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: N202611

Product 002
MIRABEGRON (MYRBETRIQ) TABLET, EXTENDED RELEASE 50MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	7342117*PED	05/04/2024
002	7982049*PED	05/04/2024
002	8772315	10/30/2028			U-2300		05/17/2018
002	8772315*PED	04/30/2029
002	8835474*PED	05/04/2024
002	10842780	09/28/2029		DP	U-2996 U-3670		12/11/2020
002	10842780*PED	03/28/2030
002	11707451	09/28/2029			U-2996 U-3670		08/21/2023
002	11707451*PED	03/28/2030
002	RE44872*PED	05/04/2024

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
002	I-855	03/25/2024
002	I-855 *PED	09/25/2024

 

 

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