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  3. ›Auvelity
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(bupropion hydrochloride + dextromethorphan) ER

Marketedupdated 3mo ago
by $AXSM Axsome Therapeutics, Inc.
Approved
community read0 votes

🐶 often sniffed alongside

top 8
  • drugAUVELITY7 co-mentions · 4 sources
  • tagApproval6 co-mentions · 3 sources
  • drugbupropion hydrochloride ER4 co-mentions · 4 sources
  • drugWELLBUTRIN SR4 co-mentions · 4 sources
  • drugWELLBUTRIN4 co-mentions · 4 sources
  • drugbupropion4 co-mentions · 4 sources
  • drugBUPROPION HYDROCHLORIDE4 co-mentions · 4 sources
  • drugbupropion hydrochloride MR4 co-mentions · 4 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 7 investigational indications.

indications

investigational
Major Depression

all catalysts(4)

approval · 3
Aug 18, 2022
approval
$AXSM213.67-0.00%
4y ago
AUVELITY (BUPROPION HYDROCHLORIDE) — FDA approval
(bupropion hydrochloride + dextromethorphan) ER
→
May 7, 2024
approval
$AXSM213.67-0.00%
2y ago
AUVELITY (BUPROPION HYDROCHLORIDE) — FDA approval
(bupropion hydrochloride + dextromethorphan) ER
→
Nov 5, 2025
approval
$AXSM213.67-0.00%
9mo ago
AUVELITY (BUPROPION HYDROCHLORIDE) — FDA approval
(bupropion hydrochloride + dextromethorphan) ER
→
pdufa · 1
Apr 30, 2026
pdufa
$AXSM213.67-0.00%
4mo ago
Axsome Therapeutics Inc — (bupropion hydrochloride + dextromethorphan) ER (PDUFA)
(bupropion hydrochloride + dextromethorphan) ER
→

Patent cliff

source: FDA Orange Book
first barrier falls
Oct 29, 2033
~7.2 years out

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

patents (130)

  • Apr 20, 2043method-of-use (U-3778)US 11844797
  • Mar 2, 2043method-of-use (U-3419)US 11839612
  • Feb 23, 2043method-of-use (U-3419)US 11752144
  • Feb 23, 2043method-of-use (U-3419)US 12042473
  • Feb 23, 2043method-of-use (U-3419)US 12146889
  • Feb 15, 2043method-of-use (U-3419)US 11986444
  • Feb 15, 2043method-of-use (U-3419)US 12036191
  • Jan 23, 2043method-of-use (U-3419)US 11730706
  • Jan 23, 2043method-of-use (U-3419)US 11883373
  • Jan 20, 2043method-of-use (U-3419)US 11717518
  • Jan 20, 2043method-of-use (U-3419)US 11925636
  • Jan 20, 2043formulationUS 12156914
  • Jan 20, 2043method-of-use (U-3419)US 12310961
  • Jan 20, 2043method-of-use (U-3419)US 12357697
  • Dec 1, 2041method-of-use (U-3419)US 11896563
  • Dec 1, 2041method-of-use (U-3419)US 12390428
  • Jan 7, 2040method-of-use (U-3419)US 10780064
  • Jan 7, 2040method-of-use (U-3419)US 10925842
  • Jan 7, 2040method-of-use (U-3419)US 10940124
  • Jan 7, 2040method-of-use (U-3419)US 10966942
  • Nov 9, 2034method-of-use (U-3419)US 10780066
  • Nov 5, 2034method-of-use (U-3419)US 10058518
  • Nov 5, 2034method-of-use (U-3419)US 10064857
  • Nov 5, 2034method-of-use (U-3419)US 10080727
  • Nov 5, 2034method-of-use (U-3419)US 10092560
  • Nov 5, 2034method-of-use (U-3419)US 10092561
  • Nov 5, 2034method-of-use (U-3419)US 10105327
  • Nov 5, 2034method-of-use (U-3419)US 10105361
  • Nov 5, 2034method-of-use (U-3419)US 10251879
  • Nov 5, 2034method-of-use (U-3419)US 10463634
  • Nov 5, 2034method-of-use (U-3419)US 10512643
  • Nov 5, 2034method-of-use (U-3419)US 10548857
  • Nov 5, 2034method-of-use (U-3419)US 10596167
  • Nov 5, 2034method-of-use (U-3419)US 10772850
  • Nov 5, 2034method-of-use (U-3419)US 10786469
  • Nov 5, 2034method-of-use (U-3419)US 10786496
  • Nov 5, 2034method-of-use (U-3419)US 10799497
  • Nov 5, 2034method-of-use (U-3419)US 10806710
  • Nov 5, 2034method-of-use (U-3419)US 10864209
  • Nov 5, 2034method-of-use (U-3419)US 10874663
  • Nov 5, 2034method-of-use (U-3419)US 10874664
  • Nov 5, 2034method-of-use (U-3419)US 10874665
  • Nov 5, 2034method-of-use (U-3419)US 10881624
  • Nov 5, 2034method-of-use (U-3419)US 10881657
  • Nov 5, 2034method-of-use (U-3419)US 10894046
  • Nov 5, 2034method-of-use (U-3419)US 10894047
  • Nov 5, 2034method-of-use (U-3419)US 10898453
  • Nov 5, 2034method-of-use (U-3419)US 10933034
  • Nov 5, 2034method-of-use (U-3419)US 10945973
  • Nov 5, 2034method-of-use (U-3419)US 10966941
  • Nov 5, 2034method-of-use (U-3419)US 10966974
  • Nov 5, 2034method-of-use (U-3419)US 11020389
  • Nov 5, 2034method-of-use (U-3419)US 11058648
  • Nov 5, 2034method-of-use (U-3419)US 11065248
  • Nov 5, 2034method-of-use (U-3419)US 11090300
  • Nov 5, 2034method-of-use (U-3419)US 11096937
  • Nov 5, 2034method-of-use (U-3419)US 11123343
  • Nov 5, 2034method-of-use (U-3419)US 11123344
  • Nov 5, 2034method-of-use (U-3419)US 11129826
  • Nov 5, 2034method-of-use (U-3419)US 11141388
  • Nov 5, 2034method-of-use (U-3419)US 11141416
  • Nov 5, 2034method-of-use (U-3419)US 11147808
  • Nov 5, 2034method-of-use (U-3419)US 11185515
  • Nov 5, 2034formulationUS 11191739
  • Nov 5, 2034formulationUS 11197839
  • Nov 5, 2034method-of-use (U-3419)US 11207281
  • Nov 5, 2034method-of-use (U-3419)US 11213521
  • Nov 5, 2034method-of-use (U-3419)US 11229640
  • Nov 5, 2034method-of-use (U-3419)US 11234946
  • Nov 5, 2034method-of-use (U-3419)US 11253491
  • Nov 5, 2034method-of-use (U-3419)US 11253492
  • Nov 5, 2034method-of-use (U-3419)US 11273133
  • Nov 5, 2034method-of-use (U-3419)US 11273134
  • Nov 5, 2034method-of-use (U-3419)US 11285118
  • Nov 5, 2034method-of-use (U-3419)US 11285146
  • Nov 5, 2034method-of-use (U-3419)US 11291638
  • Nov 5, 2034method-of-use (U-3419)US 11291665
  • Nov 5, 2034method-of-use (U-3419)US 11298351
  • Nov 5, 2034method-of-use (U-3419)US 11298352
  • Nov 5, 2034method-of-use (U-3419)US 11311534
  • Nov 5, 2034method-of-use (U-3419)US 11344544
  • Nov 5, 2034method-of-use (U-3419)US 11357744
  • Nov 5, 2034method-of-use (U-3419)US 11364233
  • Nov 5, 2034method-of-use (U-3419)US 11382874
  • Nov 5, 2034method-of-use (U-3419)US 11419867
  • Nov 5, 2034method-of-use (U-3419)US 11426370
  • Nov 5, 2034method-of-use (U-3419)US 11426401
  • Nov 5, 2034formulationUS 11433067
  • Nov 5, 2034method-of-use (U-3419)US 11439636
  • Nov 5, 2034method-of-use (U-3419)US 11478468
  • Nov 5, 2034method-of-use (U-3419)US 11497721
  • Nov 5, 2034method-of-use (U-3419)US 11510918
  • Nov 5, 2034method-of-use (U-3419)US 11517542
  • Nov 5, 2034method-of-use (U-3419)US 11517543
  • Nov 5, 2034method-of-use (U-3419)US 11524007
  • Nov 5, 2034method-of-use (U-3419)US 11524008
  • Nov 5, 2034formulationUS 11534414
  • Nov 5, 2034method-of-use (U-3419)US 11541021
  • Nov 5, 2034method-of-use (U-3419)US 11541048
  • Nov 5, 2034method-of-use (U-3419)US 11571417
  • Nov 5, 2034method-of-use (U-3419)US 11576909
  • Nov 5, 2034method-of-use (U-3419)US 11590124
  • Nov 5, 2034method-of-use (U-3419)US 11596627
  • Nov 5, 2034method-of-use (U-3419)US 11617728
  • Nov 5, 2034method-of-use (U-3563)US 11617747
  • Nov 5, 2034method-of-use (U-3419)US 11779579
  • Nov 5, 2034method-of-use (U-3419)US 11969421
  • Nov 5, 2034method-of-use (U-3419)US 12109178
  • Nov 5, 2034method-of-use (U-3419)US 9168234
  • Nov 5, 2034method-of-use (U-3419)US 9198905
  • Nov 5, 2034method-of-use (U-3419)US 9205083
  • Nov 5, 2034method-of-use (U-3419)US 9238032
  • Nov 5, 2034method-of-use (U-3419)US 9278095
  • Nov 5, 2034method-of-use (U-3419)US 9314462
  • Nov 5, 2034method-of-use (U-3419)US 9370513
  • Nov 5, 2034method-of-use (U-3419)US 9375429
  • Nov 5, 2034method-of-use (U-3419)US 9408815
  • Nov 5, 2034method-of-use (U-3419)US 9421176
  • Nov 5, 2034method-of-use (U-3419)US 9457023
  • Nov 5, 2034method-of-use (U-3419)US 9457025
  • Nov 5, 2034method-of-use (U-3419)US 9474731
  • Nov 5, 2034method-of-use (U-3419)US 9486450
  • Nov 5, 2034method-of-use (U-3419)US 9700528
  • Nov 5, 2034method-of-use (U-3419)US 9700553
  • Nov 5, 2034method-of-use (U-3419)US 9707191
  • Nov 5, 2034method-of-use (U-3419)US 9763932
  • Nov 5, 2034method-of-use (U-3419)US 9861595
  • Nov 5, 2034method-of-use (U-3419)US 9867819
  • Nov 5, 2034method-of-use (U-3419)US 9968568
  • Oct 29, 2033formulationUS 8569328

News(3)

  • The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
    The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
    biospace · 25d ago
  • Summit’s ‘self-inflicted’ stumble; Esperion’s take-private deal
    Summit’s decision to conduct an interim analysis of a closely watched trial backfired. Elsewhere, Axsome got a much-needed label expansion and an FDA committee sided against an AstraZeneca breast c…
    biopharma_dive · 3mo ago
  • FDA approval for Alzheimer's agitation drug; Esperion goes private in $1.1B deal
    🟢 FDA approves Axsome Therapeutics' Auvelity for Alzheimer’s agitation: Axsome said up to 76% of patients with Alzheimer’s disease have agitation, which is characterized by pacing, restlessness an…
    endpoints · 3mo ago
brand
Auvelity
generic
(bupropion hydrochloride + dextromethorphan [INN])
MOA
12.1 Mechanism of Action Dextromethorphan is an uncompetitive antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. The mechanism of dextromethorphan in the treatment of MDD is unclear. The mechanism of action of bupropion in the treatment of MDD is unclear; however, it may be related to noradrenergic and/or dopaminergic mechanisms. Bupropion increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6, which catalyzes a major biotransformation pathway for dextromethorphan. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.
indication
Dementia Associated With Alzheimer's Disease
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 28m ago
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