FDA Orange Book
Is there a generic for Zerviate?
Zerviate contains cetirizine. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zerviate (cetirizine). The Orange Book shows its last listed patent expires January 9, 2033.
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Zerviate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | EQ 0.24% BASE | Marketed (Rx) | None | 0 | None |
NDA 208694, held by HARROW EYE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zerviate patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9993471 | March 15, 2030 | Method of use | U-1680 | 208694 |
| 8829005 | March 15, 2030 | Method of use | U-1680 | 208694 |
| 9750684 | March 15, 2030 | Drug product | None | 208694 |
| 8829005*PED | September 15, 2030 | Method of use | None | 208694 |
| 9254286 | July 9, 2032 | Drug product | None | 208694 |
| 9254286*PED | January 9, 2033 | Method of use | None | 208694 |
Zerviate NDC codes
Questions
Is there a generic for Zerviate?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zerviate (cetirizine). The Orange Book shows its last listed patent expires January 9, 2033.
What is the generic name for Zerviate?
The active ingredient in Zerviate is cetirizine, per the FDA Orange Book.
When does the Zerviate patent expire?
The last patent listed for Zerviate in the Orange Book expires January 9, 2033. 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 Zerviate and Cetirizine
- What is Zerviate used for?FDA label uses
- Is Zerviate a controlled substance?Federal schedule
- What is Cetirizine used for?FDA label uses
- Is Cetirizine a controlled substance?Federal schedule
- Generic for QuzyttirFDA Orange Book
- Generic for ZyrtecFDA Orange Book
- Histamine-1 Receptor Antagonists listFDA drug class
- NDC 82667-015Zerviate NDC record