FDA Orange Book
Is there a generic for Enstilar?
Enstilar 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 Enstilar (calcipotriene and betamethasone dipropionate). The Orange Book shows its last listed patent expires December 10, 2031.
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Enstilar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, foam, topical | 0.064%;0.005% | Marketed (Rx) | None | 0 | None |
NDA 207589, held by LEO PHARMA AS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Enstilar patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9119781 | June 10, 2031 | Drug product | U-1761 | 207589 |
| 9119781 | June 10, 2031 | Drug product | U-2627 | 207589 |
| 10688108 | June 10, 2031 | Method of use | U-2627 | 207589 |
| 10660908 | June 10, 2031 | Drug product | U-2627 | 207589 |
| 9566286 | June 10, 2031 | Drug product | None | 207589 |
| 10130640 | June 10, 2031 | Drug product | None | 207589 |
| 10617698 | June 10, 2031 | Drug product | None | 207589 |
| 10682364 | June 10, 2031 | Drug product | None | 207589 |
| 10716799 | June 10, 2031 | Drug product | None | 207589 |
| 9119781*PED | December 10, 2031 | Method of use | None | 207589 |
| 10130640*PED | December 10, 2031 | Method of use | None | 207589 |
Enstilar NDC codes
Questions
Is there a generic for Enstilar?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Enstilar (calcipotriene and betamethasone dipropionate). The Orange Book shows its last listed patent expires December 10, 2031.
What is the generic name for Enstilar?
The active ingredient in Enstilar is calcipotriene and betamethasone dipropionate, per the FDA Orange Book.
When does the Enstilar patent expire?
The last patent listed for Enstilar in the Orange Book expires December 10, 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.