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Serving leading biopharmaceutical companies globally:

Queensland Health
Julphar
Cantor Fitzgerald
Argus Health
Cerilliant
Farmers Insurance
Johnson and Johnson
Boehringer Ingelheim
Accenture
AstraZeneca

Generated: January 21, 2018

DrugPatentWatch Database Preview

MYRBETRIQ Drug Profile

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Which patents cover Myrbetriq, and what generic alternatives are available?

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

This drug has one hundred and seven patent family members in twenty-eight countries.

The generic ingredient in MYRBETRIQ is mirabegron. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mirabegron profile page.
Summary for MYRBETRIQ
International Patents:107
US Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: 3
Bulk Api Vendors: 37
Clinical Trials: 33
Patent Applications: 41
Drug Prices:see details
DailyMed Link:MYRBETRIQ at DailyMed
Drug patent expirations by year for MYRBETRIQ
Pharmacology for MYRBETRIQ

US Patents and Regulatory Information for MYRBETRIQ

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 ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 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 ➤ Subscribe ➤ Subscribe
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for MYRBETRIQ
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 25 mg and 50 mg ➤ Subscribe 6/28/2016

Non-Orange Book US Patents for MYRBETRIQ

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 ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for MYRBETRIQ

Supplementary Protection Certificates for MYRBETRIQ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1559427/01 Switzerland ➤ Subscribe PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: SWISSMEDIC 62755 19.05.2014
13/026 Ireland ➤ Subscribe PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
00599 Netherlands ➤ Subscribe PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
7 Finland ➤ Subscribe
2013 00028 Denmark ➤ Subscribe PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
C0032 France ➤ Subscribe PRODUCT NAME: MIRABEGRON ET SES SELS; REGISTRATION NO/DATE: EU/1/12/809/001 20121220
00598 Netherlands ➤ Subscribe PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
2013 00028 Denmark ➤ Subscribe
C/GB13/035 United Kingdom ➤ Subscribe PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTERED: UK EU/1/12/809/001-014 20130107
0130015 00094 Estonia ➤ Subscribe PRODUCT NAME: MIRABEGROON;REG NO/DATE: K(2012)9945 (LOPLIK) 20.12.2012
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Queensland Health
Medtronic
Fish and Richardson
Novartis
AstraZeneca
Teva
Boehringer Ingelheim

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