Details for New Drug Application (NDA): 202611

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NDA 202611 describes MYRBETRIQ, which is a drug marketed by Apgdi and is included in two NDAs. It is available from three suppliers. There are ten patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MYRBETRIQ profile page.

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.

Summary for 202611

Tradename:	MYRBETRIQ
Applicant:	Apgdi
Ingredient:	mirabegron
Patents:	9

Pharmacology for NDA: 202611

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

Suppliers and Packaging for NDA: 202611

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611	NDA	Astellas Pharma US, Inc.	0469-2601	0469-2601-07	4 CARTON in 1 TRAY (0469-2601-07) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611	NDA	Astellas Pharma US, Inc.	0469-2601	0469-2601-30	1 BOTTLE in 1 CARTON (0469-2601-30) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	25MG
Approval Date:	Jun 28, 2012	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 25, 2024
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Mar 25, 2024
Regulatory Exclusivity Use:	TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 3 YEARS AND OLDER AND WEIGHING 35 KILOGRAMS OR MORE
Patent:	10,842,780*PED	Patent Expiration:	Mar 28, 2030	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 202611

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	6,562,375	⤷ Subscribe
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	7,750,029	⤷ Subscribe
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	6,562,375	⤷ Subscribe
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	6,699,503	⤷ Subscribe
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	7,750,029	⤷ Subscribe
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	6,699,503	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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