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Last Updated: November 21, 2024

MIRABEGRON - Generic Drug Details


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

Mirabegron is the generic ingredient in three branded drugs marketed by Apgdi, Alkem Labs Ltd, Lupin Ltd, Sawai Usa, and Zydus Pharms, and is included in six NDAs. There are ten 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
Seoul National University HospitalPhase 2
Il-Yang Pharm. Co., Ltd.Phase 2
Cedars-Sinai Medical CenterPhase 2

See all MIRABEGRON clinical trials

Generic filers with tentative approvals for MIRABEGRON
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up50MGTABLET, 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
Sawai Usa MIRABEGRON mirabegron TABLET, EXTENDED RELEASE;ORAL 209446-001 Dec 27, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin Ltd MIRABEGRON mirabegron TABLET, EXTENDED RELEASE;ORAL 209485-002 Sep 28, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd MIRABEGRON mirabegron TABLET, EXTENDED RELEASE;ORAL 215948-001 Feb 12, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin Ltd MIRABEGRON mirabegron TABLET, EXTENDED RELEASE;ORAL 209485-001 Sep 28, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 202611-002 Jun 28, 2012 ⤷  Sign Up ⤷  Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 ⤷  Sign Up ⤷  Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 ⤷  Sign Up ⤷  Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 ⤷  Sign Up ⤷  Sign Up
>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
Poland 369874 ⤷  Sign Up
Portugal 2216021 ⤷  Sign Up
China 1711085 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient ⤷  Sign Up
Japan WO2004041276 酢酸アニリド誘導体を有効成分とする過活動膀胱治療剤 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MIRABEGRON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1028111 C300598 Netherlands ⤷  Sign Up PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427 2013/026 Ireland ⤷  Sign Up PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427 C20130015 00094 Estonia ⤷  Sign Up PRODUCT NAME: MIRABEGROON;REG NO/DATE: K(2012)9945 (LOPLIK) 20.12.2012
1559427 168 5014-2013 Slovakia ⤷  Sign Up PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: EU/1/12/809/001 - EU/1/12/809/014 20121220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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