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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
McKinsey
Fuji
Teva
Fish and Richardson
Cerilliant
QuintilesIMS
AstraZeneca
Dow

Generated: September 26, 2018

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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.

There are seventeen 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 202611-001 Jun 28, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
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
0130015 00094 Estonia ➤ Try a Free Trial PRODUCT NAME: MIRABEGROON;REG NO/DATE: K(2012)9945 (LOPLIK) 20.12.2012
1559427/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: SWISSMEDIC 62755 19.05.2014
00598 Netherlands ➤ Try a Free Trial PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION 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:

Chubb
McKinsey
Fuji
Teva
Fish and Richardson
Cerilliant
QuintilesIMS
AstraZeneca
Dow

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.