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Last Updated: November 21, 2024

MIRABEGRON Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Mirabegron

A generic version of MIRABEGRON was approved as mirabegron by LUPIN LTD on September 28th, 2022.

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Drug patent expirations by year for MIRABEGRON
Recent Clinical Trials for MIRABEGRON

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SponsorPhase
Seoul National University HospitalPhase 2
Il-Yang Pharm. Co., Ltd.Phase 2
Cedars-Sinai Medical CenterPhase 2

See all MIRABEGRON clinical trials

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
Alkem Labs Ltd MIRABEGRON mirabegron TABLET, EXTENDED RELEASE;ORAL 215948-001 Feb 12, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms MIRABEGRON mirabegron TABLET, EXTENDED RELEASE;ORAL 209488-002 Sep 29, 2022 AB RX 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 215948-002 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
Zydus Pharms MIRABEGRON mirabegron TABLET, EXTENDED RELEASE;ORAL 209488-001 Sep 29, 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

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

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