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  1. pharmadog
  2. ›drugs
  3. ›Sunosi
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solriamfetol hydrochloride

Marketedupdated 5mo ago
by $AXSM Axsome Therapeutics, Inc.
Approved
community read0 votes

all catalysts(0)

nothing on the calendar yet

Trials studying solriamfetol hydrochloride

  • —SUNOSI® (Solriamfetol) Pregnancy Registryrecruitingn=1,731

Patent cliff

source: FDA Orange Book
first barrier falls
Jun 11, 2031
~4.7 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (81)

  • Dec 30, 2042method-of-use (U-3693)US 11771666
  • Dec 30, 2042method-of-use (U-3693)US 11771666
  • Dec 30, 2042method-of-use (U-3693)US 11771667
  • Dec 30, 2042method-of-use (U-3693)US 11771667
  • Dec 30, 2042method-of-use (U-3693)US 11779554
  • Dec 30, 2042method-of-use (U-3693)US 11779554
  • Dec 30, 2042method-of-use (U-3693)US 11793776
  • Dec 30, 2042method-of-use (U-3693)US 11793776
  • Dec 30, 2042method-of-use (U-3693)US 11872203
  • Dec 30, 2042method-of-use (U-3693)US 11872203
  • Dec 30, 2042method-of-use (U-3693)US 11872204
  • Dec 30, 2042method-of-use (U-3693)US 11872204
  • Dec 30, 2042method-of-use (U-3693)US 12005036
  • Dec 30, 2042method-of-use (U-3693)US 12005036
  • Dec 30, 2042method-of-use (U-3693)US 12036194
  • Dec 30, 2042method-of-use (U-3693)US 12036194
  • Dec 30, 2042method-of-use (U-3693)US 12064411
  • Dec 30, 2042method-of-use (U-3693)US 12064411
  • Dec 30, 2042method-of-use (U-3693)US 12090126
  • Dec 30, 2042method-of-use (U-3693)US 12090126
  • Dec 30, 2042method-of-use (U-3693)US 12102609
  • Dec 30, 2042method-of-use (U-3693)US 12102609
  • Dec 30, 2042method-of-use (U-3693)US 12263145
  • Mar 19, 2040method-of-use (U-3099)US 10940133
  • Mar 19, 2040method-of-use (U-3521)US 11160779
  • Mar 19, 2040method-of-use (U-3521)US 11160779
  • Mar 19, 2040method-of-use (U-3765)US 11839598
  • Mar 19, 2040method-of-use (U-3765)US 11839598
  • Mar 19, 2040method-of-use (U-3764)US 11839599
  • Mar 19, 2040method-of-use (U-3764)US 11839599
  • Mar 19, 2040method-of-use (U-3775)US 11850226
  • Mar 19, 2040method-of-use (U-3775)US 11850226
  • Mar 19, 2040method-of-use (U-3775)US 11850227
  • Mar 19, 2040method-of-use (U-3775)US 11850227
  • Mar 19, 2040method-of-use (U-3775)US 11850228
  • Mar 19, 2040method-of-use (U-3775)US 11850228
  • Mar 19, 2040method-of-use (U-3521)US 11857528
  • Mar 19, 2040method-of-use (U-3521)US 11857528
  • Mar 19, 2040method-of-use (U-3892)US 11969404
  • Mar 19, 2040method-of-use (U-3892)US 11969404
  • Mar 19, 2040method-of-use (U-3775)US 11986454
  • Mar 19, 2040method-of-use (U-3775)US 11986454
  • Mar 19, 2040method-of-use (U-3521)US 11986455
  • Mar 19, 2040method-of-use (U-3521)US 11986455
  • Mar 19, 2040method-of-use (U-4106)US 12194016
  • Mar 19, 2040method-of-use (U-4106)US 12194016
  • Mar 19, 2040method-of-use (U-3765)US 12318362
  • Mar 6, 2039formulationUS 11560354
  • Mar 6, 2039formulationUS 11560354
  • Nov 1, 2038compositionUS 12384743
  • Nov 1, 2038compositionUS 12384743
  • Jun 1, 2038method-of-use (U-3082)US 10912754
  • Jun 1, 2038method-of-use (U-3082)US 10912754
  • Jun 1, 2038method-of-use (U-3151)US 10959976
  • Jun 1, 2038method-of-use (U-3151)US 10959976
  • Jun 1, 2038method-of-use (U-3602)US 11648232
  • Jun 1, 2038method-of-use (U-3602)US 11648232
  • Jun 1, 2038method-of-use (U-2548)US 11865098
  • Jun 1, 2038method-of-use (U-2548)US 11865098
  • Sep 5, 2037formulationUS 10195151
  • Sep 5, 2037formulationUS 10195151
  • Sep 5, 2037method-of-use (U-2548)US 10512609
  • Sep 5, 2037method-of-use (U-2548)US 10512609
  • Sep 5, 2037formulationUS 11439597
  • Sep 5, 2037formulationUS 11439597
  • Sep 5, 2037formulationUS 11998639
  • Sep 5, 2037formulationUS 11998639
  • Sep 5, 2037formulationUS 12390419
  • Sep 5, 2037formulationUS 12390419
  • Jun 11, 2031method-of-use (U-2548)US 84407154.7y
  • Jun 11, 2031method-of-use (U-2548)US 84407154.7y
  • Jun 7, 2026method-of-use (U-2548)US 10351517
  • Jun 7, 2026method-of-use (U-2548)US 10351517
  • Jun 7, 2026method-of-use (U-2548)US 11753368
  • Jun 7, 2026method-of-use (U-2548)US 11753368
  • Jun 7, 2026method-of-use (U-2548)US 12209059
  • Jun 7, 2026method-of-use (U-2548)US 12209059
  • Jun 7, 2026method-of-use (U-2548)US 8877806
  • Jun 7, 2026method-of-use (U-2548)US 8877806
  • Jun 7, 2026method-of-use (U-2548)US 9604917
  • Jun 7, 2026method-of-use (U-2548)US 9604917

FDA exclusivities (2)

  • Jun 17, 2026ODE-254Orphan Drug (7y)
  • Jun 17, 2026ODE-254Orphan Drug (7y)

News(4)

  • SK pens $315M pact with fellow South Korean company for Parkinson’s prospect
    SK Biopharmaceuticals has added a second preclinical Parkinson’s disease therapy to its pipeline courtesy of a $314.8 million biobucks deal with a fellow South Korean drug developer.
    fiercebiotech · 18d ago
  • Takeda leads wave of orexin drugs with potential to upend narcolepsy market
    The FDA’s August approval of Takeda’s Orzeyful for treating the full set of narcolepsy symptoms initiated a new era in the sleep market.
    biospace · 1mo ago
  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    biopharma_dive · 4mo ago
  • Axsome pushes back generic entry for narcolepsy drug until 2040
    Axsome Therapeutics has successfully delayed generic competition for its narcolepsy drug Sunosi until 2040. The company announced on Wednesday that it has reached a settlement with the last applica…
    endpoints · 4mo ago
brand
Sunosi
generic
solriamfetol hydrochloride
indication
Obstructive Sleep Apnea
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 2h ago
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