Viewing data from:

MYRBETRIQ GRANULES

NDA

MIRABEGRON | N213801 | ASTELLAS PHARMA GLOBAL DEVELOPMENT INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)TodayPED (+6 mo)

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

10058536

Sep. 30, 2036

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

101 trials from ClinicalTrials.gov — 1 recruiting, 79 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists NCT03049462	Phase 1	Recruiting	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	100	2017-03-13 → 2026-09-30
A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder NCT02045862	Phase 3	Completed	Astellas Pharma Europe B.V.	1,829	2014-03-17 → 2016-09-08
Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine NCT01964183	Phase 4	Completed	Astellas Pharma Inc	24	2013-06 → 2013-08
Study of Behavioral Modification Program and Mirabegron to Improve Urinary Urgency in Multiple Sclerosis NCT02086188	Phase 4	Completed	Theodore R. Brown, MD MPH	28	2014-05 → 2019-06
A Study to Evaluate How Mirabegron Enters and Leaves the Bloodstream According to Age and Sex NCT01285596	Phase 1	Completed	Astellas Pharma Inc	75	2009-03 → 2009-11
A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder NCT01340027	Phase 2	Completed	Astellas Pharma Europe B.V.	1,307	2011-03-29 → 2012-06-28
Mirabegron and Urinary Urgency Incontinence NCT02495389	Phase 4	Completed	Loyola University	84	2015-01-28 → 2019-01-29
Pharmacological Activation of Brown Adipose Tissue Metabolism NCT02811289	N/A	Completed	Université de Sherbrooke	22	2016-08-05 → 2018-07-05
Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain NCT02744430	Phase 2	Completed	Baylor College of Medicine	33	2017-07-22 → 2019-10-31
Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.NCT02294396	Phase 4	Completed	Astellas Pharma Inc	649	2014-10-28 → 2016-09-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$2.21

per ml

Lowest NADAC/Unit

$2.21

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00469502099MYRBETRIQ ER 8 MG/ML SUSP	$2.21	ML	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$139.30

Highest Price

$139.30

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00469-5020-99MYRBETRIQ ORAL SUSP	$139.30	FSS	Astellas Pharma U.S., Inc.	09/29/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain38 active DMFs1 inactive

36 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDMIRABEGRON [ROUTE CODE "MG"]

DMF 280712014

DR REDDYS LABORATORIES LTDMIRABEGRON [PRODUCT CODE: AEB]

DMF 283922014

DR REDDYS LABORATORIES LTDMIRABEGRON [FORM - AMORPHOUS]

DMF 290642015

MICRO LABS LTDMIRABEGRON

DMF 297342015

MEGAFINE PHARMA P LTDMIRABEGRON DRUG SUBSTANCE

DMF 297732015

LUPIN MANUFACTURING SOLUTIONS LTDMIRABEGRON

DMF 299252015

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDMIRABEGRON

DMF 300302015

ALIVUS LIFE SCIENCES LTDMIRABEGRON

DMF 300652016

APITORIA PHARMA PRIVATE LTDMIRABEGRON

DMF 300862015

ZYDUS LIFESCIENCES LTDMIRABEGRON

DMF 301052016

SOLARA ACTIVE PHARMA SCIENCES LTDMIRABEGRON

DMF 301692016

HETERO DRUGS LTDMIRABEGRON (FORM-B)

DMF 302912016

JIANGXI SYNERGY PHARMACEUTICAL CO LTDMIRABEGRON

DMF 316612017

SYNTHON BVMIRABEGRON

DMF 324402018

DELMAR CHEMICALS INCMIRABEGRON

DMF 329292018

PIRAMAL PHARMA LTDMIRABEGRON

DMF 332812018

UNICHEM LABORATORIES LTDMIRABEGRON

DMF 335032019

JUBILANT BIOSYS LTDMIRABEGRON

DMF 335162019

COHANCE LIFESCIENCES LTDMIRABEGRON

DMF 338212019

BIOCON LTDMIRABEGRON

DMF 351172020

VIWIT PHARMACEUTICAL CO LTDMIRABEGRON

DMF 359802021

MSN LABORATORIES PRIVATE LTDMIRABEGRON (a-FORM)

DMF 366822022

VASUDHA PHARMA CHEM LTDMIRABEGRON IH

DMF 366852022

CIPLA LTDMIRABEGRON

DMF 367782022

METROCHEM API PRIVATE LTDMIRABEGRON

DMF 369732022

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDMIRABEGRON

DMF 378002022

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDMIRABEGRON

DMF 381562023

CHEMO SMS ENTERPRISE SLMIRABEGRON

DMF 386122023

NEULAND LABORATORIES LTDMIRABEGRON

DMF 387702023

AMOLI ORGANICS PVT LTDMIRABEGRON

DMF 388252023

MACLEODS PHARMACEUTICALS LTDMIRABEGRON

DMF 395262024

MEHTA API PVT LTDMIRABEGRON EP

DMF 404022024

AMI LIFESCIENCES PRIVATE LTDMIRABEGRON

DMF 404212024

SYNTHIMED LABS PRIVATE LTDMIRABEGRON

DMF 413902025

RAKSHIT DRUGS PRIVATE LTDMIRABEGRON

DMF 421002025

AARTI PHARMALABS LTDMIRABEGRON

DMF 425902025

CAMBREX PROFARMACO MILANO SRLMIRABEGRON

DMF 436882026

SWATI SPENTOSE PRIVATE LIMITEDMIRABEGRON

DMF 437542026

DR REDDYS LABORATORIES LTDInactiveMIRABEGRON PREMIX

DMF 304132016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 30, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 8MG/ML

RLDAB

1 patent0 exclusivities▴

FOR SUSPENSION, EXTENDED RELEASE;ORAL | Approved: Mar 25, 2021

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10058536	Mar 31, 2036PED: Sep 30, 2036	PED	—	Yes		—