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Last Updated: September 27, 2020

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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 two branded drugs marketed by Sawai Usa and Apgdi, and is included in two NDAs. There are seven 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 twenty patent family members in twenty-nine 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.

Recent Clinical Trials for mirabegron

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

SponsorPhase
Boryung Pharmaceutical Co., LtdPhase 1
Mansoura UniversityPhase 3
Chang Gung Memorial HospitalN/A

See all mirabegron clinical trials

Generic filers with tentative approvals for MIRABEGRON
Applicant Application No. Strength Dosage Form
  Start Trial  Start 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.

Pharmacology for mirabegron
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   Start Trial   Start Trial Y Y   Start Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012   Start Trial   Start Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012   Start Trial   Start Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012   Start Trial   Start 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 300599 Netherlands   Start Trial PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20130107
1559427 33/2013 Austria   Start Trial PRODUCT NAME: MIRABEGRON ODER DESSEN SALZE; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427 CR 2013 00028 Denmark   Start Trial PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
1028111 C300598 Netherlands   Start Trial PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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