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Last Updated: September 28, 2021

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Details for New Drug Application (NDA): 202611


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NDA 202611 describes MYRBETRIQ, which is a drug marketed by Apgdi and is included in two NDAs. It is available from three suppliers. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MYRBETRIQ profile page.

The generic ingredient in MYRBETRIQ is mirabegron. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mirabegron profile page.
Summary for 202611
Tradename:MYRBETRIQ
Applicant:Apgdi
Ingredient:mirabegron
Patents:7
Suppliers and Packaging for NDA: 202611
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611 NDA Astellas Pharma US, Inc. 0469-2601 0469-2601-30 1 BOTTLE in 1 CARTON (0469-2601-30) > 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611 NDA Astellas Pharma US, Inc. 0469-2601 0469-2601-90 1 BOTTLE in 1 CARTON (0469-2601-90) > 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Paragraph IV (Patent) Challenges for 202611
Tradename Dosage Ingredient NDA Submissiondate
MYRBETRIQ TABLET, EXTENDED RELEASE;ORAL mirabegron 202611 2016-06-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25MG
Approval Date:Jun 28, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 27, 2021
Regulatory Exclusivity Use:CO-ADMINISTRATION THERAPY OF MIRABEGRON WITH SOLIFENACIN SUCCINATE FOR TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
Regulatory Exclusivity Expiration:Sep 25, 2024
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Mar 25, 2024
Regulatory Exclusivity Use:TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 3 YEARS AND OLDER AND WEIGHING 35 KILOGRAMS OR MORE

Expired US Patents for NDA 202611

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 ⤷  Free Forever Trial ⤷  Free Forever Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 ⤷  Free Forever Trial ⤷  Free Forever Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 ⤷  Free Forever Trial ⤷  Free Forever Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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