Details for New Drug Application (NDA): 216354
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The generic ingredient in AUSTEDO XR is deutetrabenazine. 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: | 11 |
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: | ⤷ Sign Up | Patent Expiration: | Sep 7, 2036 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 15, 2038 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | 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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