FDA Orange Book · active-ingredient family
Secnidazole
Secnidazole is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SOLOSEC · NDA 209363
1
Brand (NDA)
0
Generics (ANDA)
11
Listed patents
2
Exclusivity periods
Brand (NDA) products · granule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SOLOSECRLD | EVOFEM INC | NDA 209363 | — | Sep 15, 2017 |
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Sep 15, 2022
3 yr 10 mo ago
- GAINQualified infectious disease product exclusivity (adds 5 years)
Sep 15, 2027
in 1 yr 3 mo
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10335390 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-2583 |
| 11000507 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3302 |
| 11020377 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3302 |
| 11000508 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3302 |
| 10682338 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3270 |
| 10849884 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3270 |
| 10857133 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3270 |
| 11602522 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3169 |
| 11324721 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-2583 |
| 11684607 | Sep 16, 2035 | in 9 yr 5 mo | ProductU-2583 |
| 12280037 | Dec 11, 2041 | in 15 yr 8 mo | U-3302 |
Secnidazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
