FDA Orange Book
Is there a generic for Bryhali?
Bryhali 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Bryhali (halobetasol propionate). The Orange Book shows its last listed patent expires November 2, 2031.
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Bryhali products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| lotion, topical | 0.01% | Marketed (Rx) | None | 0 | None |
NDA 209355, 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.
Bryhali patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10478502 | November 2, 2031 | Drug product | U-2625 | 209355 |
| 11986527 | November 2, 2031 | Method of use | U-2625 | 209355 |
| 11839656 | November 2, 2031 | Method of use | U-2625 | 209355 |
| 11957753 | November 2, 2031 | Drug product | None | 209355 |
| 12076403 | November 2, 2031 | Drug product | None | 209355 |
| 8809307 | November 2, 2031 | Drug product | None | 209355 |
Bryhali NDC codes
Questions
Is there a generic for Bryhali?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Bryhali (halobetasol propionate). The Orange Book shows its last listed patent expires November 2, 2031.
What is the generic name for Bryhali?
The active ingredient in Bryhali is halobetasol propionate, per the FDA Orange Book.
When does the Bryhali patent expire?
The last patent listed for Bryhali in the Orange Book expires November 2, 2031. 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.