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MYRBETRIQ Drug Profile

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Myrbetriq is a drug marketed by Apgdi and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug.

This drug has ninety-five patent family members in twenty-seven countries.

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

Summary for Tradename: MYRBETRIQ

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: MYRBETRIQ

Clinical Trials for: MYRBETRIQ

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXNoRE44872Nov 4, 2023
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXNoJun 28, 2017
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXNo7,982,049Nov 4, 2023Y
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Expired Patents for Tradename: MYRBETRIQ

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 20126,699,503<disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 20126,699,503<disabled>
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Non-Orange Book Patents for Tradename: 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
7,750,029Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: MYRBETRIQ

Country Document Number Estimated Expiration
Norway20001983<disabled in preview>
China1218045<disabled in preview>
TaiwanI322805<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: MYRBETRIQ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00029Denmark<disabled>PRODUCT NAME: MIRABEGRON OR SALTS THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
8 5014-2013Slovakia<disabled>PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: EU/1/12/809/001 - EU/1/12/809/014 20121220
13/026Ireland<disabled>PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
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