Deutetrabenazine - Generic Drug Details
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What are the generic sources for deutetrabenazine and what is the scope of freedom to operate?
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 thirty-six patent family members in thirty-three countries.
One supplier is listed for this compound.
Summary for deutetrabenazine
International Patents: | 136 |
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*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
Generic Entry Dates for deutetrabenazine*:
Constraining patent/regulatory exclusivity:
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 |
Anatomical Therapeutic Chemical (ATC) Classes for deutetrabenazine
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
International Patents for deutetrabenazine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2023240186 | ⤷ Try a Trial | |
South Korea | 20210149246 | 비정상적 불수의 운동 장애의 치료 방법 (METHODS FOR THE TREATMENT OF ABNORMAL INVOLUNTARY MOVEMENT DISORDERS) | ⤷ Try a Trial |
India | 1662DEN2015 | ⤷ Try a Trial | |
Japan | 2023010754 | デューテトラベナジンの類似体、その調製及び使用 | ⤷ Try a Trial |
Poland | 3265085 | ⤷ Try a Trial | |
Peru | 20230852 | FORMAS FARMACEUTICAS OSMOTICAS QUE COMPRENDEN DEUTETRABENAZINA Y METODOS DE USO DE LAS MISMAS | ⤷ Try a Trial |
Australia | 2009303758 | Benzoquinoline inhibitors of vesicular monoamine transporter 2 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |