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Last Updated: July 18, 2024

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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 Teva and is included in two NDAs. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-four patent family members in thirty-three 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

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 thirteen US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AUSTEDO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Analogs of deutetrabenazine, their preparation and use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods for the treatment of abnormal involuntary movement disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


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Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting AUSTEDO

TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTON'S DISEASE
Exclusivity Expiration: ⤷  Sign Up

INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva AUSTEDO XR deutetrabenazine TABLET, EXTENDED RELEASE;ORAL 216354-002 Feb 17, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-003 Apr 3, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-002 Apr 3, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-003 Apr 3, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Patent: Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Estimated Expiration: ⤷  Sign Up

Patent: 18222896
Patent: Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Estimated Expiration: ⤷  Sign Up

Patent: 20205297
Patent: Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2015005894
Patent: composição farmacêutica
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 83641
Patent: PHARMACOCINETIQUES DE FORMULATIONS D'INHIBITEURS DE BENZOQUINOLINE DEUTERE DU TRANSPORTEUR 2 DE MONOAMINE VESICULAIRE (FORMULATIONS PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2)
Estimated Expiration: ⤷  Sign Up

Patent: 24804
Patent: PHARMACOCINETIQUES DE FORMULATIONS D'INHIBITEURS DE BENZOQUINOLINE DEUTERE DU TRANSPORTEUR 2 DE MONOAMINE VESICULAIRE (FORMULATIONS PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2)
Estimated Expiration: ⤷  Sign Up

China

Patent: 4684555
Patent: Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Estimated Expiration: ⤷  Sign Up

Patent: 1728971
Patent: D6-tetraphenylquinolizine solid oral dosage form, compound, and pharmaceutical composition, preparation method and treatment method thereof
Estimated Expiration: ⤷  Sign Up

Patent: 6768882
Patent: 化合物、及其药物组合物及治疗方法 (Compounds, pharmaceutical compositions and methods of treatment thereof)
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 97615
Patent: PHARMACOCINÉTIQUES DE FORMULATIONS D'INHIBITEURS DE BENZOQUINOLINE DEUTÉRÉ DU TRANSPORTEUR 2 DE MONOAMINE VÉSICULAIRE (FORMULATIONS PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2)
Estimated Expiration: ⤷  Sign Up

Patent: 45100
Patent: FORMULATIONS PHARMACOCINÉTIQUES D'INHIBITEURS DE BENZOQUINOLINE DEUTÉRÉS DU TRANSPORTEUR VÉSICULAIRE DE MONOAMINE 2 (FORMULATIONS PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 12232
Patent: 氘化苯並喹啉的囊泡單胺轉運體 抑制劑的配方藥代動力學 (FORMULATIONS PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER)
Estimated Expiration: ⤷  Sign Up

India

Patent: 62DEN2015
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 62601
Estimated Expiration: ⤷  Sign Up

Patent: 12420
Estimated Expiration: ⤷  Sign Up

Patent: 15528516
Patent: 小胞モノアミン輸送体2の重水素化ベンゾキノリン阻害剤の製剤薬物動態
Estimated Expiration: ⤷  Sign Up

Patent: 18162287
Patent: 小胞モノアミン輸送体2の重水素化ベンゾキノリン阻害剤の製剤薬物動態 (PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2)
Estimated Expiration: ⤷  Sign Up

Patent: 19059784
Patent: 小胞モノアミン輸送体2の重水素化ベンゾキノリン阻害剤の製剤薬物動態 (PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VASCULAR MONOAMINE TRANSPORTER 2)
Estimated Expiration: ⤷  Sign Up

Patent: 20189871
Patent: 小胞モノアミン輸送体2の重水素化ベンゾキノリン阻害剤の製剤薬物動態 (FORMULATION PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 5372
Patent: Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Estimated Expiration: ⤷  Sign Up

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
Peru 20191819 ANALOGOS DE DEUTETRABENAZINA, SU PREPARACION Y USO ⤷  Sign Up
Slovenia 3061760 ⤷  Sign Up
Hong Kong 1248609 用於治療異常不自主運動障礙的方法 (METHODS FOR THE TREATMENT OF ABNORMAL INVOLUNTARY MOVEMENT DISORDERS) ⤷  Sign Up
Japan 6612420 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.