AUSTEDO Drug Patent Profile
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When do Austedo patents expire, and when can generic versions of Austedo launch?
Austedo is a drug marketed by Teva Branded Pharm and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has ninety-four patent family members in thirty-one countries.
The generic ingredient in AUSTEDO is deutetrabenazine. One supplier is listed for this compound. Additional details are available on the deutetrabenazine profile page.
DrugPatentWatch® Generic Entry Outlook for Austedo
Austedo was eligible for patent challenges on April 3, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 18, 2034. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for AUSTEDO
International Patents: | 94 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 22 |
Clinical Trials: | 4 |
Patent Applications: | 85 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for AUSTEDO |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AUSTEDO |
What excipients (inactive ingredients) are in AUSTEDO? | AUSTEDO excipients list |
DailyMed Link: | AUSTEDO at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for AUSTEDO
Generic Entry Date for AUSTEDO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for AUSTEDO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Vanderbilt University Medical Center | Phase 2/Phase 3 |
Teva Branded Pharmaceutical Products R&D, Inc. | Phase 2/Phase 3 |
Fundacion Huntington Puerto Rico | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for AUSTEDO
Paragraph IV (Patent) Challenges for AUSTEDO
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AUSTEDO | Tablets | deutetrabenazine | 6 mg, 9 mg and 12 mg | 208082 | 2 | 2021-04-05 |
US Patents and Regulatory Information for AUSTEDO
AUSTEDO is protected by seven US patents and six FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AUSTEDO is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting AUSTEDO
Methods for the treatment of abnormal involuntary movement disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Analogs of deutetrabenazine, their preparation and use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting AUSTEDO
TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTON'S DISEASE
Exclusivity Expiration: See Plans and Pricing
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
Exclusivity Expiration: See Plans and Pricing
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing
International Patents for AUSTEDO
When does loss-of-exclusivity occur for AUSTEDO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 13318182
Estimated Expiration: See Plans and Pricing
Patent: 18222896
Estimated Expiration: See Plans and Pricing
Patent: 20205297
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2015005894
Estimated Expiration: See Plans and Pricing
Canada
Patent: 83641
Estimated Expiration: See Plans and Pricing
Patent: 24804
Estimated Expiration: See Plans and Pricing
China
Patent: 4684555
Estimated Expiration: See Plans and Pricing
Patent: 1728971
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 97615
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 12232
Estimated Expiration: See Plans and Pricing
India
Patent: 62DEN2015
Estimated Expiration: See Plans and Pricing
Japan
Patent: 62601
Estimated Expiration: See Plans and Pricing
Patent: 12420
Estimated Expiration: See Plans and Pricing
Patent: 15528516
Estimated Expiration: See Plans and Pricing
Patent: 18162287
Estimated Expiration: See Plans and Pricing
Patent: 19059784
Estimated Expiration: See Plans and Pricing
Patent: 20189871
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 5372
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering AUSTEDO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2016144901 | See Plans and Pricing | |
Spain | 2563820 | See Plans and Pricing | |
Eurasian Patent Organization | 201992168 | АНАЛОГИ ДЕУТЕТРАБЕНАЗИНА, ИХ ПОЛУЧЕНИЕ И ПРИМЕНЕНИЕ | See Plans and Pricing |
South Africa | 201706131 | METHODS FOR THE TREATMENT OF ABNORMAL INVOLUNTARY MOVEMENT DISORDERS | See Plans and Pricing |
European Patent Office | 2326643 | INHIBITEURS BENZOQUINOLINE DU TRANSPORTEUR DE MONOAMINES VÉSICULAIRE 2 (BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2) | See Plans and Pricing |
Chile | 2019002629 | Análogos de deutetrabenazina, su preparación y uso. | See Plans and Pricing |
South Korea | 20210149246 | 비정상적 불수의 운동 장애의 치료 방법 (METHODS FOR THE TREATMENT OF ABNORMAL INVOLUNTARY MOVEMENT DISORDERS) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |