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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Julphar
US Department of Justice
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Colorcon
Federal Trade Commission
Harvard Business School
Argus Health
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Generated: December 13, 2017

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 and sixteen supplementary protection certificates in eleven countries.

There are sixteen drug master file entries for mirabegron. Three suppliers are listed for this compound.

Pharmacology for mirabegron

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
ApgdiMYRBETRIQmirabegronTABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
ApgdiMYRBETRIQmirabegronTABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
ApgdiMYRBETRIQmirabegronTABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
ApgdiMYRBETRIQmirabegronTABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
ApgdiMYRBETRIQmirabegronTABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
ApgdiMYRBETRIQmirabegronTABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ApgdiMYRBETRIQmirabegronTABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ApgdiMYRBETRIQmirabegronTABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ApgdiMYRBETRIQmirabegronTABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ApgdiMYRBETRIQmirabegronTABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: mirabegron

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
ApgdiMYRBETRIQmirabegronTABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012► Subscribe► Subscribe
ApgdiMYRBETRIQmirabegronTABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012► Subscribe► Subscribe
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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► Subscribe
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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
Hungary227560► Subscribe
Denmark1559427► Subscribe
Hungary229295► Subscribe
Austria500827► Subscribe
China1575287► Subscribe
China1373673► Subscribe
European Patent Office1205190► Subscribe
Norway2013013► Subscribe
Poland376771► Subscribe
Poland353154► Subscribe
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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
2013 00028Denmark► SubscribePRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
90028-7Sweden► SubscribePRODUCT NAME: MIRABEGRON ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/12/809/001 20121220
1559427/01Switzerland► SubscribePRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: SWISSMEDIC 62755 19.05.2014
0599Netherlands► SubscribePRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20130107
0598Netherlands► SubscribePRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
0130015 00094Estonia► SubscribePRODUCT NAME: MIRABEGROON;REG NO/DATE: K(2012)9945 (LOPLIK) 20.12.2012
2013 00028Denmark► Subscribe
13/026Ireland► SubscribePRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
00598Netherlands► SubscribePRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
C/GB13/035United Kingdom► SubscribePRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTERED: UK EU/1/12/809/001-014 20130107
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Serving leading biopharmaceutical companies globally:

Colorcon
US Army
Cantor Fitzgerald
McKesson
Cerilliant
Farmers Insurance
Federal Trade Commission
Accenture
Chubb
Mallinckrodt

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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