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Last Updated: April 13, 2024

MYRBETRIQ GRANULES Drug Patent Profile


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When do Myrbetriq Granules patents expire, and what generic alternatives are available?

Myrbetriq Granules is a drug marketed by Apgdi and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in twenty-three countries.

The generic ingredient in MYRBETRIQ GRANULES 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 Granules

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

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Paragraph IV (Patent) Challenges for MYRBETRIQ GRANULES
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MYRBETRIQ GRANULES Granules for Extended-release Suspension mirabegron 8 mg/mL 213801 1 2024-01-12

US Patents and Regulatory Information for MYRBETRIQ GRANULES

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

Patents protecting MYRBETRIQ GRANULES

Pharmaceutical composition containing mirabegron
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

FDA Regulatory Exclusivity protecting MYRBETRIQ GRANULES

NEW PRODUCT
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 GRANULES mirabegron FOR SUSPENSION, EXTENDED RELEASE;ORAL 213801-001 Mar 25, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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 ⤷  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
Apgdi MYRBETRIQ GRANULES mirabegron FOR SUSPENSION, EXTENDED RELEASE;ORAL 213801-001 Mar 25, 2021 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

EU/EMA Drug Approvals for MYRBETRIQ GRANULES

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 GRANULES

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

Country Patent Number Title Estimated Expiration
Norway 20042227 ⤷  Try a Trial
Mexico PA04003936 CRISTAL EN FORMA ALFA O EN FORMA BETA DE DERIVADO DE ACETANILIDA. (alpha-FORM OR ß-FORM CRYSTAL OF ACETANILIDE DERIVATIVE.) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9920607 ⤷  Try a Trial
Argentina 017340 UN DERIVADO DE AMIDA, SU USO Y UNA COMPOSICION FARMACEUTICA QUE LO COMPRENDE. ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MYRBETRIQ GRANULES

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1559427 2013C/040 Belgium ⤷  Try a Trial PRODUCT NAME: MIRABEGRON OU L'UN DES SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/12/809/001 20130107
1559427 168 5014-2013 Slovakia ⤷  Try a Trial PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: EU/1/12/809/001 - EU/1/12/809/014 20121220
1559427 33/2013 Austria ⤷  Try a Trial PRODUCT NAME: MIRABEGRON ODER DESSEN SALZE; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1028111 CA 2013 00029 Denmark ⤷  Try a Trial PRODUCT NAME: MIRABEGRON OR SALTS THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.