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AUSTEDO Drug Profile

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When do Austedo patents expire, and when can generic versions of Austedo launch?

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 fifty-two patent family members in twenty countries.

The generic ingredient in AUSTEDO is deutetrabenazine. One supplier is listed for this compound. Additional details are available on the deutetrabenazine profile page.

US ANDA Litigation and Generic Entry Outlook for Austedo

Austedo will be eligible for patent challenges on April 3, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 18, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AUSTEDO

International Patents:	52
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	17
Clinical Trials:	3
Patent Applications:	46
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AUSTEDO
What excipients (inactive ingredients) are in AUSTEDO?	AUSTEDO excipients list
DailyMed Link:	AUSTEDO at DailyMed

See drug prices for AUSTEDO

Generic Entry Opportunity 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

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			Y	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			Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-001	Apr 3, 2017		RX	Yes	No
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-001	Apr 3, 2017		RX	Yes	No			Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-002	Apr 3, 2017		RX	Yes	No			Y	Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-001	Apr 3, 2017		RX	Yes	No

International Patents for AUSTEDO

Country	Patent Number	Estimated Expiration
European Patent Office	2897615
Spain	2563820
Hong Kong	1212232
Spain	2425623
China	111728971
New Zealand	591615
Australia	2018222896