You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

MYRBETRIQ Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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. Six 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.

  Try a Trial

Drug patent expirations by year for MYRBETRIQ
Drug Prices for MYRBETRIQ

See drug prices for MYRBETRIQ

Drug Sales Revenue Trends for MYRBETRIQ

See drug sales revenues for MYRBETRIQ

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 ⤷  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 ⤷  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 MYRBETRIQ

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
>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
European Patent Office 1205190 COMPOSITIONS MEDICINALES STABLES POUR ADMINISTRATION ORALE EN UTILISANT DES OXYDES DE FER (STABLE MEDICINAL COMPOSITIONS FOR ORAL USE USING FERRIC OXIDES) ⤷  Try a Trial
Poland 2345410 ⤷  Try a Trial
Spain 2360353 ⤷  Try a Trial
Taiwan 557295 ⤷  Try a Trial
Slovenia 1559427 ⤷  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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.