FDA Orange Book
Generic for Restasis
Restasis 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 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 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| emulsion, ophthalmic | 0.05% | Marketed (Rx) | AB | 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 NDC codes
Questions
Is there a generic for Restasis?
Yes. The generic name for Restasis 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?
The active ingredient in Restasis 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.
More on Restasis and Cyclosporine
- What is Restasis used for?FDA label uses
- Is Restasis a controlled substance?Federal schedule
- What is Cyclosporine used for?FDA label uses
- Is Cyclosporine a controlled substance?Federal schedule
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- Restasis Medicare Part D coverageBy plan and state
- NDC 0023-9163Restasis NDC record
- NDC 50090-4476Restasis NDC record