Orange Book product · Brand (NDA)
SOLOSEC
SECNIDAZOLE
At a glance
Sep 15, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
33
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 15, 2017
8 yr 11 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 15, 2022
3 yr 10 mo ago
Today
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Sep 15, 2027
in 1 yr 3 mo
Patent 10335390 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 10335390 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 10682338 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 10682338 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 10849884 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 10849884 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 10849884 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 10849884 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 10857133 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 10857133 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11000507 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11000507 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11000507 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11000507 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11000508 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11000508 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11000508 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11000508 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11020377 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11020377 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11020377 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11020377 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11324721 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11324721 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11324721 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11324721 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11602522 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11602522 expires
Listed drug product patent expiration.
Sep 04, 2035
in 9 yr 4 mo
Patent 11684607 expires
Listed drug product patent expiration.
Sep 16, 2035
in 9 yr 5 mo
Patent 11684607 expires
Listed drug product patent expiration.
Sep 16, 2035
in 9 yr 5 mo
Patent 11684607 expires
Listed drug product patent expiration.
Sep 16, 2035
in 9 yr 5 mo
Patent 11684607 expires
Listed drug product patent expiration.
Sep 16, 2035
in 9 yr 5 mo
Patent 12280037 expires
Listed method-of-use patent (U-3302) expiration.
Dec 11, 2041
in 15 yr 8 mo
Pharmaceutical detail
Active ingredient
SECNIDAZOLE
Strength
2GM/PACKET
Dosage form
GRANULE
Route
ORAL
TE code
Not listed
Application
NDA 209363
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
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 (33)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10335390 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-2583 |
| 10335390 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3270 |
| 10682338 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3270 |
| 10682338 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-2583 |
| 10849884 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3270 |
| 10849884 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3302 |
| 10849884 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3169 |
| 10849884 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-2583 |
| 10857133 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3270 |
| 10857133 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-2583 |
| 11000507 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3302 |
| 11000507 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3270 |
| 11000507 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3169 |
| 11000507 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-2583 |
| 11000508 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3302 |
| 11000508 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3270 |
| 11000508 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3169 |
| 11000508 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-2583 |
| 11020377 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3302 |
| 11020377 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3270 |
| 11020377 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3169 |
| 11020377 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-2583 |
| 11324721 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-2583 |
| 11324721 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3169 |
| 11324721 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3270 |
| 11324721 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3302 |
| 11602522 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3169 |
| 11602522 | Sep 04, 2035 | in 9 yr 4 mo | ProductU-3302 |
| 11684607 | Sep 16, 2035 | in 9 yr 5 mo | ProductU-2583 |
| 11684607 | Sep 16, 2035 | in 9 yr 5 mo | ProductU-3169 |
| 11684607 | Sep 16, 2035 | in 9 yr 5 mo | ProductU-3270 |
| 11684607 | Sep 16, 2035 | in 9 yr 5 mo | ProductU-3302 |
| 12280037 | Dec 11, 2041 | in 15 yr 8 mo | U-3302 |

