FDA Orange Book
Generic for Zioptan
Zioptan contains tafluprost. 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 Zioptan is tafluprost. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Zioptan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.0015% | Marketed (Rx) | AT | 3 | AT |
NDA 202514, held by THEA PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tafluprost
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MICRO LABS LTD | 209051 | AT (A-rated, therapeutically equivalent) | August 19, 2019 | 0.0015% |
| SANDOZ INC | 209040 | AT (A-rated, therapeutically equivalent) | January 28, 2022 | 0.0015% |
| INGENUS PHARMACEUTICALS LLC | 218002 | AT (A-rated, therapeutically equivalent) | April 5, 2024 | 0.0015% |
Zioptan patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10864159 | May 28, 2029 | Drug product | U-778 | 202514 |
| 9999593 | May 28, 2029 | Drug product | None | 202514 |
Zioptan NDC codes
Questions
Is there a generic for Zioptan?
Yes. The generic name for Zioptan is tafluprost. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Zioptan?
The active ingredient in Zioptan is tafluprost, per the FDA Orange Book.
When does the Zioptan patent expire?
The last patent listed for Zioptan in the Orange Book expires May 28, 2029. 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.