Assyro AI

Orange Book product · Brand (NDA)

SOLOSEC

SECNIDAZOLE

Brand (NDA)NDA 209363RX EVOFEM INC

At a glance

Sep 15, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

33

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 15, 2017

    8 yr 11 mo ago

  2. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Sep 15, 2022

    3 yr 10 mo ago

  3. Today

  4. Exclusivity ends · GAIN

    Qualified infectious disease product exclusivity (adds 5 years)

    Sep 15, 2027

    in 1 yr 3 mo

  5. Patent 10335390 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  6. Patent 10335390 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  7. Patent 10682338 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  8. Patent 10682338 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  9. Patent 10849884 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  10. Patent 10849884 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  11. Patent 10849884 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  12. Patent 10849884 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  13. Patent 10857133 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  14. Patent 10857133 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  15. Patent 11000507 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  16. Patent 11000507 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  17. Patent 11000507 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  18. Patent 11000507 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  19. Patent 11000508 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  20. Patent 11000508 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  21. Patent 11000508 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  22. Patent 11000508 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  23. Patent 11020377 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  24. Patent 11020377 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  25. Patent 11020377 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  26. Patent 11020377 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  27. Patent 11324721 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  28. Patent 11324721 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  29. Patent 11324721 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  30. Patent 11324721 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  31. Patent 11602522 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  32. Patent 11602522 expires

    Listed drug product patent expiration.

    Sep 04, 2035

    in 9 yr 4 mo

  33. Patent 11684607 expires

    Listed drug product patent expiration.

    Sep 16, 2035

    in 9 yr 5 mo

  34. Patent 11684607 expires

    Listed drug product patent expiration.

    Sep 16, 2035

    in 9 yr 5 mo

  35. Patent 11684607 expires

    Listed drug product patent expiration.

    Sep 16, 2035

    in 9 yr 5 mo

  36. Patent 11684607 expires

    Listed drug product patent expiration.

    Sep 16, 2035

    in 9 yr 5 mo

  37. 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 family

This 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)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10335390Sep 04, 2035in 9 yr 4 mo
ProductU-2583
10335390Sep 04, 2035in 9 yr 4 mo
ProductU-3270
10682338Sep 04, 2035in 9 yr 4 mo
ProductU-3270
10682338Sep 04, 2035in 9 yr 4 mo
ProductU-2583
10849884Sep 04, 2035in 9 yr 4 mo
ProductU-3270
10849884Sep 04, 2035in 9 yr 4 mo
ProductU-3302
10849884Sep 04, 2035in 9 yr 4 mo
ProductU-3169
10849884Sep 04, 2035in 9 yr 4 mo
ProductU-2583
10857133Sep 04, 2035in 9 yr 4 mo
ProductU-3270
10857133Sep 04, 2035in 9 yr 4 mo
ProductU-2583
11000507Sep 04, 2035in 9 yr 4 mo
ProductU-3302
11000507Sep 04, 2035in 9 yr 4 mo
ProductU-3270
11000507Sep 04, 2035in 9 yr 4 mo
ProductU-3169
11000507Sep 04, 2035in 9 yr 4 mo
ProductU-2583
11000508Sep 04, 2035in 9 yr 4 mo
ProductU-3302
11000508Sep 04, 2035in 9 yr 4 mo
ProductU-3270
11000508Sep 04, 2035in 9 yr 4 mo
ProductU-3169
11000508Sep 04, 2035in 9 yr 4 mo
ProductU-2583
11020377Sep 04, 2035in 9 yr 4 mo
ProductU-3302
11020377Sep 04, 2035in 9 yr 4 mo
ProductU-3270
11020377Sep 04, 2035in 9 yr 4 mo
ProductU-3169
11020377Sep 04, 2035in 9 yr 4 mo
ProductU-2583
11324721Sep 04, 2035in 9 yr 4 mo
ProductU-2583
11324721Sep 04, 2035in 9 yr 4 mo
ProductU-3169
11324721Sep 04, 2035in 9 yr 4 mo
ProductU-3270
11324721Sep 04, 2035in 9 yr 4 mo
ProductU-3302
11602522Sep 04, 2035in 9 yr 4 mo
ProductU-3169
11602522Sep 04, 2035in 9 yr 4 mo
ProductU-3302
11684607Sep 16, 2035in 9 yr 5 mo
ProductU-2583
11684607Sep 16, 2035in 9 yr 5 mo
ProductU-3169
11684607Sep 16, 2035in 9 yr 5 mo
ProductU-3270
11684607Sep 16, 2035in 9 yr 5 mo
ProductU-3302
12280037Dec 11, 2041in 15 yr 8 mo
U-3302
Agent CTA Background

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