myrbetriq granules Drug Patent Profile

When do Myrbetriq Granules patents expire, and when can generic versions of Myrbetriq Granules launch?

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.

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

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

FDA Regulatory Exclusivity protecting myrbetriq granules

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 GRANULES	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	213801-001	Mar 25, 2021		RX	Yes	Yes					Y

EU/EMA Drug Approvals for myrbetriq granules

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 granules

See the table below for patents covering myrbetriq granules around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2002344419
Brazil	9804500	derivado de amida, referida composição farmacêutica e agente terapêutico.
Mexico	PA04003936	CRISTAL EN FORMA ALFA O EN FORMA BETA DE DERIVADO DE ACETANILIDA. (alpha-FORM OR ß-FORM CRYSTAL OF ACETANILIDE DERIVATIVE.)

Supplementary Protection Certificates for myrbetriq granules

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1028111	300598	Netherlands		PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427	1390028-7	Sweden		PRODUCT NAME: MIRABEGRON ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/12/809/001 20121220
1559427	132013902166933	Italy		PRODUCT NAME: MIRABEGRON(BETMIGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/809/014, 20121220