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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 thirty-six patent family members in thirty-three 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

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Summary for AUSTEDO XR

International Patents:	136
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

Drug patent expirations by year for AUSTEDO XR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AUSTEDO XR

Generic Entry Date for AUSTEDO XR^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 216354 Dosage: TABLET, EXTENDED RELEASE;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 XR

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

See all AUSTEDO XR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for AUSTEDO XR

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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 ⤷ 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 XR

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

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA

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

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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-003	Feb 17, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-003	Feb 17, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-003	Feb 17, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-001	Feb 17, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ 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 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: ⤷ 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 XR around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2009303758	Benzoquinoline inhibitors of vesicular monoamine transporter 2	⤷ Try a Trial
European Patent Office	2326643	INHIBITEURS BENZOQUINOLINE DU TRANSPORTEUR DE MONOAMINES VÉSICULAIRE 2 (BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2)	⤷ Try a Trial
Eurasian Patent Organization	201791977	СПОСОБЫ ЛЕЧЕНИЯ ПАТОЛОГИЧЕСКИХ НЕПРОИЗВОЛЬНЫХ ДВИЖЕНИЙ	⤷ Try a Trial
South Korea	20170122820	비정상적 불수의 운동 장애의 치료 방법	⤷ Try a Trial
Denmark	2326643		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration