FDA Orange Book
Generic for Dovonex
Dovonex 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
Yes. The generic name for Dovonex is calcipotriene. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
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Dovonex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.005% | Marketed (Rx) | AB | 1 | AB |
| ointment, topical | 0.005% | Marketed (Rx) | AB | 1 | AB |
| solution, topical | 0.005% | Discontinued | None | 3 | AT |
NDA 020554, 020273, 020611, 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.
Approved generic calcipotriene
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 078305 | AT (A-rated, therapeutically equivalent) | May 6, 2008 | 0.005% |
| GLENMARK PHARMACEUTICALS INC USA | 090633 | AB (A-rated, therapeutically equivalent) | March 24, 2010 | 0.005% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 078468 | AT (A-rated, therapeutically equivalent) | March 24, 2011 | 0.005% |
| GLENMARK SPECIALTY SA | 205772 | AB (A-rated, therapeutically equivalent) | June 9, 2015 | 0.005% |
| CHARTWELL RX SCIENCES LLC | 207163 | AT (A-rated, therapeutically equivalent) | December 26, 2017 | 0.005% |
Dovonex NDC codes
Questions
Is there a generic for Dovonex?
Yes. The generic name for Dovonex is calcipotriene. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
What is the generic name for Dovonex?
The active ingredient in Dovonex is calcipotriene, per the FDA Orange Book.
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.