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Last Updated: September 21, 2021

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Mirabegron - Generic Drug Details

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What are the generic sources for mirabegron and what is the scope of freedom to operate?

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
Office of Naval Research (ONR)Phase 1/Phase 2

See all mirabegron clinical trials

Generic filers with tentative approvals for MIRABEGRON
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free50MGTABLET, 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 202611-001 Jun 28, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Apgdi MYRBETRIQ GRANULES mirabegron FOR SUSPENSION, EXTENDED RELEASE;ORAL 213801-001 Mar 25, 2021 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 ⤷  Try it Free ⤷  Try it Free
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 ⤷  Try it Free ⤷  Try it Free
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 ⤷  Try it Free ⤷  Try it Free
>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 SPC/GB13/035 United Kingdom ⤷  Try it Free PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTERED: UK EU/1/12/809/001-014 20130107
1559427 13C0032 France ⤷  Try it Free PRODUCT NAME: MIRABEGRON ET SES SELS; REGISTRATION NO/DATE: EU/1/12/809/001 20130107
1559427 457 Finland ⤷  Try it Free
1028111 CA 2013 00029 Denmark ⤷  Try it Free PRODUCT NAME: MIRABEGRON OR SALTS THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Moodys
Johnson and Johnson
McKesson
Mallinckrodt
Medtronic

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