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 seventeen patents protecting this drug. Additional details are available on the AUSTEDO profile page.
The generic ingredient in AUSTEDO is deutetrabenazine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the deutetrabenazine profile page.
The generic ingredient in AUSTEDO is deutetrabenazine. There is one drug master file entry for this compound. 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: | 14 |
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 | |||||
| Patent: | 10,959,996*PED | Patent Expiration: | Sep 7, 2036 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 11,179,386*PED | Patent Expiration: | Sep 15, 2038 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 11,357,772*PED | Patent Expiration: | Sep 7, 2036 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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