Assyro AI

Orange Book product · Brand (NDA)

OGSIVEO

NIROGACESTAT HYDROBROMIDE

Brand (NDA)NDA 217677DISCN SPRINGWORKS

At a glance

Nov 27, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

29

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 27, 2023

    2 yr 7 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Nov 27, 2028

    in 2 yr 6 mo

  4. Patent 7795447 expires

    Listed drug substance patent expiration.

    Aug 18, 2030

    in 4 yr 3 mo

  5. Exclusivity ends · ODE-452

    Orphan-drug exclusivity (7 years)

    Nov 27, 2030

    in 4 yr 6 mo

  6. Patent 10590087 expires

    Listed drug substance patent expiration.

    Aug 09, 2039

    in 13 yr 4 mo

  7. Patent 10710966 expires

    Listed drug substance patent expiration.

    Aug 09, 2039

    in 13 yr 4 mo

  8. Patent 10941118 expires

    Listed drug substance patent expiration.

    Aug 09, 2039

    in 13 yr 4 mo

  9. Patent 11820748 expires

    Listed drug product patent expiration.

    Aug 09, 2039

    in 13 yr 4 mo

  10. Patent 11845732 expires

    Listed drug substance patent expiration.

    Aug 09, 2039

    in 13 yr 4 mo

  11. Patent 11884634 expires

    Listed drug product patent expiration.

    Aug 09, 2039

    in 13 yr 4 mo

  12. Patent 11884635 expires

    Listed drug product patent expiration.

    Aug 09, 2039

    in 13 yr 4 mo

  13. Patent 11905255 expires

    Listed drug product patent expiration.

    Aug 09, 2039

    in 13 yr 4 mo

  14. Patent 12116347 expires

    Listed drug product patent expiration.

    Aug 09, 2039

    in 13 yr 4 mo

  15. Patent 12297177 expires

    Listed drug product patent expiration.

    Aug 09, 2039

    in 13 yr 4 mo

  16. Patent 11504354 expires

    Listed drug product patent expiration.

    Jul 08, 2042

    in 16 yr 3 mo

  17. Patent 11612588 expires

    Listed drug product patent expiration.

    Jul 08, 2042

    in 16 yr 3 mo

  18. Patent 12110277 expires

    Listed drug product patent expiration.

    Jul 08, 2042

    in 16 yr 3 mo

  19. Patent 12234210 expires

    Listed drug product patent expiration.

    Jul 08, 2042

    in 16 yr 3 mo

  20. Patent 12247012 expires

    Listed drug product patent expiration.

    Jul 08, 2042

    in 16 yr 3 mo

  21. Patent 12599587 expires

    Listed drug product patent expiration.

    Jul 08, 2042

    in 16 yr 3 mo

  22. Patent 11807611 expires

    Listed drug product patent expiration.

    Sep 08, 2042

    in 16 yr 6 mo

  23. Patent 11844780 expires

    Listed drug product patent expiration.

    Sep 08, 2042

    in 16 yr 6 mo

  24. Patent 11872211 expires

    Listed method-of-use patent (U-3754) expiration.

    May 19, 2043

    in 17 yr 2 mo

  25. Patent 11925619 expires

    Listed method-of-use patent (U-3754) expiration.

    May 19, 2043

    in 17 yr 2 mo

  26. Patent 11925620 expires

    Listed method-of-use patent (U-3754) expiration.

    May 19, 2043

    in 17 yr 2 mo

  27. Patent 11938116 expires

    Listed method-of-use patent (U-3754) expiration.

    May 19, 2043

    in 17 yr 2 mo

  28. Patent 11951096 expires

    Listed method-of-use patent (U-3754) expiration.

    May 19, 2043

    in 17 yr 2 mo

  29. Patent 11957662 expires

    Listed method-of-use patent (U-3754) expiration.

    May 19, 2043

    in 17 yr 2 mo

  30. Patent 12011434 expires

    Listed method-of-use patent (U-3754) expiration.

    May 19, 2043

    in 17 yr 2 mo

  31. Patent 12011435 expires

    Listed method-of-use patent (U-3754) expiration.

    May 19, 2043

    in 17 yr 2 mo

  32. Patent 12036207 expires

    Listed method-of-use patent (U-3754) expiration.

    May 19, 2043

    in 17 yr 2 mo

  33. Patent 12138246 expires

    Listed method-of-use patent (U-3754) expiration.

    May 19, 2043

    in 17 yr 2 mo

Pharmaceutical detail

Active ingredient

NIROGACESTAT HYDROBROMIDE

Strength

EQ 50MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 217677

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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)

    Nov 27, 2028

    in 2 yr 6 mo

  • ODE-452Orphan-drug exclusivity (7 years)

    Nov 27, 2030

    in 4 yr 6 mo

Listed patents (29)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7795447Aug 18, 2030in 4 yr 3 mo
Substance
10590087Aug 09, 2039in 13 yr 4 mo
Substance
10710966Aug 09, 2039in 13 yr 4 mo
SubstanceU-3754
10941118Aug 09, 2039in 13 yr 4 mo
SubstanceU-3754
11820748Aug 09, 2039in 13 yr 4 mo
Product
11845732Aug 09, 2039in 13 yr 4 mo
SubstanceU-3754
11884634Aug 09, 2039in 13 yr 4 mo
Product
11884635Aug 09, 2039in 13 yr 4 mo
Product
11905255Aug 09, 2039in 13 yr 4 mo
Product
12116347Aug 09, 2039in 13 yr 4 mo
Product
12297177Aug 09, 2039in 13 yr 4 mo
Product
11504354Jul 08, 2042in 16 yr 3 mo
Product
11612588Jul 08, 2042in 16 yr 3 mo
ProductU-3754
12110277Jul 08, 2042in 16 yr 3 mo
Product
12234210Jul 08, 2042in 16 yr 3 mo
Product
12247012Jul 08, 2042in 16 yr 3 mo
Product
12599587Jul 08, 2042in 16 yr 3 mo
Product
11807611Sep 08, 2042in 16 yr 6 mo
ProductU-3754
11844780Sep 08, 2042in 16 yr 6 mo
ProductU-3754
11872211May 19, 2043in 17 yr 2 mo
U-3754
11925619May 19, 2043in 17 yr 2 mo
U-3754
11925620May 19, 2043in 17 yr 2 mo
U-3754
11938116May 19, 2043in 17 yr 2 mo
U-3754
11951096May 19, 2043in 17 yr 2 mo
U-3754
11957662May 19, 2043in 17 yr 2 mo
U-3754
12011434May 19, 2043in 17 yr 2 mo
U-3754
12011435May 19, 2043in 17 yr 2 mo
U-3754
12036207May 19, 2043in 17 yr 2 mo
U-3754
12138246May 19, 2043in 17 yr 2 mo
U-3754
Agent CTA Background

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