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Last Updated: May 27, 2022

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

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Drug patent expirations by year for AUSTEDO
Drug Prices for AUSTEDO

See drug prices for AUSTEDO

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

SponsorPhase
Vanderbilt University Medical CenterPhase 2/Phase 3
Teva Branded Pharmaceutical Products R&D, Inc.Phase 2/Phase 3
Fundacion Huntington Puerto RicoPhase 1

See all AUSTEDO clinical trials

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-003 Apr 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-003 Apr 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-003 Apr 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-003 Apr 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-001 Apr 3, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-002 Apr 3, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-002 Apr 3, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
McKinsey
Express Scripts
Johnson and Johnson
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.