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Last Updated: April 18, 2024

Mirabegron - Generic Drug Details

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What are the generic sources for mirabegron and what is the scope of freedom to operate?

Mirabegron is the generic ingredient in three branded drugs marketed by Apgdi, Alkem Labs Ltd, Lupin Ltd, Sawai Usa, and Zydus Pharms, and is included in six NDAs. There are eight 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 twenty-four patent family members in thirty-one countries.

There are nineteen drug master file entries for mirabegron. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for mirabegron

International Patents:	124
US Patents:	8
Tradenames:	3
Applicants:	5
NDAs:	6
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	135
Patent Applications:	102
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for mirabegron
What excipients (inactive ingredients) are in mirabegron?	mirabegron excipients list
DailyMed Link:	mirabegron at DailyMed

Recent Clinical Trials for mirabegron

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

Sponsor	Phase
The University of Texas Medical Branch, Galveston	Early Phase 1
University of California, San Diego	Phase 1
Benha University	N/A

See all mirabegron clinical trials

Generic filers with tentative approvals for MIRABEGRON

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	50MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for mirabegron

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 MIRABEGRON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYRBETRIQ GRANULES	Granules for Extended-release Suspension	mirabegron	8 mg/mL	213801	1	2024-01-12
MYRBETRIQ	Extended-release Tablets	mirabegron	50 mg	202611	6	2016-06-28

US Patents and Regulatory Information for mirabegron

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	MIRABEGRON	mirabegron	TABLET, EXTENDED RELEASE;ORAL	209485-001	Sep 28, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apgdi	MYRBETRIQ GRANULES	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	213801-001	Mar 25, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for mirabegron

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

EU/EMA Drug Approvals for mirabegron

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for mirabegron

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1559427	REMEDE POUR VESSIE HYPERACTIVE COMPRENANT UN DERIVE ANILIDE DE L'ACIDE ACETIQUE EN TANT QU'INGREDIENT ACTIF (REMEDY FOR OVERACTIVE BLADDER COMPRISING ACETIC ACID ANILIDE DERIVATIVE AS THE ACTIVE INGREDIENT)	⤷ Try a Trial
Hungary	E046729		⤷ Try a Trial
Japan	WO2010038690	放出制御医薬組成物	⤷ Try a Trial
Japan	WO2009057685	過活動膀胱治療用医薬組成物	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for mirabegron

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1559427	168 5014-2013	Slovakia	⤷ Try a Trial	PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: EU/1/12/809/001 - EU/1/12/809/014 20121220
1559427	C300599	Netherlands	⤷ Try a Trial	PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427	132013902166933	Italy	⤷ Try a Trial	PRODUCT NAME: MIRABEGRON(BETMIGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/809/014, 20121220
1028111	300598	Netherlands	⤷ Try a Trial	PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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