FDA Orange Book
Is there a generic for Solosec?
Solosec contains secnidazole. 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 Solosec (secnidazole). The Orange Book shows its last listed patent expires December 11, 2041 and its last listed exclusivity ends September 15, 2027.
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Solosec products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| granule, oral | 2GM/PACKET | Marketed (Rx) | None | 0 | None |
NDA 209363, held by EVOFEM INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Solosec patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10335390 | September 4, 2035 | Drug product | U-2583 | 209363 |
| 11000507 | September 4, 2035 | Drug product | U-3302 | 209363 |
| 11000507 | September 4, 2035 | Drug product | U-3270 | 209363 |
| 11020377 | September 4, 2035 | Drug product | U-3302 | 209363 |
| 11020377 | September 4, 2035 | Drug product | U-3270 | 209363 |
| 11000508 | September 4, 2035 | Drug product | U-3302 | 209363 |
| 11000508 | September 4, 2035 | Drug product | U-3270 | 209363 |
| 10682338 | September 4, 2035 | Drug product | U-3270 | 209363 |
| 10849884 | September 4, 2035 | Drug product | U-3270 | 209363 |
| 10849884 | September 4, 2035 | Drug product | U-3302 | 209363 |
| 10335390 | September 4, 2035 | Drug product | U-3270 | 209363 |
| 10857133 | September 4, 2035 | Drug product | U-3270 | 209363 |
| 11602522 | September 4, 2035 | Drug product | U-3169 | 209363 |
| 11602522 | September 4, 2035 | Drug product | U-3302 | 209363 |
| 10849884 | September 4, 2035 | Drug product | U-3169 | 209363 |
| 11000507 | September 4, 2035 | Drug product | U-3169 | 209363 |
| 11020377 | September 4, 2035 | Drug product | U-3169 | 209363 |
| 11000508 | September 4, 2035 | Drug product | U-3169 | 209363 |
| 10849884 | September 4, 2035 | Drug product | U-2583 | 209363 |
| 10857133 | September 4, 2035 | Drug product | U-2583 | 209363 |
| 10682338 | September 4, 2035 | Drug product | U-2583 | 209363 |
| 11000508 | September 4, 2035 | Drug product | U-2583 | 209363 |
| 11000507 | September 4, 2035 | Drug product | U-2583 | 209363 |
| 11020377 | September 4, 2035 | Drug product | U-2583 | 209363 |
| 11324721 | September 4, 2035 | Drug product | U-2583 | 209363 |
| 11324721 | September 4, 2035 | Drug product | U-3169 | 209363 |
| 11324721 | September 4, 2035 | Drug product | U-3270 | 209363 |
| 11324721 | September 4, 2035 | Drug product | U-3302 | 209363 |
| 11684607 | September 16, 2035 | Drug product | U-2583 | 209363 |
| 11684607 | September 16, 2035 | Drug product | U-3169 | 209363 |
| 11684607 | September 16, 2035 | Drug product | U-3270 | 209363 |
| 11684607 | September 16, 2035 | Drug product | U-3302 | 209363 |
| 12280037 | December 11, 2041 | Method of use | U-3302 | 209363 |
Solosec exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 15, 2022 | 209363 |
| GAIN | Generating Antibiotic Incentives Now | September 15, 2027 | 209363 |
Solosec NDC codes
Questions
Is there a generic for Solosec?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Solosec (secnidazole). The Orange Book shows its last listed patent expires December 11, 2041 and its last listed exclusivity ends September 15, 2027.
What is the generic name for Solosec?
The active ingredient in Solosec is secnidazole, per the FDA Orange Book.
When does the Solosec patent expire?
The last patent listed for Solosec in the Orange Book expires December 11, 2041. 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.