FDA Orange Book
Generic for Lexette
Lexette contains halobetasol propionate. 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 Lexette is halobetasol propionate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Lexette products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, foam, topical | 0.05% | Discontinued | None | 1 | None |
NDA 210566, held by MAYNE PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic halobetasol propionate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 215266 | None (No TE code listed) | August 11, 2023 | 0.05% |
Lexette patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11020407 | November 30, 2036 | Drug product | U-3143 | 210566 |
| 10857159 | November 30, 2036 | Drug product | None | 210566 |
| 10857159*PED | May 30, 2037 | Method of use | None | 210566 |
Questions
Is there a generic for Lexette?
Yes. The generic name for Lexette is halobetasol propionate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Lexette?
The active ingredient in Lexette is halobetasol propionate, per the FDA Orange Book.
When does the Lexette patent expire?
The last patent listed for Lexette in the Orange Book expires May 30, 2037. 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.