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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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Deutetrabenazine has fifty-two patent family members in twenty countries.
One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for deutetrabenazine
| International Patents: | 52 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 17 |
| Clinical Trials: | 14 |
| Patent Applications: | 48 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | deutetrabenazine at DailyMed |
Recent Clinical Trials for deutetrabenazine
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 |
Generic filers with tentative approvals for DEUTETRABENAZINE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 12MG | TABLET;ORAL |
| Start Trial | Start Trial | 9MG | TABLET;ORAL |
| Start Trial | Start Trial | 6MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 | Start Trial | Start Trial | Start Trial | ||||
| Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-002 | Apr 3, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-003 | Apr 3, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-003 | Apr 3, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-001 | Apr 3, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-002 | Apr 3, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >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 | Estimated Expiration |
|---|---|---|
| Portugal | 3061760 | Start Trial |
| Australia | 2020205297 | Start Trial |
| Japan | 6612420 | Start Trial |
| Denmark | 2326643 | Start Trial |
| Norway | 3061760 | Start Trial |
| Spain | 2563820 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
