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Last Updated: March 28, 2024

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AUSTEDO Drug Patent Profile


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Which patents cover Austedo, 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 nineteen 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

See drug prices for AUSTEDO

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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Analogs of deutetrabenazine, their preparation and use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods for the treatment of abnormal involuntary movement disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting AUSTEDO

TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTON'S DISEASE
Exclusivity Expiration: ⤷  Try a Trial

INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-003 Apr 3, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-002 Apr 3, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Patent: 18222896
Estimated Expiration: ⤷  Try a Trial

Patent: 20205297
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2015005894
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 83641
Estimated Expiration: ⤷  Try a Trial

Patent: 24804
Estimated Expiration: ⤷  Try a Trial

China

Patent: 4684555
Estimated Expiration: ⤷  Try a Trial

Patent: 1728971
Estimated Expiration: ⤷  Try a Trial

Patent: 6768882
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 97615
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 12232
Estimated Expiration: ⤷  Try a Trial

India

Patent: 62DEN2015
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 62601
Estimated Expiration: ⤷  Try a Trial

Patent: 12420
Estimated Expiration: ⤷  Try a Trial

Patent: 15528516
Estimated Expiration: ⤷  Try a Trial

Patent: 18162287
Estimated Expiration: ⤷  Try a Trial

Patent: 19059784
Estimated Expiration: ⤷  Try a Trial

Patent: 20189871
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 5372
Estimated Expiration: ⤷  Try a Trial

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
South Korea 102335744 ⤷  Try a Trial
European Patent Office 3345905 DÉRIVÉS DEUTÉRÉS DE BENZOQUINOLIZINE EN TANT QU'INHIBITEURS DU TRANSPORTEUR DE MONOAMINE VÉSICULAIRE 2 (DEUTERATED BENZOQUINOLIZINE DERIVATIVES AS INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2) ⤷  Try a Trial
Japan 2021183630 異常不随意運動障害の処置のための方法 (METHODS FOR THE TREATMENT OF ABNORMAL INVOLUNTARY MOVEMENT DISORDERS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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