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  1. pharmadog
  2. ›drugs
  3. ›Hetlioz
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tasimelteon

Marketedupdated 3mo ago
by $VNDA Vanda Pharmaceuticals Inc.
Approved
community read0 votes

all catalysts(0)

nothing on the calendar yet

Trials studying tasimelteon

  • phase3Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)active not recruitingn=70
  • EP1The Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)terminatedn=20
  • phase3Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomniarecruitingn=420
  • phase3Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variantrecruitingn=60
  • phase3Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder in Blind Individuals With No Light Perceptionactive not recruitingn=140
  • phase1Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescentscompletedn=24
  • phase1Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjectscompletedn=48
  • phase3Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbancesunknownn=100
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Dec 1, 2027
~1.3 years out

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

patents (58)

  • Feb 21, 2041method-of-use (U-3003)US 11759446
  • Feb 21, 2041method-of-use (U-3003)US 11759446
  • Dec 11, 2040formulationUS 11202770
  • Dec 11, 2040method-of-use (U-3003)US 12447141
  • Aug 29, 2035method-of-use (U-3003)US 10179119
  • Aug 29, 2035method-of-use (U-3003)US 10179119
  • Aug 29, 2035method-of-use (U-3003)US 11266622
  • Aug 29, 2035method-of-use (U-3003)US 11266622
  • Jul 27, 2035method-of-use (U-3007)US 10376487
  • Jul 27, 2035method-of-use (U-3007)US 10376487
  • Feb 12, 2035compositionUS 10071977
  • Feb 12, 2035compositionUS 10071977
  • Feb 12, 2035compositionUS 10829465
  • Feb 12, 2035compositionUS 10829465
  • Feb 12, 2035compositionUS 11566011
  • Feb 12, 2035compositionUS 11566011
  • Feb 12, 2035compositionUS 11760740
  • Feb 12, 2035compositionUS 11760740
  • Feb 12, 2035compositionUS 12049457
  • Feb 12, 2035compositionUS 12049457
  • Oct 10, 2034method-of-use (U-3007)US 10610511
  • Oct 10, 2034method-of-use (U-2615)US 10610511
  • Oct 10, 2034method-of-use (U-3007)US 11141400
  • Oct 10, 2034method-of-use (U-3007)US 11141400
  • Oct 10, 2034method-of-use (U-3739)US 11786502
  • Oct 10, 2034method-of-use (U-3007)US 11786502
  • May 17, 2034method-of-use (U-3005)US 9730910
  • May 17, 2034method-of-use (U-3005)US 9730910
  • Apr 7, 2033method-of-use (U-3343)US 11918556
  • Apr 7, 2033method-of-use (U-3342)US 11918556
  • Jan 25, 2033method-of-use (U-3006)US 10149829
  • Jan 25, 2033method-of-use (U-3006)US 10149829
  • Jan 25, 2033method-of-use (U-2149)US 10449176
  • Jan 25, 2033method-of-use (U-3009)US 10610510
  • Jan 25, 2033method-of-use (U-2805)US 10610510
  • Jan 25, 2033method-of-use (U-2149)US 10945988
  • Jan 25, 2033method-of-use (U-3107)US 10980770
  • Jan 25, 2033method-of-use (U-3106)US 10980770
  • Jan 25, 2033method-of-use (U-3343)US 11285129
  • Jan 25, 2033method-of-use (U-3342)US 11285129
  • Jan 25, 2033method-of-use (U-3003)US 11633377
  • Jan 25, 2033method-of-use (U-3003)US 11633377
  • Jan 25, 2033method-of-use (U-3343)US 11826339
  • Jan 25, 2033method-of-use (U-3342)US 11826339
  • Jan 25, 2033method-of-use (U-3003)US 11833130
  • Jan 25, 2033method-of-use (U-3003)US 11833130
  • Jan 25, 2033method-of-use (U-3343)US 11850229
  • Jan 25, 2033method-of-use (U-3342)US 11850229
  • Jan 25, 2033method-of-use (U-3003)US 11918557
  • Jan 25, 2033method-of-use (U-3865)US 11918557
  • Jan 25, 2033method-of-use (U-3865)US 12201604
  • Jan 25, 2033method-of-use (U-3003)US 12201604
  • Jan 25, 2033method-of-use (U-1710)US 9060995
  • Jan 25, 2033method-of-use (U-3004)US 9539234
  • Jan 25, 2033method-of-use (U-3004)US 9539234
  • Jan 25, 2033method-of-use (U-1486)US 9549913
  • Jan 25, 2033method-of-use (U-2149)US 9855241
  • Jan 25, 2033method-of-use (U-2147)US RE46604

FDA exclusivities (2)

  • Dec 1, 2027ODE-330Orphan Drug (7y)1.3y
  • Dec 1, 2027ODE-329Orphan Drug (7y)1.3y

News(0)

no news has mentioned this drug yet

brand
Hetlioz
generic
tasimelteon
indication
Circadian Rhythm Sleep Disorders
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 38m ago
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