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AUSTEDO Drug Patent Profile

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 nineteen 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:	119
US Patents:	13
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	4
Patent Applications:	18
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

See drug prices for AUSTEDO

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

NDA:

208082

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
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

See all AUSTEDO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for AUSTEDO

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

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.

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

FDA Regulatory Exclusivity protecting AUSTEDO

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					Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-003	Apr 3, 2017		RX	Yes	Yes					Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-002	Apr 3, 2017		RX	Yes	No
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-003	Apr 3, 2017		RX	Yes	Yes
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-001	Feb 17, 2023		RX	Yes	No					Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-003	Apr 3, 2017		RX	Yes	Yes					Y

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

Brazil

Canada

China

European Patent Office

Hong Kong

India

Japan

New Zealand

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
China	114767672	氘代丁苯那嗪或包含氘代丁苯那嗪的组合物 (Deuterated tetrabenazine or composition containing deuterated tetrabenazine)
Poland	3265085
Japan	2020189871	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)
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)
European Patent Office	2610254	DÉRIVÉS DEUTÉRÉS DE BENZOQUINOLINE EN TANT QU'INHIBITEURS DU TRANSPORTEUR DE MONOAMINE VÉSICULAIRE 2 (DEUTERATED BENZOQUINOLINE DERIVATIVES AS INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2)
Norway	3061760