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Last Updated: March 28, 2024

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, Lupin Ltd, Sawai Usa, and Zydus Pharms, and is included in five 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 twenty-four patent family members in thirty-one countries.

There are nineteen drug master file entries for mirabegron. Six 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
The University of Texas Medical Branch, GalvestonEarly Phase 1
University of California, San DiegoPhase 1
Benha UniversityN/A

See all mirabegron clinical trials

Generic filers with tentative approvals for MIRABEGRON
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
MYRBETRIQ GRANULES Granules for Extended-release Suspension mirabegron 8 mg/mL 213801 1 2024-01-12
MYRBETRIQ Extended-release Tablets mirabegron 50 mg 202611 6 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 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd MIRABEGRON mirabegron TABLET, EXTENDED RELEASE;ORAL 209485-001 Sep 28, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 ⤷  Try a Trial ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 ⤷  Try a Trial ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 ⤷  Try a Trial ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 ⤷  Try a Trial ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for mirabegron

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Astellas Pharma Europe B.V. Betmiga mirabegron EMEA/H/C/002388
Symptomatic treatment of urgency.Increased micturition frequency and / or urgency incontinence as may occur in adult patients with overactive-bladder syndrome.
Authorised no no no 2012-12-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for mirabegron

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 03037881 ⤷  Try a Trial
European Patent Office 3827826 COMPOSITION PHARMACEUTIQUE À LIBÉRATION MODIFIÉE (PHARMACEUTICAL COMPOSITION FOR MODIFIED RELEASE) ⤷  Try a Trial
Japan 3800220 ⤷  Try a Trial
Russian Federation 2321401 ЛЕКАРСТВЕННОЕ СРЕДСТВО ПРОТИВ ГИПЕРАКТИВНОГО МОЧЕВОГО ПУЗЫРЯ, ВКЛЮЧАЮЩЕЕ ПРОИЗВОДНОЕ АНИЛИДА УКСУСНОЙ КИСЛОТЫ В КАЧЕСТВЕ АКТИВНОГО ИНГРЕДИЕНТА (DRUG AGAINST HYPERACTIVE BLADDER COMPRISING DERIVATIVE OF ACETIC ACID ANILIDE AS ACTIVE COMPONENT) ⤷  Try a Trial
Denmark 2345410 ⤷  Try a Trial
Taiwan I322805 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for mirabegron

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1559427 C 2013 020 Romania ⤷  Try a Trial PRODUCT NAME: MIRABEGRON SAU O SARE A ACESTUIA(2-(2-AMINO-1,3-TRIAZOL-4-IL)-N-[4-(2-{[(2R)-2-HIDROXI9/014; 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 -2-FENILETIL]AMINO}ETIL)FENIL]ACETAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/12/809/001 - EU/1/12/80
1559427 C20130015 00094 Estonia ⤷  Try a Trial PRODUCT NAME: MIRABEGROON;REG NO/DATE: K(2012)9945 (LOPLIK) 20.12.2012
1559427 132013902166933 Italy ⤷  Try a Trial PRODUCT NAME: MIRABEGRON(BETMIGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/809/014, 20121220
1559427 92218 Luxembourg ⤷  Try a Trial PRODUCT NAME: MIRABEGRON OU UN DE SES SELS
1559427 CA 2013 00028 Denmark ⤷  Try a Trial
1559427 1390028-7 Sweden ⤷  Try a Trial PRODUCT NAME: MIRABEGRON ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/12/809/001 20121220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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