MYRBETRIQ GRANULES Drug Patent Profile

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

Myrbetriq Granules is a drug marketed by Apgdi and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in twenty-three countries.

The generic ingredient in MYRBETRIQ GRANULES 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 Granules

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

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Summary for MYRBETRIQ GRANULES

International Patents:	40
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Patent Applications:	217
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYRBETRIQ GRANULES
DailyMed Link:	MYRBETRIQ GRANULES at DailyMed

Drug patent expirations by year for MYRBETRIQ GRANULES

Pharmacology for MYRBETRIQ GRANULES

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 GRANULES

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYRBETRIQ GRANULES	Granules for Extended-release Suspension	mirabegron	8 mg/mL	213801	1	2024-01-12

US Patents and Regulatory Information for MYRBETRIQ GRANULES

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

Patents protecting MYRBETRIQ GRANULES

Pharmaceutical composition containing mirabegron
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

.alpha.-form or .beta.-form crystal of acetanilide derivative
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting MYRBETRIQ GRANULES

NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up

PEDIATRIC EXCLUSIVITY
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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
Apgdi	MYRBETRIQ GRANULES	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	213801-001	Mar 25, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apgdi	MYRBETRIQ GRANULES	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	213801-001	Mar 25, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apgdi	MYRBETRIQ GRANULES	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	213801-001	Mar 25, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Apgdi	MYRBETRIQ GRANULES	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	213801-001	Mar 25, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apgdi	MYRBETRIQ GRANULES	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	213801-001	Mar 25, 2021		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

EU/EMA Drug Approvals for MYRBETRIQ GRANULES

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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 MYRBETRIQ GRANULES

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

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Country	Patent Number	Title	Estimated Expiration
Japan	WO2003037881	酢酸アニリド誘導体のα型又はβ型結晶	⤷ Sign Up
Spain	2221204		⤷ Sign Up
China	1243740		⤷ Sign Up
Serbia	59626	FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI MIRABEGRON (PHARMACEUTICAL COMPOSITION CONTAINING MIRABEGRON)	⤷ Sign Up
Poland	218982		⤷ Sign Up
European Patent Office	2298752	Forme crystalline alpha ou beta d'un derivé d'acetanilide (Alpha-form or beta-form crystal of acetanilide derivative)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MYRBETRIQ GRANULES

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1559427	SPC/GB13/035	United Kingdom	⤷ Sign Up	PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTERED: UK EU/1/12/809/001-014 20130107
1028111	300598	Netherlands	⤷ Sign Up	PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427	33/2013	Austria	⤷ Sign Up	PRODUCT NAME: MIRABEGRON ODER DESSEN SALZE; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
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	C300599	Netherlands	⤷ Sign Up	PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427	300599	Netherlands	⤷ Sign Up	PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20130107
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description