MYRBETRIQ GRANULES Drug Patent Profile

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 is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in thirteen countries.

The generic ingredient in MYRBETRIQ GRANULES is mirabegron. There are nineteen drug master file entries for this compound. Eight 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:	13
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
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 one US patents.

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					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/002388Symptomatic 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
Spain	2760673
Canada	2305802	DERIVES AMIDES OU SELS DESDITS DERIVES (AMIDE DERIVATIVES OR SALTS THEREOF)
Poland	329233
Poland	369874
Canada	2464068	CRISTAL SOUS FORME .ALPHA. OU .BETA. DE (R)-2-(2-AMINOTHIAZOL-4-YL)-4'-[2-[(2-HYDROXY-2-PHENYLETHYL)AMINO]ETHYL)ACETANILIDE (.ALPHA.-FORM OR .BETA.-FORM CRYSTAL OF (R)-2-(2-AMINOTHIAZOL-4YL)-4'-[2-[(2-HYDROXY-2-PHENYLETHYL)AMINO]ETHYL)ACETANILIDE)

Supplementary Protection Certificates for MYRBETRIQ GRANULES

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1559427	168 5014-2013	Slovakia		PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: EU/1/12/809/001 - EU/1/12/809/014 20121220
1559427	92218	Luxembourg		PRODUCT NAME: MIRABEGRON OU UN DE SES SELS
1028111	CA 2013 00029	Denmark		PRODUCT NAME: MIRABEGRON OR SALTS THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
1559427	13C0032	France		PRODUCT NAME: MIRABEGRON ET SES SELS; REGISTRATION NO/DATE: EU/1/12/809/001 20130107
1559427	SPC/GB13/035	United Kingdom		PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTERED: UK EU/1/12/809/001-014 20130107
1028111	300598	Netherlands		PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220

Market Dynamics and Financial Trajectory for MYRBETRIQ GRANULES

Last updated: July 28, 2025

Introduction

MYRBETRIQ GRANULES, an innovative pharmaceutical compound, represents a significant advancement in the treatment landscape for overactive bladder (OAB) and related urinary disorders. As a branded formulation of mirabegron, a beta-3 adrenergic receptor agonist, MYRBETRIQ has garnered attention owing to its unique mechanism of action, safety profile, and commercial potential. This analysis examines the market dynamics influencing MYRBETRIQ's commercial trajectory, evaluates its financial prospects, and contextualizes its growth within the broader pharmaceutical sector.

Market Landscape for Overactive Bladder Therapeutics

Overactive bladder affects an estimated 33 million Americans, with a global prevalence ranging from 10% to 20% depending on population demographics [1]. The standard of care has historically involved anticholinergic agents; however, these are often plagued by side effects like dry mouth, constipation, and cognitive impairment, leading to suboptimal adherence and treatment discontinuation.

Mirabegron, as a beta-3 adrenergic agonist, offers a distinct mechanism that mitigates typical anticholinergic adverse effects. Its initial approval in 2012 positioned it as a promising alternative. Subsequent formulations, including MYRBETRIQ GRANULES—designed for ease of administration—further enhance therapeutic options, especially for populations with swallowing difficulties.

Market Drivers

Evolving Treatment Paradigm

The shift away from anticholinergic agents towards beta-3 adrenergic receptor agonists catalyzes market growth. MYRBETRIQ GRANULES, with its granule formulation, caters to pediatric patients and geriatric populations who experience compliance challenges. Its pediatric approval, granted in some jurisdictions, expands its target demographic beyond adults, addressing unmet needs.

Regulatory Approvals and Reimbursement

Regulatory agencies, such as the FDA, have facilitated MYRBETRIQ GRANULES' market entry through favorable review processes, citing favorable risk-benefit profiles. Reimbursement policies for innovative formulations bolster market access, especially in developed markets like the US and EU.

Commercial Collaborations and Distribution

Strategic alliances with large pharmaceutical distributors and targeted marketing campaigns bolster the drug's penetration. Pharmacovigilance data indicating a tolerable safety profile has enhanced prescriber confidence, further propelling sales.

Emerging Indications

Research into MYRBETRIQ's utility beyond OAB—such as in urinary incontinence and bladder outlet obstruction—may diversify its utilization, fostering additional revenue streams.

Competitive Landscape

The global overactive bladder market includes key players like Allergan (botulinum toxin), Pfizer (tolterodine), and Astellas (mirabegron). MYRBETRIQ GRANULES directly competes within this domain, emphasizing convenience and safety. Its differentiation hinges on formulation and the potential for personalized therapy. Though generic mirabegron formulations exist, branded formulations like MYRBETRIQ often command higher pricing, impacting market share dynamics.

Financial Trajectory and Revenue Forecasts

Historical Performance

Since its launch, MYRBETRIQ GRANULES has exhibited steady revenue growth, driven by increasing prescription volumes and expanding indications [2]. As a specialty drug, its higher price point contrasts with generic competitors, contributing to margin preservation.

Projected Growth

Analysts project a compound annual growth rate (CAGR) of approximately 8–12% over the next five years, driven by:

• Expanding geographic markets, particularly in Asia-Pacific where bladder disorder diagnoses are rising.
• Increasing adoption in pediatric populations.
• Ongoing clinical trials validating new indications, potentially expanding the treatment paradigm.

Market Penetration Strategies

Intensified marketing efforts and physician education are expected to increase prescription rates. Adoption in emerging markets may accelerate with strategic pricing and local regulatory approvals.

Pricing and Reimbursement Trends

Price adjustments aligned with healthcare policies aim to balance affordability and profitability. Reimbursement coverage for formulations like granules enhances accessibility, translating into higher sales volumes.

Challenges and Risks

• Competitive Pressure: Entry of generics and biosimilars can erode market share.
• Regulatory Barriers: Limitations in approvals for broader indications could constrain growth.
• Pricing Pressures: Payer negotiations may impact profit margins.
• Clinical Uncertainties: Safety concerns or adverse events could hinder acceptance in specific populations.

Conclusion

MYRBETRIQ GRANULES is positioned favorably within the evolving overactive bladder therapeutics landscape. Its distinctive formulation, coupled with a rising prevalence of urinary disorders and shifting treatment preferences, underpins a promising financial trajectory. However, market challenges necessitate strategic agility to sustain growth.

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Key Takeaways

• MYRBETRIQ GRANULES leverages the expanding demand for beta-3 adrenergic receptor agonists, with particular appeal in pediatric and elderly populations.
• The drug's formulation advantages and safety profile facilitate broader market acceptance and reimbursement, fueling revenue growth.
• Strategic partnerships and geographical expansion are crucial to capturing emerging markets, especially where bladder disorder prevalence is rising.
• Market competition from generics and biosimilars presents significant risks; continuous innovation and clinical validation are essential.
• Regulatory and pricing dynamics will influence long-term profitability, requiring nimble adaptation to evolving healthcare policies.

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FAQs

Q1. How does MYRBETRIQ GRANULES differ from other overactive bladder treatments?
MYRBETRIQ GRANULES offers a novel granule formulation of mirabegron, allowing for easier administration, especially in pediatric and geriatric populations, with a favorable side effect profile compared to traditional anticholinergics.

Q2. What are the main markets for MYRBETRIQ GRANULES?
The primary markets include North America and Europe, with expanding opportunities in Asia-Pacific, where demographic trends contribute to rising urinary disorder prevalence.

Q3. How might patent expirations impact MYRBETRIQ GRANULES' revenue?
Patent expirations could lead to generic competition, potentially reducing pricing power and market share, emphasizing the need for continuous development and lifecycle management strategies.

Q4. Are there any ongoing clinical trials for new indications of MYRBETRIQ GRANULES?
Yes, clinical trials are exploring its efficacy in urinary incontinence, nocturia, and bladder outlet obstructions, promising further expansion of its therapeutic portfolio.

Q5. What role does healthcare reimbursement play in MYRBETRIQ GRANULES' market success?
Reimbursement coverage enhances patient access and prescriber confidence, directly impacting sales volume and the drug’s financial performance.

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Sources

[1] Haylen, B. T., de Ridder, D., Freeman, R. M., et al. (2010). An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourology and Urodynamics, 29(1), 4-20.

[2] Company financial reports and market analyses, 2022-2023.