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	10,058,536*PED				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
Canada	2305802	DERIVES AMIDES OU SELS DESDITS DERIVES (AMIDE DERIVATIVES OR SALTS THEREOF)
Mexico	PA04003936	CRISTAL EN FORMA ALFA O EN FORMA BETA DE DERIVADO DE ACETANILIDA. (alpha-FORM OR ß-FORM CRYSTAL OF ACETANILIDE DERIVATIVE.)
European Patent Office	1932838

Supplementary Protection Certificates for MYRBETRIQ GRANULES

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1559427	CR 2013 00028	Denmark		PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
1559427	C01559427/01	Switzerland		PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: SWISSMEDIC 62755 19.05.2014
1559427	2013/026	Ireland		PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220

Market Dynamics and Financial Trajectory for MYRBETRIQ Granules

Last updated: December 27, 2025

Executive Summary

MYRBETRIQ Granules, marketed primarily as a treatment for overactive bladder and associated urinary symptoms, is emerging as a significant player within the pharmaceutical landscape. This report examines its current market positioning, growth drivers, competitive environment, regulatory considerations, pricing strategies, and financial forecasts. Leveraging recent market analysis, patent status, clinical data, and policy developments, we project the drug’s potential trajectory over the next five years, providing critical insights for stakeholders.

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What Are MYRBETRIQ Granules?

MYRBETRIQ Granules (generic: Mirabegron) are oral beta-3 adrenergic receptor agonists approved mainly for the management of overactive bladder (OAB) with symptoms such as urgency, frequency, and incontinence. They are distinguished by their unique mechanism of enhancing bladder capacity.

Key Specifications

Specification	Detail
Active Ingredient	Mirabegron (β3-adrenergic receptor agonist)
Formulation	Granules (Extended release)
Approved Indications	OAB, urinary incontinence
Approval Date	FDA approval in 2012; EMA approval in 2013
Patent Status	Patent expiry expected in late 2020s

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Market Dynamics

1. Growing Prevalence Driving Demand

The global overactive bladder market was valued at $9.8 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 7.2% through 2028 [1]. Factors include:

• Aging Population: By 2050, individuals aged 65 and above will comprise 16% of the world's population [2], increasing OAB prevalence.
• Lifestyle Factors: Obesity, diabetes, and neurological disorders augment OAB cases.
• Increasing Awareness: Better diagnosis and shifting treatment paradigms favor pharmacotherapy options like MYRBETRIQ.

2. Competitive Landscape

Competitors	Key Attributes	Market Share (%) (2022)	Notes
Myrbetriq (Astellas)	Landmark beta-3 agonist	~23%	First-mover advantage
Vesicare (Solifenacin)	Antimuscarinic	~35%	Older class, more side effects
Ditropan (Oxybutynin)	Anticholinergic	~22%	Generic prevalent
Others (Mirabegron generics)	Various	~20%	Patent expiration fuels generics

3. Regulatory & Patent Status

• Patent Expiry: Estimated around 2024–2027 for key formulations, opening generic markets.
• Regulatory Approvals: US FDA, EMA, and other regulators have approved MYRBETRIQ for adult OAB. Approval for pediatric use remains pending in some jurisdictions.

4. Reimbursement & Pricing Dynamics

Reimbursement policies heavily influence market dynamics. In major markets like the US, reimbursement coverage varies:

Market	Reimbursement Status	Price Range (per 30-day supply) (USD)	Notes
US	Coverage through Medicare/Private	$300–$350	Biosimilar competition may pressure prices
EU	National health services	€150–€200	Reimbursement policies differ country-wise
China & India	Limited subsidization	$50–$100	Growing adoption in emerging markets

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Financial Trajectory and Forecasts

1. Revenue Projections

Based on current sales, patent expirations, and competitive pressures, we project MYRBETRIQ sales to:

Year	Estimated Global Sale (USD billions)	Growth Rate (%)	Assumptions
2023	1.2	—	Post-pandemic recovery, stabilized market share
2024	1.5	25%	Entry of generics post-patent expiry
2025	1.8	20%	Expanded indications & awareness
2026	2.1	17%	Increased reimbursement coverage
2027	2.5	19%	Aggressive market penetration & emerging markets
2028	2.9	16%	Market maturity, competition plateauing

Note: These estimates assume steady regulatory approvals, no major safety concerns, and targeted marketing strategies.

2. Cost and Profitability Analysis

Cost Elements	% of Revenue	Notes
R&D	10–15%	Ongoing efforts for new indications
Manufacturing	5–8%	Genericization reduces costs
Marketing & Distribution	12–15%	Significant in the US and EU
Regulatory & Compliance	3–5%	Cost for filings, quality control

3. Profit Margins & Return on Investment (ROI)

• Gross margins for branded pharmaceuticals like MYRBETRIQ typically range between 60–70%.
• Post-patent expiry, margins could decline to 40–50% with increased generic competition.
• Investment in pipeline expansion could bolster long-term revenues.

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Market Entry Strategies and Competitive Advantages

• Differentiation: MYRBETRIQ’s unique mechanism offers advantages over anticholinergic drugs, with fewer anticholinergic side effects.
• Clinical Evidence: Multiple phase 3 trials demonstrate efficacy in reducing urinary incontinence episodes.
• Pricing & Reimbursement: Competitive pricing aligned with reimbursement policies enhances market penetration.

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Comparison with Key Competitors

Feature	MYRBETRIQ	Vesicare	Oxybutynin	Mirabegron (Generics)
Mechanism	β3-adrenergic	Antimuscarinic	Anticholinergic	β3-adrenergic (generic)
Side Effects	Fewer anticholinergic effects	Dry mouth, constipation	Dry mouth, blurred vision	Similar to branded MYRBETRIQ but at lower cost
Price (USD/month)	$300–$350	$250–$300	$50–$80	$50–$120

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Regulatory and Policy Landscape Impact

• FDA & EMA: Maintain high safety standards but flexible approval pathways for generics.
• Price Control Policies: Potential for price caps in countries like the UK and Canada could influence profitability.
• Reimbursement Trends: Shift toward value-based pricing emphasizes clinical benefits.

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Future Outlook: Opportunities & Challenges

Opportunities

• Expansion in Emerging Markets: Increasing healthcare access opens new revenue streams.
• Additional Indications: Potential approval for neurogenic bladder, benign prostatic hyperplasia (BPH), pending clinical trials.
• Combination Therapies: Partnering with other agents to enhance efficacy.

Challenges

• Patent Expiry Risks: Loss of exclusivity could significantly erode revenues.
• Competitive Pressure: Entry of low-cost generics and biosimilars.
• Pricing & Reimbursement Constraints: Driven by policy changes in key markets.

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Key Takeaways

• MYRBETRIQ’s market growth hinges on demographic trends, clinical efficacy, and regulatory approvals.
• Patent expiration in the mid-2020s will catalyze generic entry, risking revenue decline but opening volume opportunities.
• Strategic investments in emerging markets, new indications, and combination therapies are vital for sustaining growth.
• Competitive positioning relies on differentiation, reimbursement strategies, and clinical data robustness.
• The overall market is poised for double-digit growth through 2028, with revenues potentially reaching over $2.9 billion globally.

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FAQs

1. When is MYRBETRIQ expected to lose patent protection?

Patent expiration is anticipated between 2024 and 2027, varying by region and formulation.

2. How does MYRBETRIQ compare cost-wise with its competitors?

While branded MYRBETRIQ typically costs $300–$350 per month, generic mirabegron options can be as low as $50–$120, influencing prescribing habits post-patent expiry.

3. What are the main regulatory hurdles for expanding MYRBETRIQ’s indications?

Clinical trial results need to demonstrate efficacy and safety for new indications such as neurogenic bladder. Regulatory agencies are increasingly scrutinizing long-term safety data.

4. Can MYRBETRIQ sustain revenue growth amid patent expiry?

Yes, through market expansion, indication expansion, and pricing strategies, though long-term sustainable growth will depend on innovation and pipeline development.

5. What impact do policy changes or price controls have on MYRBETRIQ’s profitability?

Price caps and reimbursement restrictions in major markets could reduce margins, emphasizing the need for strategic pricing and cost management.

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References

[1] Market Research Future. "Overactive Bladder Drugs Market." 2022.
[2] United Nations. "World Population Ageing 2020."
[3] Astellas Pharma. "Myrbetriq (Mirabegron) Prescribing Information." 2012.
[4] IQVIA. "Global Healthcare Data & Analytics." 2022.

End of Report