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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Deutetrabenazine has one hundred and nine patent family members in thirty-two countries.
One supplier is listed for this compound.
Summary for deutetrabenazine
| International Patents: | 109 |
| US Patents: | 9 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 24 |
| Clinical Trials: | 15 |
| Patent Applications: | 3,717 |
| 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 |
| University of Pennsylvania | Phase 1/Phase 2 |
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 | 208082-002 | 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 | Y | See Plans and Pricing | |||
| Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-001 | 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 |
|---|---|---|---|
| Slovenia | 3061760 | See Plans and Pricing | |
| South Korea | 102335744 | See Plans and Pricing | |
| Israel | 269132 | אנאלוגים של דאוטטרבנזין, הכנתם ושימוש בהם (Analogs of deutetrabenazine, their preparation and use) | See Plans and Pricing |
| Portugal | 3265085 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
