Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Additional Information about Patents

• Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
• Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
• As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N216354

Product 001
DEUTETRABENAZINE (AUSTEDO XR) TABLET, EXTENDED RELEASE 6MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8524733	04/03/2031	DS	DP			02/27/2023
001	8524733*PED	10/03/2031
001	9550780	09/18/2033	DS	DP	U-1995 U-3055		02/27/2023
001	9550780*PED	03/18/2034
001	10959996	03/07/2036			U-3055		02/27/2023
001	10959996*PED	09/07/2036
001	11179386	03/15/2038		DP	U-1995 U-3055		02/27/2023
001	11179386*PED	09/15/2038
001	11311488	06/10/2041		DP	U-1995 U-3055		02/27/2023
001	11357772	03/07/2036			U-1995 U-3055		02/27/2023
001	11357772*PED	09/07/2036
001	11446291	03/07/2036			U-1995		02/27/2023
001	11446291*PED	09/07/2036
001	11564917	03/07/2036			U-1995		02/27/2023
001	11564917*PED	09/07/2036
001	11648244	03/07/2036			U-1995		06/05/2023
001	11648244*PED	09/07/2036
001	11813232	03/15/2038		DP			12/07/2023
001	11813232*PED	09/15/2038

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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