MYRBETRIQ Drug Patent Profile

When do Myrbetriq patents expire, and what generic alternatives are available?

Myrbetriq is a drug marketed by Apgdi and is included in two NDAs. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eleven patent family members in thirty countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Myrbetriq

A generic version of MYRBETRIQ was approved as mirabegron by LUPIN LTD on September 28^th, 2022.

Summary for MYRBETRIQ

International Patents:	111
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	51
Patent Applications:	217
Drug Prices:	Drug price information for MYRBETRIQ
Drug Sales Revenues:	Drug sales revenues for MYRBETRIQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYRBETRIQ
What excipients (inactive ingredients) are in MYRBETRIQ?	MYRBETRIQ excipients list
DailyMed Link:	MYRBETRIQ at DailyMed

See drug prices for MYRBETRIQ

See drug sales revenues for MYRBETRIQ

Recent Clinical Trials for MYRBETRIQ

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Seoul National University Hospital	Phase 2
Il-Yang Pharm. Co., Ltd.	Phase 2
Cedars-Sinai Medical Center	Phase 2

See all MYRBETRIQ clinical trials

Pharmacology for MYRBETRIQ

Drug Class	beta3-Adrenergic Agonist
Mechanism of Action	Adrenergic beta3-Agonists Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for MYRBETRIQ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYRBETRIQ	Extended-release Tablets	mirabegron	50 mg	202611	6	2016-06-28

US Patents and Regulatory Information for MYRBETRIQ

MYRBETRIQ is protected by ten US patents and two FDA Regulatory Exclusivities.

Patents protecting MYRBETRIQ

FDA Regulatory Exclusivity protecting 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 GRANULES	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	213801-001	Mar 25, 2021		RX	Yes	Yes
Apgdi	MYRBETRIQ GRANULES	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	213801-001	Mar 25, 2021		RX	Yes	Yes
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	AB	RX	Yes	Yes
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	AB	RX	Yes	Yes
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	AB	RX	Yes	Yes
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	AB	RX	Yes	Yes

Expired US Patents for MYRBETRIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012

EU/EMA Drug Approvals for MYRBETRIQ

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Astellas Pharma Europe B.V.	Betmiga	mirabegron	EMEA/H/C/002388 Symptomatic treatment of urgency.Increased micturition frequency and / or urgency incontinence as may occur in adult patients with overactive-bladder syndrome.	Authorised	no	no	no	2012-12-20

International Patents for MYRBETRIQ

When does loss-of-exclusivity occur for MYRBETRIQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Croatia

Cyprus

Denmark

European Patent Office

Japan

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MYRBETRIQ around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	331834
Cyprus	1113670
World Intellectual Property Organization (WIPO)	2009057685
European Patent Office	1440969
Japan	WO2003037881	酢酸アニリド誘導体のα型又はβ型結晶
Mexico	PA02001267	COMPOSICION FARMACEUTICA ESTABLE PARA USO ORAL. (STABLE MEDICINAL COMPOSITIONS FOR ORAL USE.)

Supplementary Protection Certificates for MYRBETRIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1559427	2013/026	Ireland		PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427	C 2013 020	Romania		PRODUCT NAME: MIRABEGRON SAU O SARE A ACESTUIA(2-(2-AMINO-1,3-TRIAZOL-4-IL)-N-[4-(2-{[(2R)-2-HIDROXI9/014; DATE OF NATIONAL AUTHORISATION: 20121220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/809/001 - EU/1/12/809/014; DATE OF FIRST AUTHORISATION IN EEA: 20121220 -2-FENILETIL]AMINO}ETIL)FENIL]ACETAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/12/809/001 - EU/1/12/80
1559427	1390028-7	Sweden		PRODUCT NAME: MIRABEGRON ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/12/809/001 20121220
1559427	C300599	Netherlands		PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1028111	C300598	Netherlands		PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427	122013000047	Germany		PRODUCT NAME: MIRABEGRON ODER EIN SALZ DAVON; NAT. REGISTRATION NO/DATE: EU /1/12/809/001-014 20121220; FIRST REGISTRATION: EU EU/1/12/809/001-014 20121220