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Last Updated: March 3, 2024

MYRBETRIQ Drug Patent Profile


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Which patents cover Myrbetriq, and when can generic versions of Myrbetriq launch?

Myrbetriq is a drug marketed by Apgdi and is included in two NDAs. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eleven patent family members in thirty countries.

The generic ingredient in MYRBETRIQ is mirabegron. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mirabegron profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Myrbetriq

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

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Drug patent expirations by year for MYRBETRIQ
Drug Prices for MYRBETRIQ

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Drug Sales Revenue Trends for MYRBETRIQ

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Recent Clinical Trials for MYRBETRIQ

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

SponsorPhase
The University of Texas Medical Branch, GalvestonEarly Phase 1
University of California, San DiegoPhase 1
Shachi TyagiPhase 4

See all MYRBETRIQ clinical trials

Paragraph IV (Patent) Challenges for MYRBETRIQ
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MYRBETRIQ Extended-release Tablets mirabegron 50 mg 202611 6 2016-06-28

US Patents and Regulatory Information for MYRBETRIQ

MYRBETRIQ is protected by seven US patents and two FDA Regulatory Exclusivities.

Patents protecting MYRBETRIQ

Pharmaceutical composition for modified release
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

.alpha.-form or .beta.-form crystal of acetanilide derivative
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

.alpha.-form or .beta.-form crystal of acetanilide derivative
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical composition for treating overactive bladder
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting MYRBETRIQ

TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 3 YEARS AND OLDER AND WEIGHING 35 KILOGRAMS OR MORE
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  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
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 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 202611-001 Jun 28, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 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 Y ⤷  Try a Trial
Apgdi MYRBETRIQ GRANULES mirabegron FOR SUSPENSION, EXTENDED RELEASE;ORAL 213801-001 Mar 25, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 MYRBETRIQ

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 202611-002 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 202611-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for MYRBETRIQ

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 MYRBETRIQ

When does loss-of-exclusivity occur for MYRBETRIQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Patent: 04298
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0121078
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 13670
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 16021
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 16021
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 2009057685
Estimated Expiration: ⤷  Try a Trial

Patent: 63170
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 16021
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 16021
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 16021
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 93525
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MYRBETRIQ around the world.

Country Patent Number Title Estimated Expiration
Cyprus 1113670 ⤷  Try a Trial
Hungary 0202495 ⤷  Try a Trial
China 1091004 ⤷  Try a Trial
Slovakia 33895 SUBSTAINED-RELEASE HYDROGEL PREPARATION ⤷  Try a Trial
Russian Federation 2303033 АЛЬФА-ФОРМА ИЛИ БЕТА-ФОРМА КРИСТАЛЛА ПРОИЗВОДНОГОАЦЕТАНИЛИДА (ALPHA-FORM OR BETA-FORM OF CRYSTAL OF ACETANILIDE DERIVATIVE) ⤷  Try a Trial
Canada 2503570 REMEDE POUR VESSIE HYPERACTIVE COMPRENANT UN DERIVE ANILIDE DE L'ACIDE ACETIQUE EN TANT QU'INGREDIENT ACTIF (REMEDY FOR OVERACTIVE BLADDER COMPRISING ACETIC ACID ANILIDEDERIVATIVE AS THE ACTIVE INGREDIENT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MYRBETRIQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1559427 C20130015 00094 Estonia ⤷  Try a Trial PRODUCT NAME: MIRABEGROON;REG NO/DATE: K(2012)9945 (LOPLIK) 20.12.2012
1559427 C01559427/01 Switzerland ⤷  Try a Trial PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: SWISSMEDIC 62755 19.05.2014
1559427 CA 2013 00028 Denmark ⤷  Try a Trial
1028111 300598 Netherlands ⤷  Try a Trial PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1028111 C300598 Netherlands ⤷  Try a Trial PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427 300599 Netherlands ⤷  Try a Trial PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20130107
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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