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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Deloitte
UBS
Moodys
Boehringer Ingelheim
QuintilesIMS
Healthtrust
Queensland Health
Federal Trade Commission

Generated: June 20, 2018

DrugPatentWatch Database Preview

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 two 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 seventeen drug master file entries for this compound. Two 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 N 0469-2601-30
MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611 NDA Astellas Pharma US, Inc. 0469-2601 N 0469-2601-71

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:➤ Try a Free TrialPatent Expiration:Mar 27, 2022Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Aug 1, 2020Product Flag?YSubstance Flag?Delist Request?

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

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Fuji
Dow
Fish and Richardson
Cantor Fitzgerald
Teva
Mallinckrodt
Farmers Insurance
Julphar

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