AUSTEDO XR Drug Patent Profile
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When do Austedo Xr patents expire, and what generic alternatives are available?
Austedo Xr is a drug marketed by Teva and is included in one NDA. There are ten patents protecting this drug.
This drug has one hundred and forty-seven patent family members in thirty-four countries.
The generic ingredient in AUSTEDO XR is deutetrabenazine. One supplier is listed for this compound. Additional details are available on the deutetrabenazine profile page.
DrugPatentWatch® Generic Entry Outlook for Austedo Xr
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.
Indicators of Generic Entry
Summary for AUSTEDO XR
| International Patents: | 147 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 4 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AUSTEDO XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AUSTEDO XR |
| DailyMed Link: | AUSTEDO XR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AUSTEDO XR
*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 XR
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 |
Anatomical Therapeutic Chemical (ATC) Classes for AUSTEDO XR
US Patents and Regulatory Information for AUSTEDO XR
AUSTEDO XR is protected by eleven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AUSTEDO XR 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 XR
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
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
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
| 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 | 216354-003 | Feb 17, 2023 | RX | Yes | Yes | ⤷ 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 | AUSTEDO XR | deutetrabenazine | TABLET, EXTENDED RELEASE;ORAL | 216354-003 | Feb 17, 2023 | RX | Yes | Yes | ⤷ 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 | AUSTEDO XR | deutetrabenazine | TABLET, EXTENDED RELEASE;ORAL | 216354-001 | Feb 17, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Teva | AUSTEDO XR | deutetrabenazine | TABLET, EXTENDED RELEASE;ORAL | 216354-002 | Feb 17, 2023 | 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 XR
When does loss-of-exclusivity occur for AUSTEDO XR?
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
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 XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| 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) | ⤷ Sign Up |
| Denmark | 2326643 | ⤷ Sign Up | |
| Israel | 305352 | שיטות לטיפול בהפרעות תנועה לא נורמליות (Methods for the treatment of abnormal involuntary movement disorders) | ⤷ Sign Up |
| Japan | 2020510073 | デューテトラベナジンの類似体、その調製及び使用 | ⤷ Sign Up |
| Norway | 3061760 | ⤷ Sign Up | |
| Taiwan | 202214246 | Osmotic dosage forms comprising DEUTETRABENAZINE and methods of use thereof | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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