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 001
MIRABEGRON (MYRBETRIQ) TABLET, EXTENDED RELEASE 25MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6346532 03/27/2022 DS DP
07/30/2012
001 6346532*PED 09/27/2022
001 7342117 11/04/2023 DS
07/30/2012
001 7342117*PED 05/04/2024
001 7982049 11/04/2023 DP
07/30/2012
001 7982049*PED 05/04/2024
001 8772315 10/30/2028
U-2300 USE IN COMBINATION WITH THE MUSCARINIC ANTAGONIST SOLIFENACIN SUCCINATE FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
05/17/2018
001 8772315*PED 04/30/2029
001 8835474 11/04/2023
U-1527 FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
10/14/2014
001 8835474*PED 05/04/2024
001 10842780 09/28/2029 DP
U-2996 ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
12/11/2020
001 10842780*PED 03/28/2030
001 RE44872 11/04/2023
U-1527 FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
07/16/2014
001 RE44872*PED 05/04/2024

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
I-855TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 3 YEARS AND OLDER AND WEIGHING 35 KILOGRAMS OR MORE
COMPETITIVE GENERIC THERAPY
03/25/2024
001
I-855TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 3 YEARS AND OLDER AND WEIGHING 35 KILOGRAMS OR MORE
*PED PEDIATRIC EXCLUSIVITY
09/25/2024

 

 


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