FDA Orange Book
Generic for Soolantra
Soolantra contains ivermectin. 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 Soolantra is ivermectin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Soolantra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 1% | Marketed (Rx) | AB | 3 | AB |
NDA 206255, held by GALDERMA LABORATORIES LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ivermectin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 210019 | AB (A-rated, therapeutically equivalent) | September 13, 2019 | 1% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 210225 | AB (A-rated, therapeutically equivalent) | April 13, 2020 | 1% |
| ZYDUS LIFESCIENCES GLOBAL FZE | 215210 | AB (A-rated, therapeutically equivalent) | August 2, 2022 | 1% |
Soolantra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9233118 | March 13, 2034 | Method of use | U-1631 | 206255 |
| 9089587 | March 13, 2034 | Method of use | U-1631 | 206255 |
| 9233117 | March 13, 2034 | Method of use | U-1631 | 206255 |
| 9782425 | March 13, 2034 | Method of use | U-1631 | 206255 |
| 10206939 | March 13, 2034 | Method of use | U-1631 | 206255 |
Soolantra NDC codes
Questions
Is there a generic for Soolantra?
Yes. The generic name for Soolantra is ivermectin. 3 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 Soolantra?
The active ingredient in Soolantra is ivermectin, per the FDA Orange Book.
When does the Soolantra patent expire?
The last patent listed for Soolantra in the Orange Book expires March 13, 2034. 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.