FDA Orange Book
Generic for Vyzulta
Vyzulta contains latanoprostene bunod. 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 Vyzulta is latanoprostene bunod. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Vyzulta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.024% | Marketed (Rx) | AB | 1 | AB |
NDA 207795, held by BAUSCH AND LOMB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic latanoprostene bunod
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GLAND PHARMA LTD | 217387 | AB (A-rated, therapeutically equivalent) | April 29, 2025 | 0.024% |
Vyzulta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8058467 | February 21, 2029 | Drug substance | U-2144 | 207795 |
Vyzulta NDC codes
Questions
Is there a generic for Vyzulta?
Yes. The generic name for Vyzulta is latanoprostene bunod. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Vyzulta?
The active ingredient in Vyzulta is latanoprostene bunod, per the FDA Orange Book.
When does the Vyzulta patent expire?
The last patent listed for Vyzulta in the Orange Book expires February 21, 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.