DEUTETRABENAZINE - Generic Drug Details

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What are the generic drug sources for deutetrabenazine and what is the scope of patent protection?

Deutetrabenazine is the generic ingredient in two branded drugs marketed by Teva and Teva Branded Pharm, and is included in two NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Deutetrabenazine has one hundred and forty-eight patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for DEUTETRABENAZINE

International Patents:	148
US Patents:	14
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	15
Patent Applications:	3,861
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEUTETRABENAZINE
What excipients (inactive ingredients) are in DEUTETRABENAZINE?	DEUTETRABENAZINE excipients list
DailyMed Link:	DEUTETRABENAZINE at DailyMed

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

Generic Entry Dates for DEUTETRABENAZINE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL
Generic Entry Dates for DEUTETRABENAZINE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 DEUTETRABENAZINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Vanderbilt University Medical Center	Phase 2/Phase 3
Fundacion Huntington Puerto Rico	Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.	Phase 1/Phase 2

See all DEUTETRABENAZINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DEUTETRABENAZINE

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

Paragraph IV (Patent) Challenges for DEUTETRABENAZINE

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 DEUTETRABENAZINE

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

International Patents for DEUTETRABENAZINE

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Country	Patent Number	Title	Estimated Expiration
Canada	3056612	ANALOGUES DE DEUTETRABENAZINE, LEUR PREPARATION ET LEUR UTILISATION (ANALOGS OF DEUTETRABENAZINE, THEIR PREPARATION AND USE)	⤷ Sign Up
New Zealand	591615	BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2	⤷ Sign Up
Hungary	E038158		⤷ Sign Up
Australia	2016229949	Methods for the treatment of abnormal involuntary movement disorders	⤷ Sign Up
South Korea	20170122820	비정상적 불수의 운동 장애의 치료 방법	⤷ Sign Up
Japan	2024050724	デューテトラベナジンの類似体、その調製及び使用	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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