS USA INC | 203880 | AB (A-rated, therapeutically equivalent) | December 14, 2023 | 0.05% |
| DEVA HOLDING AS | 209811 | AB (A-rated, therapeutically equivalent) | May 21, 2024 | 0.05% |
| SAPTALIS PHARMACEUTICALS LLC | 211943 | AB (A-rated, therapeutically equivalent) | July 5, 2024 | 0.05% |
| TWI PHARMACEUTICALS INC | 209064 | AB (A-rated, therapeutically equivalent) | January 21, 2026 | 0.05% |
| JIANGSU ANBISON PHARMACEUTICAL CO LTD | 219288 | AB (A-rated, therapeutically equivalent) | June 1, 2026 | 0.05% |
Restasis MultiDose patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8292129 | February 25, 2031 | Drug product | None | 050790 |
| 8561859 | April 16, 2032 | Drug product | None | 050790 |
| 9676525 | February 7, 2034 | Drug product | None | 050790 |
| 9669974 | May 11, 2034 | Drug product | None | 050790 |
Restasis MultiDose NDC codes
Questions
Is there a generic for Restasis MultiDose?
Yes. The generic name for Restasis MultiDose is cyclosporine. 6 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 Restasis MultiDose?
The active ingredient in Restasis MultiDose is cyclosporine, per the FDA Orange Book.
When does the Restasis MultiDose patent expire?
The last patent listed for Restasis MultiDose in the Orange Book expires May 11, 2034. 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.
More on Restasis MultiDose and Cyclosporine
- What is Restasis MultiDose used for?FDA label uses
- Is Restasis MultiDose a controlled substance?Federal schedule
- What is Cyclosporine used for?FDA label uses
- Is Cyclosporine a controlled substance?Federal schedule
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