Details for New Drug Application (NDA): 216354
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NDA 216354 describes AUSTEDO XR, which is a drug marketed by Teva and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the AUSTEDO XR profile page.
The generic ingredient in AUSTEDO XR 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 XR 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 216354
| Tradename: | AUSTEDO XR |
| Applicant: | Teva |
| Ingredient: | deutetrabenazine |
| Patents: | 13 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216354
Generic Entry Date for 216354*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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: 216354
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AUSTEDO XR | deutetrabenazine | TABLET, EXTENDED RELEASE;ORAL | 216354 | NDA | Teva Neuroscience, Inc. | 68546-470 | 68546-470-56 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-470-56) |
| AUSTEDO XR | deutetrabenazine | TABLET, EXTENDED RELEASE;ORAL | 216354 | NDA | Teva Neuroscience, Inc. | 68546-471 | 68546-471-56 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-471-56) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6MG | ||||
| Approval Date: | Feb 17, 2023 | 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: | 11,311,488 | Patent Expiration: | Jun 10, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD OF TREATING HUNTINGTON'S CHOREA | ||||||||
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