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 one branded drug marketed by Teva Branded Pharm and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Deutetrabenazine has ninety-five patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for deutetrabenazine
International Patents: | 95 |
US Patents: | 7 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 20 |
Clinical Trials: | 15 |
Patent Applications: | 192 |
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 |
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
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 | 208082-003 | Apr 3, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-002 | Apr 3, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-002 | Apr 3, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-003 | Apr 3, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5616345 | See Plans and Pricing | |
Eurasian Patent Organization | 201992168 | АНАЛОГИ ДЕУТЕТРАБЕНАЗИНА, ИХ ПОЛУЧЕНИЕ И ПРИМЕНЕНИЕ | See Plans and Pricing |
Singapore | 11201706959T | METHODS FOR THE TREATMENT OF ABNORMAL INVOLUNTARY MOVEMENT DISORDERS | See Plans and Pricing |
Australia | 2018222896 | Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |