FDA Orange Book
Is there a generic for Sofdra?
Sofdra contains sofpironium bromide. 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 Sofdra (sofpironium bromide). The Orange Book shows its last listed patent expires May 22, 2040 and its last listed exclusivity ends June 20, 2029.
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Sofdra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, metered, topical | EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | Marketed (Rx) | None | 0 | None |
NDA 217347, held by BOTANIX SB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Sofdra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8147809 | March 26, 2027 | Drug substance, Drug product | None | 217347 |
| 8628759 | November 13, 2027 | Method of use | U-2398 | 217347 |
| 10383846 | March 14, 2034 | Method of use | U-2398 | 217347 |
| 9492429 | March 14, 2034 | Drug product | U-2398 | 217347 |
| 9895350 | March 14, 2034 | Method of use | U-2398 | 217347 |
| 9220707 | March 14, 2034 | Method of use | U-2398 | 217347 |
| 12357609 | May 22, 2034 | Drug product | U-2398 | 217347 |
| 12156865 | May 22, 2034 | Drug product | U-2398 | 217347 |
| 12398102 | May 22, 2034 | Drug product | U-2398 | 217347 |
| 11084788 | May 22, 2034 | Drug product | U-2398 | 217347 |
| 11052067 | May 22, 2034 | Drug product | U-2398 | 217347 |
| 11034652 | May 22, 2034 | Drug product | U-2398 | 217347 |
| 11026919 | May 22, 2034 | Drug product | U-2398 | 217347 |
| 10961191 | May 22, 2034 | Method of use | U-2398 | 217347 |
| 10959983 | May 22, 2034 | Method of use | U-2398 | 217347 |
| 10952990 | May 22, 2034 | Method of use | U-2398 | 217347 |
| 10947192 | May 22, 2034 | Method of use | U-2398 | 217347 |
| 11123325 | July 20, 2037 | Drug product | U-2398 | 217347 |
| 12703682 | May 22, 2040 | Drug substance, Drug product | None | 217347 |
| 11584715 | May 22, 2040 | Drug substance, Drug product | None | 217347 |
| 11566000 | May 22, 2040 | Drug substance, Drug product | None | 217347 |
Sofdra exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | June 20, 2029 | 217347 |
Sofdra NDC codes
Questions
Is there a generic for Sofdra?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sofdra (sofpironium bromide). The Orange Book shows its last listed patent expires May 22, 2040 and its last listed exclusivity ends June 20, 2029.
What is the generic name for Sofdra?
The active ingredient in Sofdra is sofpironium bromide, per the FDA Orange Book.
When does the Sofdra patent expire?
The last patent listed for Sofdra in the Orange Book expires May 22, 2040. 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.