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Generated: June 17, 2019

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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 nineteen patent family members in twenty-nine countries.

The generic ingredient in MYRBETRIQ is mirabegron. There are nineteen 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
DB08893
EX-A1050
FT-0672412
GTPL7445
HMS3714I09
HY-14773
KB-55049
KS-00000RKO
KS-1398
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
SB17018
SCHEMBL904788
ST24048107
SW220301-1
UNII-MVR3JL3B2V
W-5473
Y1125
YM 178
YM 178; Betanis
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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Paragraph IV (Patent) Challenges for MYRBETRIQ
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 25 mg and 50 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for MYRBETRIQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1559427 C20130015 00094 Estonia ➤ Sign Up PRODUCT NAME: MIRABEGROON;REG NO/DATE: K(2012)9945 (LOPLIK) 20.12.2012
1559427 2013C/040 Belgium ➤ Sign Up PRODUCT NAME: MIRABEGRON OU L'UN DES SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/12/809/001 20130107
1559427 1390028-7 Sweden ➤ Sign Up PRODUCT NAME: MIRABEGRON ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/12/809/001 20121220
1559427 33/2013 Austria ➤ Sign Up PRODUCT NAME: MIRABEGRON ODER DESSEN SALZE; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1028111 300598 Netherlands ➤ Sign Up PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427 SPC/GB13/035 United Kingdom ➤ Sign Up PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTERED: UK EU/1/12/809/001-014 20130107
1559427 457 Finland ➤ Sign Up
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Chinese Patent Office
Cantor Fitzgerald
McKesson
Daiichi Sankyo
Fish and Richardson

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.