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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Medtronic
Healthtrust
Federal Trade Commission
QuintilesIMS
McKinsey
UBS
Cantor Fitzgerald
AstraZeneca

Generated: November 19, 2017

DrugPatentWatch Database Preview

MYRBETRIQ Drug Profile

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Which patents cover Myrbetriq, and what generic Myrbetriq 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 and sixteen supplementary protection certificates in eleven 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

Pharmacology 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;ORAL202611-001Jun 28, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: MYRBETRIQ

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 2012► Subscribe► Subscribe
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 2012► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for MYRBETRIQ

Drugname Dosage Strength RLD Submissiondate
mirabegronExtended-release Tablets25 mg and 50 mgMyrbetriq6/28/2016

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► 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 Tradename: MYRBETRIQ

Country Document Number Estimated Expiration
Hungary0202495► Subscribe
Taiwan200300020► Subscribe
World Intellectual Property Organization (WIPO)2004041276► Subscribe
Brazil0316080► Subscribe
Brazil0213570► Subscribe
Germany69823858► Subscribe
South Korea100908796► Subscribe
Australia8928898► Subscribe
Norway326965► Subscribe
Norway2015001► 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: MYRBETRIQ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1559427/01Switzerland► SubscribePRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: SWISSMEDIC 62755 19.05.2014
C0032France► SubscribePRODUCT NAME: MIRABEGRON ET SES SELS; REGISTRATION NO/DATE: EU/1/12/809/001 20121220
C/GB13/035United Kingdom► SubscribePRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTERED: UK EU/1/12/809/001-014 20130107
2013 00028Denmark► Subscribe
0130015 00094Estonia► SubscribePRODUCT NAME: MIRABEGROON;REG NO/DATE: K(2012)9945 (LOPLIK) 20.12.2012
00598Netherlands► SubscribePRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
13/026Ireland► SubscribePRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
2013 00028Denmark► SubscribePRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
8 5014-2013Slovakia► SubscribePRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: EU/1/12/809/001 - EU/1/12/809/014 20121220
0599Netherlands► SubscribePRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20130107
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
QuintilesIMS
Healthtrust
Johnson and Johnson
AstraZeneca
Teva
Cipla
Novartis
Federal Trade Commission
Fuji

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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