Assyro AI

Orange Book product · Brand (NDA)

SUNOSI

SOLRIAMFETOL HYDROCHLORIDE

Brand (NDA)NDA 211230RX AXSOME MALTA
View SOLRIAMFETOL HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jun 17, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

42

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 17, 2019

    7 yr 1 mo ago

  2. Patent 10351517 expires

    Listed method-of-use patent (U-2548) expiration.

    Jun 07, 2026

    12 d ago

  3. Patent 11753368 expires

    Listed method-of-use patent (U-2548) expiration.

    Jun 07, 2026

    12 d ago

  4. Patent 12209059 expires

    Listed method-of-use patent (U-2548) expiration.

    Jun 07, 2026

    12 d ago

  5. Patent 8877806 expires

    Listed method-of-use patent (U-2548) expiration.

    Jun 07, 2026

    12 d ago

  6. Patent 9604917 expires

    Listed method-of-use patent (U-2548) expiration.

    Jun 07, 2026

    12 d ago

  7. Exclusivity ends · ODE-254

    Orphan-drug exclusivity (7 years)

    Jun 17, 2026

    2 d ago

  8. Today

  9. Patent 8440715 expires

    Listed method-of-use patent (U-2548) expiration.

    Jun 11, 2031

    in 5 yr 1 mo

  10. Patent 10195151 expires

    Listed drug product patent expiration.

    Sep 05, 2037

    in 11 yr 5 mo

  11. Patent 10512609 expires

    Listed method-of-use patent (U-2548) expiration.

    Sep 05, 2037

    in 11 yr 5 mo

  12. Patent 11439597 expires

    Listed drug product patent expiration.

    Sep 05, 2037

    in 11 yr 5 mo

  13. Patent 11998639 expires

    Listed drug product patent expiration.

    Sep 05, 2037

    in 11 yr 5 mo

  14. Patent 12390419 expires

    Listed drug product patent expiration.

    Sep 05, 2037

    in 11 yr 5 mo

  15. Patent 10912754 expires

    Listed method-of-use patent (U-3082) expiration.

    Jun 01, 2038

    in 12 yr 2 mo

  16. Patent 10959976 expires

    Listed method-of-use patent (U-3151) expiration.

    Jun 01, 2038

    in 12 yr 2 mo

  17. Patent 11648232 expires

    Listed method-of-use patent (U-3602) expiration.

    Jun 01, 2038

    in 12 yr 2 mo

  18. Patent 11865098 expires

    Listed method-of-use patent (U-2548) expiration.

    Jun 01, 2038

    in 12 yr 2 mo

  19. Patent 12384743 expires

    Listed drug substance patent expiration.

    Nov 01, 2038

    in 12 yr 7 mo

  20. Patent 11560354 expires

    Listed drug product patent expiration.

    Mar 06, 2039

    in 12 yr 11 mo

  21. Patent 10940133 expires

    Listed method-of-use patent (U-3099) expiration.

    Mar 19, 2040

    in 13 yr 11 mo

  22. Patent 11160779 expires

    Listed method-of-use patent (U-3521) expiration.

    Mar 19, 2040

    in 13 yr 11 mo

  23. Patent 11839598 expires

    Listed method-of-use patent (U-3765) expiration.

    Mar 19, 2040

    in 13 yr 11 mo

  24. Patent 11839599 expires

    Listed method-of-use patent (U-3764) expiration.

    Mar 19, 2040

    in 13 yr 11 mo

  25. Patent 11850226 expires

    Listed method-of-use patent (U-3775) expiration.

    Mar 19, 2040

    in 13 yr 11 mo

  26. Patent 11850227 expires

    Listed method-of-use patent (U-3775) expiration.

    Mar 19, 2040

    in 13 yr 11 mo

  27. Patent 11850228 expires

    Listed method-of-use patent (U-3775) expiration.

    Mar 19, 2040

    in 13 yr 11 mo

  28. Patent 11857528 expires

    Listed method-of-use patent (U-3521) expiration.

    Mar 19, 2040

    in 13 yr 11 mo

  29. Patent 11969404 expires

    Listed method-of-use patent (U-3892) expiration.

    Mar 19, 2040

    in 13 yr 11 mo

  30. Patent 11986454 expires

    Listed method-of-use patent (U-3775) expiration.

    Mar 19, 2040

    in 13 yr 11 mo

  31. Patent 11986455 expires

    Listed method-of-use patent (U-3521) expiration.

    Mar 19, 2040

    in 13 yr 11 mo

  32. Patent 12194016 expires

    Listed method-of-use patent (U-4106) expiration.

    Mar 19, 2040

    in 13 yr 11 mo

  33. Patent 12318362 expires

    Listed method-of-use patent (U-3765) expiration.

    Mar 19, 2040

    in 13 yr 11 mo

  34. Patent 11771666 expires

    Listed method-of-use patent (U-3693) expiration.

    Dec 30, 2042

    in 16 yr 9 mo

  35. Patent 11771667 expires

    Listed method-of-use patent (U-3693) expiration.

    Dec 30, 2042

    in 16 yr 9 mo

  36. Patent 11779554 expires

    Listed method-of-use patent (U-3693) expiration.

    Dec 30, 2042

    in 16 yr 9 mo

  37. Patent 11793776 expires

    Listed method-of-use patent (U-3693) expiration.

    Dec 30, 2042

    in 16 yr 9 mo

  38. Patent 11872203 expires

    Listed method-of-use patent (U-3693) expiration.

    Dec 30, 2042

    in 16 yr 9 mo

  39. Patent 11872204 expires

    Listed method-of-use patent (U-3693) expiration.

    Dec 30, 2042

    in 16 yr 9 mo

  40. Patent 12005036 expires

    Listed method-of-use patent (U-3693) expiration.

    Dec 30, 2042

    in 16 yr 9 mo

  41. Patent 12036194 expires

    Listed method-of-use patent (U-3693) expiration.

    Dec 30, 2042

    in 16 yr 9 mo

  42. Patent 12064411 expires

    Listed method-of-use patent (U-3693) expiration.

    Dec 30, 2042

    in 16 yr 9 mo

  43. Patent 12090126 expires

    Listed method-of-use patent (U-3693) expiration.

    Dec 30, 2042

    in 16 yr 9 mo

  44. Patent 12102609 expires

    Listed method-of-use patent (U-3693) expiration.

    Dec 30, 2042

    in 16 yr 9 mo

  45. Patent 12263145 expires

    Listed method-of-use patent (U-3693) expiration.

    Dec 30, 2042

    in 16 yr 9 mo

Pharmaceutical detail

Active ingredient

SOLRIAMFETOL HYDROCHLORIDE

Strength

EQ 75MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 211230

Product number

001

Marketing status

RX

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 (1)

  • ODE-254Orphan-drug exclusivity (7 years)

    Jun 17, 2026

    2 d ago

Listed patents (42)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10351517Jun 07, 202612 d ago
U-2548
11753368Jun 07, 202612 d ago
U-2548
12209059Jun 07, 202612 d ago
U-2548
8877806Jun 07, 202612 d ago
U-2548
9604917Jun 07, 202612 d ago
U-2548
8440715Jun 11, 2031in 5 yr 1 mo
U-2548
10195151Sep 05, 2037in 11 yr 5 mo
Product
10512609Sep 05, 2037in 11 yr 5 mo
U-2548
11439597Sep 05, 2037in 11 yr 5 mo
Product
11998639Sep 05, 2037in 11 yr 5 mo
ProductU-2548
12390419Sep 05, 2037in 11 yr 5 mo
ProductU-2548
10912754Jun 01, 2038in 12 yr 2 mo
U-3082
10959976Jun 01, 2038in 12 yr 2 mo
U-3151
11648232Jun 01, 2038in 12 yr 2 mo
U-3602
11865098Jun 01, 2038in 12 yr 2 mo
U-2548
12384743Nov 01, 2038in 12 yr 7 mo
SubstanceProductU-2548
11560354Mar 06, 2039in 12 yr 11 mo
ProductU-3520
10940133Mar 19, 2040in 13 yr 11 mo
U-3099
11160779Mar 19, 2040in 13 yr 11 mo
U-3521
11839598Mar 19, 2040in 13 yr 11 mo
U-3765
11839599Mar 19, 2040in 13 yr 11 mo
U-3764
11850226Mar 19, 2040in 13 yr 11 mo
U-3775
11850227Mar 19, 2040in 13 yr 11 mo
U-3775
11850228Mar 19, 2040in 13 yr 11 mo
U-3775
11857528Mar 19, 2040in 13 yr 11 mo
U-3521
11969404Mar 19, 2040in 13 yr 11 mo
U-3892
11986454Mar 19, 2040in 13 yr 11 mo
U-3775
11986455Mar 19, 2040in 13 yr 11 mo
U-3521
12194016Mar 19, 2040in 13 yr 11 mo
U-4106
12318362Mar 19, 2040in 13 yr 11 mo
U-3765
11771666Dec 30, 2042in 16 yr 9 mo
U-3693
11771667Dec 30, 2042in 16 yr 9 mo
U-3693
11779554Dec 30, 2042in 16 yr 9 mo
U-3693
11793776Dec 30, 2042in 16 yr 9 mo
U-3693
11872203Dec 30, 2042in 16 yr 9 mo
U-3693
11872204Dec 30, 2042in 16 yr 9 mo
U-3693
12005036Dec 30, 2042in 16 yr 9 mo
U-3693
12036194Dec 30, 2042in 16 yr 9 mo
U-3693
12064411Dec 30, 2042in 16 yr 9 mo
U-3693
12090126Dec 30, 2042in 16 yr 9 mo
U-3693
12102609Dec 30, 2042in 16 yr 9 mo
U-3693
12263145Dec 30, 2042in 16 yr 9 mo
U-3693
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