Austedo
(Deutetrabenazine)ApprovedSmall molecule
TevaThis medication is used to reduce involuntary movements (like sudden jerking or twisting motions) caused by Huntington's disease and a movement disorder called tardive dyskinesia. It works by adjusting brain chemicals that control nerve and muscle activity.[2] Austedo is currently approved and in use across 4 indications[4].[1]
Austedo is one of 70 small molecule programs targeting Dysphagia. It is currently in Approved.
4
Indications
5
Total Trials
2
Active Trials
69
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
31
Patents
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
34 competitors in Huntington Disease
#DrugCompanyPhaseTrials
1Actigall
AbbVieApproved
Dojolvi
UltragenyxApproved
Epidiolex
Jazz PharmaceuticalsApproved
Glucophage
EMD SeronoApproved
Tricor
JJagotec
Approved
Haldol
DDePuy Orthopaedics
Approved
Lithobid
SSolvay Pharmaceuticals
Approved
Tasigna
AAzurity Pharmaceuticals
Approved
Risperdal
WWim Janssens
Approved
Acetadote
AArbor Pharmaceuticals, Inc.
Approved
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Dystonia1 trial
Huntington's Disease1 trial
Symptomatic Therapy for Patients With Huntington's Disease
Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 1·NCT04071639·60 enrolled
Huntington disease1 trial
Tardive Dyskinesia1 trial
Regulatory
FDA Approval Timeline[5]
Apr 3, 2017
AUSTEDO
NDA NDA208082
Feb 17, 2023
AUSTEDO XR
NDA NDA216354
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Austedo drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Deutetrabenazine. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Patent Landscape[6]
Patent Cliff
Apr 3, 2031
Earliest patent expiration — generic entry possible after this date
Patent #Expires
8524733Apr 3, 2031
8524733*PEDOct 3, 2031
9233959Sep 18, 2033
9296739Sep 18, 2033
9814708Sep 18, 2033
26 more patents
11666566Sep 18, 2033
9550780Sep 18, 2033
9233959*PEDMar 18, 2034
9296739*PEDMar 18, 2034
9550780*PEDMar 18, 2034
9814708*PEDMar 18, 2034
11666566*PEDMar 18, 2034
11648244Mar 7, 2036
11446291Mar 7, 2036
11357772Mar 7, 2036
11564917Mar 7, 2036
10959996Mar 7, 2036
12016858Mar 7, 2036
12016858*PEDSep 7, 2036
10959996*PEDSep 7, 2036
11564917*PEDSep 7, 2036
11648244*PEDSep 7, 2036
11446291*PEDSep 7, 2036
11357772*PEDSep 7, 2036
11179386Mar 15, 2038
11813232Mar 15, 2038
11813232*PEDSep 15, 2038
11179386*PEDSep 15, 2038
12599598Jun 10, 2041
11311488Jun 10, 2041
12589075Jun 10, 2041