FDA Orange Book
Is there a generic for Sorilux?
Sorilux contains calcipotriene. 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 Sorilux (calcipotriene). The Orange Book shows its last listed patent expires May 7, 2028.
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Sorilux products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, foam, topical | 0.005% | Marketed (Rx) | None | 0 | None |
NDA 022563, 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.
Sorilux patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8629128 | May 26, 2026 | Drug product | U-1280 | 022563 |
| 8629128 | May 26, 2026 | Drug product | U-1767 | 022563 |
| 8629128 | May 26, 2026 | Drug product | U-2662 | 022563 |
| 8263580 | May 7, 2028 | Drug product | U-1280 | 022563 |
| 8263580 | May 7, 2028 | Drug product | U-2662 | 022563 |
Sorilux NDC codes
Questions
Is there a generic for Sorilux?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sorilux (calcipotriene). The Orange Book shows its last listed patent expires May 7, 2028.
What is the generic name for Sorilux?
The active ingredient in Sorilux is calcipotriene, per the FDA Orange Book.
When does the Sorilux patent expire?
The last patent listed for Sorilux in the Orange Book expires May 7, 2028. 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.