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Last Updated: October 26, 2021

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Mirabegron - Generic Drug Details

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What are the generic drug sources for mirabegron and what is the scope of patent protection?

Mirabegron is the generic ingredient in three branded drugs marketed by Apgdi and Sawai Usa, and is included in three NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Mirabegron has one hundred and thirty-nine patent family members in thirty-two countries.

There are nineteen drug master file entries for mirabegron. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for mirabegron
Recent Clinical Trials for mirabegron

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Alabama at BirminghamPhase 4
China Medical University HospitalPhase 4
Indiana UniversityPhase 1/Phase 2

See all mirabegron clinical trials

Generic filers with tentative approvals for MIRABEGRON
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial50MGTABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for MIRABEGRON
Tradename Dosage Ingredient NDA Submissiondate
MYRBETRIQ TABLET, EXTENDED RELEASE;ORAL mirabegron 202611 2016-06-28

US Patents and Regulatory Information for mirabegron

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for mirabegron

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 202611-002 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

Supplementary Protection Certificates for mirabegron

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1559427 C 2013 020 Romania ⤷  Free Forever Trial PRODUCT NAME: MIRABEGRON SAU O SARE A ACESTUIA(2-(2-AMINO-1,3-TRIAZOL-4-IL)-N-[4-(2-{[(2R)-2-HIDROXI-2-FENILETIL]AMINO}ETIL)FENIL]ACETAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/12/809/001 - EU/1/12/809/014; DATE OF NATIONAL AUTHORISATION: 20121220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/809/001 - EU/1/12/809/014; DATE OF FIRST AUTHORISATION IN EEA: 20121220
1559427 C01559427/01 Switzerland ⤷  Free Forever Trial PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: SWISSMEDIC 62755 19.05.2014
1559427 300599 Netherlands ⤷  Free Forever Trial PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20130107
1559427 122013000047 Germany ⤷  Free Forever Trial PRODUCT NAME: MIRABEGRON ODER EIN SALZ DAVON; NAT. REGISTRATION NO/DATE: EU /1/12/809/001-014 20121220; FIRST REGISTRATION: EU EU/1/12/809/001-014 20121220
1559427 CA 2013 00028 Denmark ⤷  Free Forever Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Merck
Harvard Business School
Dow
McKinsey

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