FDA Orange Book
Generic for Finacea
Finacea contains azelaic acid. 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 Finacea is azelaic acid. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Finacea products the Orange Book lists.
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Finacea products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, foam, topical | 15% | Marketed (Rx) | None | 0 | None |
| gel, topical | 15% | Marketed (Rx) | AB | 4 | AB |
NDA 207071, 021470, 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 azelaic acid
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES UT INC | 208011 | AB (A-rated, therapeutically equivalent) | November 19, 2018 | 15% |
| ENCUBE ETHICALS PRIVATE LTD | 208724 | AB (A-rated, therapeutically equivalent) | November 19, 2018 | 15% |
| GLENMARK SPECIALTY SA | 204637 | AB (A-rated, therapeutically equivalent) | November 19, 2018 | 15% |
| SUN PHARMA CANADA INC | 210549 | AB (A-rated, therapeutically equivalent) | August 23, 2019 | 15% |
Finacea patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7700076 | September 18, 2027 | Drug product | None | 207071 |
| 10117812 | October 18, 2027 | Drug product | U-1796 | 207071 |
| 9265725 | December 8, 2027 | Drug product | None | 207071 |
| 9211259 | February 28, 2029 | Method of use | U-1796 | 207071 |
Finacea NDC codes
Questions
Is there a generic for Finacea?
Yes. The generic name for Finacea is azelaic acid. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Finacea products the Orange Book lists.
What is the generic name for Finacea?
The active ingredient in Finacea is azelaic acid, per the FDA Orange Book.
When does the Finacea patent expire?
The last patent listed for Finacea in the Orange Book expires February 28, 2029. 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.