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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 one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the MYRBETRIQ profile page.

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

Summary for NDA: 202611

Tradename:
MYRBETRIQ
Applicant:
Apgdi
Ingredient:
mirabegron
Patents:6

Pharmacology for NDA: 202611

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 0469-2601-30 1 BOTTLE in 1 CARTON (0469-2601-30) > 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL 202611 NDA Astellas Pharma US, Inc. 0469-2601 0469-2601-71 10 BLISTER PACK in 1 CARTON (0469-2601-71) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25MG
Approval Date:Jun 28, 2012TE:RLD:No
Patent:6,346,532Patent Expiration:Mar 27, 2022Product Flag?YSubstance Flag?YDelist Request?
Patent:6,562,375Patent Expiration:Aug 1, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:7,342,117Patent Expiration:Nov 4, 2023Product Flag?Substance Flag?YDelist Request?

Expired Orange Book Patents for NDA: 202611

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-001Jun 28, 20126,699,503► subscribe
Apgdi
MYRBETRIQ
mirabegron
TABLET, EXTENDED RELEASE;ORAL202611-002Jun 28, 20126,699,503► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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