FDA Orange Book
Generic for Ultravate
Ultravate 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 Ultravate is halobetasol propionate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Ultravate products the Orange Book lists.
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Ultravate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.05% | Discontinued | None | 3 | AB |
| lotion, topical | 0.05% | Marketed (Rx) | None | 0 | None |
| ointment, topical | 0.05% | Discontinued | None | 4 | AB |
NDA 019967, 208183, 019968, held by SUN PHARMACEUTICAL INDUSTRIES INC. 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 |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 077001 | AB (A-rated, therapeutically equivalent) | December 16, 2004 | 0.05% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 077123 | AB (A-rated, therapeutically equivalent) | December 16, 2004 | 0.05% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 076872 | AB (A-rated, therapeutically equivalent) | December 16, 2004 | 0.05% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 077109 | AB (A-rated, therapeutically equivalent) | June 14, 2005 | 0.05% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 078162 | AB (A-rated, therapeutically equivalent) | April 24, 2007 | 0.05% |
| ENCUBE ETHICALS PRIVATE LTD | 209978 | AB (A-rated, therapeutically equivalent) | March 20, 2018 | 0.05% |
| QUAGEN PHARMACEUTICALS LLC | 213560 | AB (A-rated, therapeutically equivalent) | October 6, 2020 | 0.05% |
Ultravate patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8962028 | June 19, 2033 | Drug product | U-1775 | 208183 |
Ultravate NDC codes
Questions
Is there a generic for Ultravate?
Yes. The generic name for Ultravate is halobetasol propionate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Ultravate products the Orange Book lists.
What is the generic name for Ultravate?
The active ingredient in Ultravate is halobetasol propionate, per the FDA Orange Book.
When does the Ultravate patent expire?
The last patent listed for Ultravate in the Orange Book expires June 19, 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.