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AUSTEDO Drug Profile
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Which patents cover Austedo, and what generic alternatives are available?
Austedo is a drug marketed by Teva Branded Pharm and is included in one NDA. There are five patents protecting this drug.
This drug has forty-seven patent family members in twenty countries.
The generic ingredient in AUSTEDO is deutetrabenazine. One supplier is listed for this compound. Additional details are available on the deutetrabenazine profile page.
US ANDA Litigation and Generic Entry Outlook for Austedo
Austedo will be eligible for patent challenges on April 3, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 18, 2033. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for AUSTEDO
| International Patents: | 47 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 14 |
| Clinical Trials: | 1 |
| Patent Applications: | 7 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AUSTEDO |
| DailyMed Link: | AUSTEDO at DailyMed |
Generic Entry Opportunity Date for AUSTEDO
Generic Entry Date for AUSTEDO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 AUSTEDO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Pennsylvania | Phase 1/Phase 2 |
| Teva Branded Pharmaceutical Products, R&D Inc. | Phase 1/Phase 2 |
Synonyms for AUSTEDO
| (+)-Tetrabenazine D6 |
| (3R,11bR)-3-(2-methylpropyl)-9,10-bis(trideuteriomethoxy)-1,3,4,6,7,11b-hexahydrobenzo[a]quinolizin-2-one |
| (3RS,11Brs)-9,10-di((2H3)methoxy)-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2H-benzo(a)quinolizin-2-one |
| [2H6]-(+)-Tetrabenazine|||[2H6]-(+)- 9,10-Dimethoxy-1,3R,4,6,7,11bR-hexahydro-3-isobutyl-2H-benzo[a]quinolizin-2-one |
| 1392826-25-3 |
| 1977511-05-9 |
| 2H-Benzo(a)quinolizin-2-one, 1,3,4,6,7,11b-hexahydro-9,10-di(methoxy-d3)-3-(2-methylpropyl)-, (3R,11bR)-rel- |
| D10701 |
| DB12161 |
| Deutetrabenazine |
| Deutetrabenazine (USAN/INN) |
| Deutetrabenazine [USAN:INN] |
| Dutetrabenazine |
| GTPL8707 |
| HY-B0590S |
| Ro 1-9569 D6 |
| SCHEMBL16227993 |
| SCHEMBL16228022 |
| SD 809 |
| SD-809 |
| SD809 |
| Tetrabenazine D6 |
| Tetrabenazine-d6 |
| UNII-P341G6W9NB component MKJIEFSOBYUXJB-VFJJUKLQSA-N |
| UNII-P341G6W9NB component MKJIEFSOBYUXJB-WEZHFFAMSA-N |
US Patents and Regulatory Information for AUSTEDO
| 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 | 208082-001 | Apr 3, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| 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 | 208082-003 | 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 | 208082-001 | Apr 3, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Branded Pharm | AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082-002 | Apr 3, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | 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 AUSTEDO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2013318182 | Start Trial |
| Japan | 6138322 | Start Trial |
| Portugal | 3061760 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2010044981 | Start Trial |
| China | 102186848 | Start Trial |
| Hong Kong | 1222853 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
