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Generated: January 18, 2019

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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 seven 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 eighteen patent family members in twenty-nine countries.

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

Pharmacology for mirabegron
Synonyms for mirabegron
(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 (USAN/JAN)
Mirabegron (YM178)
Mirabegron [USAN:INN]
MolPort-019-994-262
MVR3JL3B2V
Myrbetriq
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 mirabegron

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 202611-002 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 ➤ 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 202611-001 Jun 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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 202611-002 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 ➤ 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 mirabegron

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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Supplementary Protection Certificates for mirabegron

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0599 Netherlands ➤ Sign Up PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20130107
7 Finland ➤ Sign Up
218 Luxembourg ➤ Sign Up PRODUCT NAME: MIRABEGRON OU UN DE SES SELS
C0032 France ➤ Sign Up PRODUCT NAME: MIRABEGRON ET SES SELS; REGISTRATION NO/DATE: EU/1/12/809/001 20121220
00599 Netherlands ➤ Sign Up PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
0598 Netherlands ➤ Sign Up PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
8 5014-2013 Slovakia ➤ Sign Up PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: EU/1/12/809/001 - EU/1/12/809/014 20121220
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Farmers Insurance
Medtronic
Cerilliant
Argus Health
Healthtrust
McKinsey
US Army
Express Scripts

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