FDA Orange Book
Is there a generic for Wynzora?
Wynzora contains calcipotriene and betamethasone dipropionate. 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 Wynzora (calcipotriene and betamethasone dipropionate). The Orange Book shows its last listed patent expires March 18, 2039.
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Wynzora products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.064%;0.005% | Marketed (Rx) | None | 0 | None |
NDA 213422, held by MC2 THERAPEUTICS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Wynzora patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10265265 | September 27, 2027 | Drug product | None | 213422 |
| 12440499 | March 18, 2039 | Drug product | U-1408 | 213422 |
| 11696919 | March 18, 2039 | Drug product | None | 213422 |
Wynzora NDC codes
Questions
Is there a generic for Wynzora?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Wynzora (calcipotriene and betamethasone dipropionate). The Orange Book shows its last listed patent expires March 18, 2039.
What is the generic name for Wynzora?
The active ingredient in Wynzora is calcipotriene and betamethasone dipropionate, per the FDA Orange Book.
When does the Wynzora patent expire?
The last patent listed for Wynzora in the Orange Book expires March 18, 2039. 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.