FDA Orange Book
Is there a generic for Phexx?
Phexx contains citric acid, lactic acid and potassium bitartrate. 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 Phexx (citric acid, lactic acid and potassium bitartrate). The Orange Book shows its last listed patent expires March 15, 2033.
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Phexx products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, vaginal | 1%;1.8%;0.4% | Marketed (Rx) | None | 0 | None |
NDA 208352, held by EVOFEM INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Phexx patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11337989 | March 15, 2033 | Method of use | U-1 | 208352 |
| 11992472 | March 15, 2033 | Method of use | U-1 | 208352 |
| 10568855 | March 15, 2033 | Method of use | U-1 | 208352 |
| 11439610 | March 15, 2033 | Drug substance, Drug product | None | 208352 |
Phexx NDC codes
Questions
Is there a generic for Phexx?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Phexx (citric acid, lactic acid and potassium bitartrate). The Orange Book shows its last listed patent expires March 15, 2033.
What is the generic name for Phexx?
The active ingredient in Phexx is citric acid, lactic acid and potassium bitartrate, per the FDA Orange Book.
When does the Phexx patent expire?
The last patent listed for Phexx in the Orange Book expires March 15, 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.