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Serving hundreds of leading biopharmaceutical companies globally:

Covington
AstraZeneca
Daiichi Sankyo
Julphar
Baxter
Teva
Deloitte
Queensland Health
Express Scripts

Generated: July 21, 2018

DrugPatentWatch Database Preview

AUSTEDO Drug Profile

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Which patents cover Austedo, and what generic alternatives are available?

Austedo is a drug marketed by Teva Branded Pharm and is included in one NDA. There are five patents protecting this drug.

This drug has twenty-nine patent family members in eleven countries.

The generic ingredient in AUSTEDO is deutetrabenazine. One supplier is listed for this compound. Additional details are available on the deutetrabenazine profile page.
Summary for AUSTEDO
International Patents:29
US Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 9
Patent Applications: 8
DailyMed Link:AUSTEDO at DailyMed
Drug patent expirations by year for AUSTEDO
Generic Entry Opportunity 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.

Synonyms for AUSTEDO
(3R,11bR)-3-(2-methylpropyl)-9,10-bis(trideuteriomethoxy)-1,3,4,6,7,11b-hexahydrobenzo[a]quinolizin-2-one
(3RS,11Brs)-9,10-di((2H3)methoxy)-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2H-benzo(a)quinolizin-2-one
[2H6]-(+)-Tetrabenazine|||[2H6]-(+)- 9,10-Dimethoxy-1,3R,4,6,7,11bR-hexahydro-3-isobutyl-2H-benzo[a]quinolizin-2-one
1392826-25-3
2H-Benzo(a)quinolizin-2-one, 1,3,4,6,7,11b-hexahydro-9,10-di(methoxy-d3)-3-(2-methylpropyl)-, (3R,11bR)-rel-
CHEMBL3137326
D10701
DB12161
Deutetrabenazine
Deutetrabenazine (USAN/INN)
Deutetrabenazine [USAN:INN]
Dutetrabenazine
GTPL8707
HY-B0590S
Ro 1-9569 D6
SCHEMBL13321841
SCHEMBL16227993
SCHEMBL16228022
SD 809
SD-809
SD809
Tetrabenazine D6
UNII-P341G6W9NB component MKJIEFSOBYUXJB-VFJJUKLQSA-N
UNII-P341G6W9NB component MKJIEFSOBYUXJB-WEZHFFAMSA-N

US Patents and Regulatory Information for AUSTEDO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-001 Apr 3, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y 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 Y ➤ Sign Up
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-001 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

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Non-Orange Book US Patents for AUSTEDO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,346,800 Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Farmers Insurance
Merck
McKesson
Citi
US Department of Justice
Colorcon
Deloitte
Chinese Patent Office

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 verifification 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.