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Mirabegron - Generic Drug Details

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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. Additional information is available in the individual branded drug profile pages.

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

There are fourteen drug master file entries for mirabegron. Two suppliers are listed for this compound.

Summary for Generic Name: mirabegron

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: see list14
Suppliers / Packaging: see list2

Pharmacology for Ingredient: mirabegron

Clinical Trials for: mirabegron

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, 2012RXNo6,346,532<disabled>YY <disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYes7,342,117<disabled>Y <disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYes6,562,375<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: mirabegron

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 20126,699,503<disabled>
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 20126,699,503<disabled>
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Non-Orange Book Patents for Generic Ingredient: 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
7,750,029Remedy 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 Ingredient: mirabegron

Country Document Number Estimated Expiration
Russian Federation2004116313<disabled in preview>
Japan3815496<disabled in preview>
Norway334948<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: MIRABEGRON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0130015 00094Estonia<disabled>PRODUCT NAME: MIRABEGROON;REG NO/DATE: K(2012)9945 (LOPLIK) 20.12.2012
2013 00029Denmark<disabled>PRODUCT NAME: MIRABEGRON OR SALTS THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
00599Netherlands<disabled>PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
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