Assyro AI

Orange Book product · Brand (NDA)

XYWAV

CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE

Brand (NDA)NDA 212690RX JAZZ
View CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE familyOpen on FDA Orange Book

At a glance

Jul 21, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

25

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 21, 2020

    6 yr ago

  2. Today

  3. Exclusivity ends · ODE-361

    Orphan-drug exclusivity (7 years)

    Jul 21, 2027

    in 1 yr 1 mo

  4. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Jan 21, 2028

    in 1 yr 7 mo

  5. Exclusivity ends · ODE-369

    Orphan-drug exclusivity (7 years)

    Aug 12, 2028

    in 2 yr 2 mo

  6. Patent 10195168 expires

    Listed drug product patent expiration.

    Jan 11, 2033

    in 6 yr 8 mo

  7. Patent 10675258 expires

    Listed method-of-use patent (U-2938) expiration.

    Jan 11, 2033

    in 6 yr 8 mo

  8. Patent 11554102 expires

    Listed drug product patent expiration.

    Jan 11, 2033

    in 6 yr 8 mo

  9. Patent 8591922 expires

    Listed drug product patent expiration.

    Jan 11, 2033

    in 6 yr 8 mo

  10. Patent 8901173 expires

    Listed drug product patent expiration.

    Jan 11, 2033

    in 6 yr 8 mo

  11. Patent 9132107 expires

    Listed drug product patent expiration.

    Jan 11, 2033

    in 6 yr 8 mo

  12. Patent 10213400 expires

    Listed method-of-use patent (U-2499) expiration.

    Mar 15, 2033

    in 6 yr 10 mo

  13. Patent 10864181 expires

    Listed method-of-use patent (U-3017) expiration.

    Mar 15, 2033

    in 6 yr 10 mo

  14. Patent 11253494 expires

    Listed method-of-use patent (U-3323) expiration.

    Mar 15, 2033

    in 6 yr 10 mo

  15. Patent 11253494 expires

    Listed method-of-use patent (U-3324) expiration.

    Mar 15, 2033

    in 6 yr 10 mo

  16. Patent 11986446 expires

    Listed method-of-use patent (U-3017) expiration.

    Mar 15, 2033

    in 6 yr 10 mo

  17. Patent 11986446 expires

    Listed method-of-use patent (U-3324) expiration.

    Mar 15, 2033

    in 6 yr 10 mo

  18. Patent 8772306 expires

    Listed method-of-use patent (U-3198) expiration.

    Mar 15, 2033

    in 6 yr 10 mo

  19. Patent 8772306 expires

    Listed method-of-use patent (U-1532) expiration.

    Mar 15, 2033

    in 6 yr 10 mo

  20. Patent 9050302 expires

    Listed method-of-use patent (U-1532) expiration.

    Mar 15, 2033

    in 6 yr 10 mo

  21. Patent 9486426 expires

    Listed method-of-use patent (U-1532) expiration.

    Mar 15, 2033

    in 6 yr 10 mo

  22. Patent 10213400*PED expires

    Listed listed patent expiration.

    Sep 15, 2033

    in 7 yr 4 mo

  23. Patent 10864181*PED expires

    Listed listed patent expiration.

    Sep 15, 2033

    in 7 yr 4 mo

  24. Patent 11253494*PED expires

    Listed listed patent expiration.

    Sep 15, 2033

    in 7 yr 4 mo

  25. Patent 8772306*PED expires

    Listed listed patent expiration.

    Sep 15, 2033

    in 7 yr 4 mo

  26. Patent 9050302*PED expires

    Listed listed patent expiration.

    Sep 15, 2033

    in 7 yr 4 mo

  27. Patent 9486426*PED expires

    Listed listed patent expiration.

    Sep 15, 2033

    in 7 yr 4 mo

  28. Patent 11426373 expires

    Listed method-of-use patent (U-3432) expiration.

    Sep 19, 2037

    in 11 yr 5 mo

  29. Patent 12138233 expires

    Listed method-of-use patent (U-4044) expiration.

    Feb 22, 2041

    in 14 yr 11 mo

  30. Patent 12582622 expires

    Listed method-of-use patent (U-4044) expiration.

    Feb 22, 2041

    in 14 yr 11 mo

Pharmaceutical detail

Active ingredient

CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE

Strength

0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 212690

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)

  • ODE-361Orphan-drug exclusivity (7 years)

    Jul 21, 2027

    in 1 yr 1 mo

  • PEDPediatric exclusivity (adds 6 months)

    Jan 21, 2028

    in 1 yr 7 mo

  • ODE-369Orphan-drug exclusivity (7 years)

    Aug 12, 2028

    in 2 yr 2 mo

Listed patents (25)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10195168Jan 11, 2033in 6 yr 8 mo
Product
10675258Jan 11, 2033in 6 yr 8 mo
U-2938
11554102Jan 11, 2033in 6 yr 8 mo
Product
8591922Jan 11, 2033in 6 yr 8 mo
Product
8901173Jan 11, 2033in 6 yr 8 mo
Product
9132107Jan 11, 2033in 6 yr 8 mo
Product
10213400Mar 15, 2033in 6 yr 10 mo
U-2499
10864181Mar 15, 2033in 6 yr 10 mo
U-3017
11253494Mar 15, 2033in 6 yr 10 mo
U-3323
11253494Mar 15, 2033in 6 yr 10 mo
U-3324
11986446Mar 15, 2033in 6 yr 10 mo
U-3017
11986446Mar 15, 2033in 6 yr 10 mo
U-3324
8772306Mar 15, 2033in 6 yr 10 mo
U-3198
8772306Mar 15, 2033in 6 yr 10 mo
U-1532
9050302Mar 15, 2033in 6 yr 10 mo
U-1532
9486426Mar 15, 2033in 6 yr 10 mo
U-1532
10213400*PEDSep 15, 2033in 7 yr 4 mo
10864181*PEDSep 15, 2033in 7 yr 4 mo
11253494*PEDSep 15, 2033in 7 yr 4 mo
8772306*PEDSep 15, 2033in 7 yr 4 mo
9050302*PEDSep 15, 2033in 7 yr 4 mo
9486426*PEDSep 15, 2033in 7 yr 4 mo
11426373Sep 19, 2037in 11 yr 5 mo
U-3432
12138233Feb 22, 2041in 14 yr 11 mo
U-4044
12582622Feb 22, 2041in 14 yr 11 mo
U-4044
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