FDA Orange Book
Generic for Duobrii
Duobrii contains halobetasol propionate and tazarotene. 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 Duobrii is halobetasol propionate and tazarotene. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Duobrii and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Duobrii products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| lotion, topical | 0.01%;0.045% | Marketed (Rx) | AB | 1 | AB |
NDA 209354, held by BAUSCH HEALTH AMERICAS 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 and tazarotene
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 217190 | AB (A-rated, therapeutically equivalent) | May 2, 2025 | 0.01%;0.045% |
Duobrii patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10478502 | November 2, 2031 | Drug product | U-2625 | 209354 |
| 11839656 | November 2, 2031 | Method of use | U-2625 | 209354 |
| 11986527 | November 2, 2031 | Method of use | U-2625 | 209354 |
| 12076403 | November 2, 2031 | Drug product | None | 209354 |
| 8809307 | November 2, 2031 | Drug product | None | 209354 |
| 11957753 | November 2, 2031 | Drug product | None | 209354 |
| 10426787 | June 6, 2036 | Method of use | U-2625 | 209354 |
| 11648256 | June 6, 2036 | Drug product | U-2625 | 209354 |
| 11679115 | June 6, 2036 | Drug product | U-2625 | 209354 |
| 10251895 | June 6, 2036 | Drug product | None | 209354 |
Duobrii NDC codes
Questions
Is there a generic for Duobrii?
Yes. The generic name for Duobrii is halobetasol propionate and tazarotene. 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 Duobrii?
The active ingredient in Duobrii is halobetasol propionate and tazarotene, per the FDA Orange Book.
When does the Duobrii patent expire?
The last patent listed for Duobrii in the Orange Book expires June 6, 2036. 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.