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 fifteen 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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Summary for AUSTEDO
| International Patents: | 124 |
| US Patents: | 14 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 4 |
| Patent Applications: | 17 |
| 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 Loss of Exclusivity (LOE) Date for AUSTEDO
*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 |
|---|---|
| Teva Branded Pharmaceutical Products R&D, Inc. | Phase 2/Phase 3 |
| Vanderbilt University Medical Center | Phase 2/Phase 3 |
| Fundacion Huntington Puerto Rico | Phase 1 |
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 fourteen 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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
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 | AUSTEDO XR | deutetrabenazine | TABLET, EXTENDED RELEASE;ORAL | 216354-003 | Feb 17, 2023 | RX | Yes | Yes | ⤷ 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 | Y | ⤷ Sign Up | |||
| Teva | AUSTEDO XR | deutetrabenazine | TABLET, EXTENDED RELEASE;ORAL | 216354-008 | Jul 1, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 |
|---|---|---|---|
| Hong Kong | 1212232 | 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) | ⤷ Sign Up |
| Hungary | E038158 | ⤷ Sign Up | |
| Israel | 305352 | שיטות לטיפול בהפרעות תנועה לא נורמליות (Methods for the treatment of abnormal involuntary movement disorders) | ⤷ Sign Up |
| Hong Kong | 1249860 | 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 | 2019059784 | 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) | ⤷ 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.
ISSN: 2162-2639
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