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Last Updated: July 7, 2020

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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 one NDA. It is available from three suppliers. There are seven 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
Pharmacology for NDA: 202611
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 0469-2601-71 10 BLISTER PACK in 1 CARTON (0469-2601-71) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
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
Patent:  Start TrialPatent Expiration:Mar 27, 2022Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Aug 1, 2020Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

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