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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Healthtrust
Express Scripts
Moodys
US Army
UBS
Farmers Insurance
Daiichi Sankyo
Queensland Health

Generated: August 18, 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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighteen patent family members in twenty-nine countries.

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

Drug patent expirations by year for MYRBETRIQ
Generic Entry Opportunity Date for MYRBETRIQ
Generic Entry Date for MYRBETRIQ*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for MYRBETRIQ
Synonyms for MYRBETRIQ
(2R)-2-(2-Aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic Acid Anilide
(R)-2-(2-aminothiazol-4-yl)-4-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}acetanilide
(R)-2-(2-aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetanilide
(R)-2-(2-aminothiazol-4-yl)-N-(4-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide
2-(2-amino-1,3-thiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide
2-(2-amino-1,3-thiazol-4-yl)-N-[4-[2-[[(2R)-2-hydroxy-2-phenylethyl]amino]ethyl]phenyl]acetamide
2-(2-amino-4-thiazolyl)-N-[4-[2-[[(2R)-2-hydroxy-2-phenylethyl]amino]ethyl]phenyl]acetamide
2-(2-aminothiazol-4-yl)-N-[4-[2-[[(2R)-2-hydroxy-2-phenyl-ethyl]amino]ethyl]phenyl]acetamide
2-(2-azanyl-1,3-thiazol-4-yl)-N-[4-[2-[[(2R)-2-oxidanyl-2-phenyl-ethyl]amino]ethyl]phenyl]ethanamide
2-Amino-N-[4-[2-[[(2R)-2-hydroxy-2-phenylethyl]amino]ethyl]phenyl]-4-thiazoleacetamide
223673-61-8
4-Thiazoleacetamide, 2-amino-N-(4-(2-(((2R)-2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)-
4CA-0821
928324-05-4
A816162
AB01565808_02
AJ-32308
AK159772
AKOS016340341
AN-3581
Betanis
Betmiga
CHEBI:65349
CHEMBL2095212
CS-0915
D09535
D0X5UN
DB08893
EX-A1050
FT-0672412
GTPL7445
HY-14773
KB-55049
KS-00000RKO
KS-1398
MFCD11100356
Mirabegron
Mirabegron (USAN/JAN)
Mirabegron (YM178)
Mirabegron [USAN:INN]
MolPort-019-994-262
MVR3JL3B2V
Myrbetriq (TN)
N-(4-(2-(2-hydroxy-2-phenylethylamino)ethyl)phenyl)-2-(2-aminothiazol-4-yl)acetamide
PBAPPPCECJKMCM-IBGZPJMESA-N
s4009
SCHEMBL904788
ST24048107
UNII-MVR3JL3B2V
W-5473
Y1125
YM 178
YM-178
YM178
ZINC1996784

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 ➤ Sign Up ➤ Sign Up
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 ➤ Sign Up ➤ Sign Up
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 Date
➤ Subscribe Extended-release Tablets 25 mg and 50 mg ➤ Subscribe ➤ Sign Up

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 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for MYRBETRIQ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00028 Denmark ➤ Sign Up
2013 00029 Denmark ➤ Sign Up PRODUCT NAME: MIRABEGRON OR SALTS THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
C0032 France ➤ Sign Up PRODUCT NAME: MIRABEGRON ET SES SELS; REGISTRATION NO/DATE: EU/1/12/809/001 20121220
90028-7 Sweden ➤ Sign Up PRODUCT NAME: MIRABEGRON ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/12/809/001 20121220
13/026 Ireland ➤ Sign Up PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
0599 Netherlands ➤ Sign Up PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20130107
2013 00028 Denmark ➤ Sign Up PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Merck
UBS
Deloitte
Harvard Business School
Covington
QuintilesIMS
Chubb
Moodys

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.