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Serving leading biopharmaceutical companies globally:

Dow
Baxter
Mallinckrodt
Federal Trade Commission
Deloitte
QuintilesIMS
Chinese Patent Office
Boehringer Ingelheim
Chubb
Express Scripts

Generated: February 23, 2018

DrugPatentWatch Database Preview

Mirabegron - Generic Drug Details

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

Mirabegron
is the generic ingredient in one branded drug marketed by Apgdi and is included in one NDA. There are six 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 seven patent family members in twenty-eight countries.

There are sixteen drug master file entries for mirabegron. Three suppliers are listed for this compound.
Summary for mirabegron
International Patents:107
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 16
Suppliers / Packagers: 3
Bulk Api Vendors: 37
Clinical Trials: 89
Patent Applications: 76
Drug Prices:see low prices
DailyMed Link:mirabegron at DailyMed
Pharmacology for mirabegron

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
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ 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

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Expired US Patents for mirabegron

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 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

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Non-Orange Book US Patents for mirabegron

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,750,029 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for mirabegron

Supplementary Protection Certificates for mirabegron

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90028-7 Sweden ➤ Sign Up PRODUCT NAME: MIRABEGRON ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/12/809/001 20121220
C/GB13/035 United Kingdom ➤ Sign Up PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTERED: UK EU/1/12/809/001-014 20130107
218 Luxembourg ➤ Sign Up PRODUCT NAME: MIRABEGRON OU UN DE SES SELS
8 5014-2013 Slovakia ➤ Sign Up PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: EU/1/12/809/001 - EU/1/12/809/014 20121220
00599 Netherlands ➤ Sign Up PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
0599 Netherlands ➤ Sign Up PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20130107
00598 Netherlands ➤ Sign Up PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427/01 Switzerland ➤ Sign Up PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: SWISSMEDIC 62755 19.05.2014
0598 Netherlands ➤ Sign Up PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
7 Finland ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fuji
Healthtrust
Farmers Insurance
McKinsey
Daiichi Sankyo
Accenture
UBS
Teva

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 verifification 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.

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