Details for New Drug Application (NDA): 208082
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NDA 208082 describes AUSTEDO, which is a drug marketed by Teva Branded Pharm and Teva and is included in two NDAs. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the AUSTEDO profile page.
The generic ingredient in AUSTEDO is deutetrabenazine. One supplier is listed for this compound. Additional details are available on the deutetrabenazine profile page.
The generic ingredient in AUSTEDO is deutetrabenazine. One supplier is listed for this compound. Additional details are available on the deutetrabenazine profile page.
Summary for 208082
| Tradename: | AUSTEDO |
| Applicant: | Teva Branded Pharm |
| Ingredient: | deutetrabenazine |
| Patents: | 13 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208082
Generic Entry Date for 208082*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 208082
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082 | NDA | Teva Neuroscience, Inc. | 68546-170 | 68546-170-60 | 60 TABLET, COATED in 1 BOTTLE (68546-170-60) |
| AUSTEDO | deutetrabenazine | TABLET;ORAL | 208082 | NDA | Teva Neuroscience, Inc. | 68546-171 | 68546-171-60 | 60 TABLET, COATED in 1 BOTTLE (68546-171-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
| Approval Date: | Apr 3, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 24, 2024 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL | ||||||||
| Regulatory Exclusivity Expiration: | Dec 24, 2024 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 3, 2024 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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