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 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
Summary for AUSTEDO
International Patents: | 124 |
US Patents: | 13 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 4 |
Patent Applications: | 17 |
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 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
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 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
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 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 | ||||
>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: ⤷ Sign Up
Patent: 18222896
Estimated Expiration: ⤷ Sign Up
Patent: 20205297
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2015005894
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 83641
Estimated Expiration: ⤷ Sign Up
Patent: 24804
Estimated Expiration: ⤷ Sign Up
China
Patent: 4684555
Estimated Expiration: ⤷ Sign Up
Patent: 1728971
Estimated Expiration: ⤷ Sign Up
Patent: 6768882
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 97615
Estimated Expiration: ⤷ Sign Up
Patent: 45100
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 12232
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
Estimated Expiration: ⤷ Sign Up
Patent: 18162287
Estimated Expiration: ⤷ Sign Up
Patent: 19059784
Estimated Expiration: ⤷ Sign Up
Patent: 20189871
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5372
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 |
---|---|---|---|
Japan | 2018162287 | 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) | ⤷ Sign Up |
European Patent Office | 4345100 | FORMULATIONS PHARMACOCINÉTIQUES D'INHIBITEURS DE BENZOQUINOLINE DEUTÉRÉS DU TRANSPORTEUR VÉSICULAIRE DE MONOAMINE 2 (FORMULATIONS PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2) | ⤷ Sign Up |
Taiwan | I772382 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |