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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

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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:	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

Drug patent expirations by year for AUSTEDO

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

Generic Entry Date for AUSTEDO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
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 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.

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

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

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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	216354-002	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
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-003	Apr 3, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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
>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.

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Country	Patent Number	Title	Estimated Expiration
Japan	6362601		⤷ Sign Up
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)	⤷ Sign Up
China	102186848	Benzoquinoline inhibitors of vesicular monoamine transporter 2	⤷ Sign Up
Hong Kong	1212232	氘化苯並喹啉的囊泡單胺轉運體抑制劑的配方藥代動力學 (FORMULATIONS PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER)	⤷ Sign Up
Israel	305352	שיטות לטיפול בהפרעות תנועה לא נורמליות (Methods for the treatment of abnormal involuntary movement disorders)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration