Assyro AI

Orange Book product · Brand (NDA)

LUMRYZ

SODIUM OXYBATE

Brand (NDA)NDA 214755RX AVADEL CNS
View SODIUM OXYBATE familyOpen on FDA Orange Book

At a glance

May 01, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

28

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 01, 2023

    3 yr 2 mo ago

  2. Exclusivity ends · NP

    New product exclusivity (3 years)

    May 01, 2026

    2 mo ago

  3. Today

  4. Exclusivity ends · ODE-431

    Orphan-drug exclusivity (7 years)

    May 01, 2030

    in 3 yr 11 mo

  5. Exclusivity ends · ODE-494

    Orphan-drug exclusivity (7 years)

    Oct 16, 2031

    in 5 yr 5 mo

  6. Patent 10272062 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  7. Patent 10736866 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  8. Patent 10952986 expires

    Listed method-of-use patent (U-3601) expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  9. Patent 10973795 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  10. Patent 11000498 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  11. Patent 11052061 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  12. Patent 11065224 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  13. Patent 11400065 expires

    Listed method-of-use patent (U-3579) expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  14. Patent 11504347 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  15. Patent 11602512 expires

    Listed method-of-use patent (U-3577) expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  16. Patent 11602513 expires

    Listed method-of-use patent (U-3576) expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  17. Patent 11766418 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  18. Patent 11839597 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  19. Patent 11896572 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  20. Patent 11986451 expires

    Listed method-of-use patent (U-3934) expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  21. Patent 12097175 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  22. Patent 12097176 expires

    Listed method-of-use patent (U-4006) expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  23. Patent 12109186 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  24. Patent 12115142 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  25. Patent 12115143 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  26. Patent 12115144 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  27. Patent 12115145 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  28. Patent 12128021 expires

    Listed method-of-use patent (U-4022) expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  29. Patent 12138239 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  30. Patent 12144793 expires

    Listed drug product patent expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  31. Patent 12303478 expires

    Listed method-of-use patent (U-4189) expiration.

    Jul 21, 2037

    in 11 yr 3 mo

  32. Patent 11583510 expires

    Listed method-of-use patent (U-3578) expiration.

    Feb 07, 2042

    in 15 yr 10 mo

  33. Patent 11779557 expires

    Listed method-of-use patent (U-3705) expiration.

    Mar 16, 2042

    in 16 yr

Pharmaceutical detail

Active ingredient

SODIUM OXYBATE

Strength

4.5GM/PACKET

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 214755

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 (3)

  • NPNew product exclusivity (3 years)

    May 01, 2026

    2 mo ago

  • ODE-431Orphan-drug exclusivity (7 years)

    May 01, 2030

    in 3 yr 11 mo

  • ODE-494Orphan-drug exclusivity (7 years)

    Oct 16, 2031

    in 5 yr 5 mo

Listed patents (28)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10272062Jul 21, 2037in 11 yr 3 mo
Product
10736866Jul 21, 2037in 11 yr 3 mo
Product
10952986Jul 21, 2037in 11 yr 3 mo
U-3601
10973795Jul 21, 2037in 11 yr 3 mo
Product
11000498Jul 21, 2037in 11 yr 3 mo
ProductU-3580
11052061Jul 21, 2037in 11 yr 3 mo
Product
11065224Jul 21, 2037in 11 yr 3 mo
Product
11400065Jul 21, 2037in 11 yr 3 mo
U-3579
11504347Jul 21, 2037in 11 yr 3 mo
Product
11602512Jul 21, 2037in 11 yr 3 mo
U-3577
11602513Jul 21, 2037in 11 yr 3 mo
U-3576
11766418Jul 21, 2037in 11 yr 3 mo
Product
11839597Jul 21, 2037in 11 yr 3 mo
Product
11896572Jul 21, 2037in 11 yr 3 mo
Product
11986451Jul 21, 2037in 11 yr 3 mo
U-3934
12097175Jul 21, 2037in 11 yr 3 mo
Product
12097176Jul 21, 2037in 11 yr 3 mo
U-4006
12109186Jul 21, 2037in 11 yr 3 mo
Product
12115142Jul 21, 2037in 11 yr 3 mo
Product
12115143Jul 21, 2037in 11 yr 3 mo
Product
12115144Jul 21, 2037in 11 yr 3 mo
Product
12115145Jul 21, 2037in 11 yr 3 mo
Product
12128021Jul 21, 2037in 11 yr 3 mo
U-4022
12138239Jul 21, 2037in 11 yr 3 mo
Product
12144793Jul 21, 2037in 11 yr 3 mo
Product
12303478Jul 21, 2037in 11 yr 3 mo
U-4189
11583510Feb 07, 2042in 15 yr 10 mo
U-3578
11779557Mar 16, 2042in 16 yr
U-3705
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