FDA Orange Book
Generic for Jublia
Jublia contains efinaconazole. 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 Jublia is efinaconazole. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Jublia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, topical | 10% | Marketed (Rx) | AB | 2 | AB |
NDA 203567, held by BAUSCH HEALTH AMERICAS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic efinaconazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 211827 | AB (A-rated, therapeutically equivalent) | December 16, 2020 | 10% |
| NIVAGEN PHARMACEUTICALS INC | 211969 | AB (A-rated, therapeutically equivalent) | June 21, 2021 | 10% |
Jublia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7214506 | February 22, 2026 | Method of use | U-281 | 203567 |
| 9566272 | January 3, 2028 | Method of use | U-1969 | 203567 |
| 9877955 | January 3, 2028 | Method of use | U-1969 | 203567 |
| 10512640 | January 3, 2028 | Method of use | U-1969 | 203567 |
| 11213519 | January 3, 2028 | Method of use | U-2720 | 203567 |
| 11872218 | January 3, 2028 | Method of use | U-1969 | 203567 |
| 10828369 | January 3, 2028 | Drug product | None | 203567 |
| 8039494 | July 8, 2030 | Method of use | U-281 | 203567 |
| 9861698 | July 8, 2030 | Drug product | None | 203567 |
| 10105444 | July 8, 2030 | Drug product | None | 203567 |
| 8486978 | October 24, 2030 | Drug product | None | 203567 |
| 9302009 | October 24, 2030 | Drug product | None | 203567 |
| 10342875 | October 2, 2034 | Drug product | U-2720 | 203567 |
| 11654139 | October 2, 2034 | Method of use | U-1969 | 203567 |
| 10828293 | October 2, 2034 | Method of use | U-2720 | 203567 |
| 10864274 | October 2, 2034 | Method of use | U-2720 | 203567 |
| 9662394 | October 2, 2034 | Drug product | None | 203567 |
| 10478601 | April 25, 2035 | Drug product | U-2721 | 203567 |
Jublia NDC codes
Questions
Is there a generic for Jublia?
Yes. The generic name for Jublia is efinaconazole. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Jublia?
The active ingredient in Jublia is efinaconazole, per the FDA Orange Book.
When does the Jublia patent expire?
The last patent listed for Jublia in the Orange Book expires April 25, 2035. 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.