Mirabegron - Generic Drug Details

What are the generic sources for mirabegron and what is the scope of freedom to operate?

Mirabegron is the generic ingredient in three branded drugs marketed by Apgdi, Alkem Labs Ltd, Apotex, Ascent Pharms Inc, Lupin Ltd, MSN, Qilu, Sawai Usa, and Zydus Pharms, and is included in eleven NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Mirabegron has sixty-six patent family members in twenty-six countries.

There are nineteen drug master file entries for mirabegron. Eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for mirabegron

International Patents:	66
US Patents:	6
Tradenames:	3
Applicants:	9
NDAs:	11
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	157
Patent Applications:	1,087
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for mirabegron
What excipients (inactive ingredients) are in mirabegron?	mirabegron excipients list
DailyMed Link:	mirabegron at DailyMed

Recent Clinical Trials for mirabegron

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
VA Office of Research and Development	PHASE4
University of Alabama at Birmingham	NA
Bir Hospital	PHASE3

See all mirabegron clinical trials

Generic filers with tentative approvals for MIRABEGRON

Applicant	Application No.	Strength	Dosage Form
		50MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for mirabegron

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

Anatomical Therapeutic Chemical (ATC) Classes for mirabegron

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for MIRABEGRON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYRBETRIQ GRANULES	Granules for Extended-release Suspension	mirabegron	8 mg/mL	213801	1	2024-01-12
MYRBETRIQ	Extended-release Tablets	mirabegron	50 mg	202611	6	2016-06-28

US Patents and Regulatory Information for mirabegron

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ascent Pharms Inc	MIRABEGRON	mirabegron	TABLET, EXTENDED RELEASE;ORAL	218172-001	Sep 24, 2025	AB	RX	No	No
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	AB	RX	Yes	Yes					Y
Alkem Labs Ltd	MIRABEGRON	mirabegron	TABLET, EXTENDED RELEASE;ORAL	215948-001	Feb 12, 2024	AB	RX	No	No
Lupin Ltd	MIRABEGRON	mirabegron	TABLET, EXTENDED RELEASE;ORAL	209485-002	Sep 28, 2022	AB	RX	No	No
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	AB	RX	Yes	Yes					Y

Expired US Patents for mirabegron

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012

EU/EMA Drug Approvals for mirabegron

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 mirabegron

Country	Patent Number	Title	Estimated Expiration
Taiwan	201023857
Russian Federation	2011117274
Spain	2760673
Denmark	2216021
China	102170878

Supplementary Protection Certificates for mirabegron

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

Market Dynamics and Financial Trajectory for Mirabegron

Last updated: September 23, 2025

Introduction

Mirabegron, marketed primarily under the brand name Myrbetriq, is a groundbreaking pharmacological agent developed for the treatment of overactive bladder (OAB). As a selective beta-3 adrenergic receptor agonist, mirabegron offers a novel mechanism compared to traditional antimuscarinics, and its market trajectory reflects evolving therapeutic preferences, regulatory landscapes, and competitive pressures. This article examines the current market dynamics and forecasts the financial trajectory of mirabegron, providing stakeholders with insights into its commercial potential and strategic positioning.

Therapeutic Profile and Market Positioning

Introduced in 2012 by Astellas Pharma, mirabegron emerged as an alternative to antimuscarinic agents, targeting OAB symptoms such as urgency, frequency, and incontinence [1]. Its mechanism of action—stimulating beta-3 adrenergic receptors in the detrusor muscle—relaxes bladder smooth muscle without anticholinergic side effects such as dry mouth and cognitive impairment. This safety profile has catalyzed its acceptance among patients intolerant to traditional therapies, expanding its target population.

The drug's unique therapeutic profile positions it as a premium treatment option, often priced higher than generic antimuscarinics. Its efficacy and tolerability have garnered endorsements from clinical guidelines, thereby cementing its role within the OAB therapeutic landscape.

Market Dynamics

Market Penetration and Adoption Trends

Since its launch, mirabegron has achieved steady adoption across global markets. In the United States, it secured FDA approval in 2012, followed by rapid commercialization [2]. By 2021, its market share among prescription medications for OAB increased gradually, reaching approximately 24% of total OAB drug prescriptions [3].

Key factors driving adoption include:

• Safety and Tolerability: Patients with contraindications to antimuscarinics, such as elderly populations or those with cognitive impairment, favor mirabegron due to its minimal anticholinergic burden.
• Differences in formulary access: Payers increasingly favor drugs with better safety profiles and patient adherence potential, benefiting mirabegron’s positioning.
• Expanding indications: Clinical research suggests potential benefits in conditions like neurogenic detrusor overactivity, supporting broader use.

Competitive Landscape

Mirabegron operates in a competitive environment primarily against antimuscarinics like oxybutynin, tolterodine, and solifenacin, which dominate due to lower costs and established efficacy. Generic formulations of these drugs have exerted downward pressure on market prices.

Despite these challenges, mirabegron's growth is bolstered by its differentiators:

• Reduced side effects: Particularly dry mouth and cognitive impairment.
• Combination therapy potential: Emerging evidence suggests efficacy when combined with other OAB treatments.
• Cost-effectiveness: Long-term adherence and improved quality of life translate into economic benefits, influencing prescribing patterns.

Regulatory Considerations and Approvals

Mirabegron’s approval in various regions, including the European Union in 2013 [4], expanded its market reach. Regulatory agencies' endorsement of its safety profile has promoted clinician confidence and facilitated inclusion in treatment algorithms, further fueling market expansion.

Market Challenges

While promising, several challenges hinder market growth:

• Pricing and reimbursement hurdles: High acquisition costs and inconsistent insurance coverage impact patient access.
• Patent expirations: Loss of exclusivity in some markets leads to erosion of revenues due to generic competition.
• Limited awareness: Especially in low-income regions, awareness and education about its benefits lag, limiting adoption.

Financial Trajectory

Revenue Trends

Astellas Pharma reported net sales of approximately $500 million globally for mirabegron in 2021, representing a compound annual growth rate (CAGR) of roughly 8% since its launch [5]. The U.S. market remains the largest contributor, accounting for nearly 60% of global sales.

Revenue growth is projected to continue modestly, driven by:

• Increased prescriptions in mature markets due to clinician familiarity.
• Expansion into emerging markets, leveraging local partnerships.
• Development of new formulations (e.g., extended-release doses) to improve compliance.

Market Forecasts

Industry analysts forecast the global mirabegron market will reach approximately $1.2 billion by 2027, with a CAGR of around 9%, driven by:

• Growing prevalence of OAB: Aging populations in developed countries heighten demand.
• Increasing acceptance among clinicians and patients: Ongoing education campaigns bolster confidence.
• Product pipeline developments: Fixed-dose combinations and novel delivery systems promise enhanced adherence and efficacy.

Emerging markets in Asia-Pacific and Latin America are expected to account for a significant portion of this growth, given increasing healthcare expenditure and population aging.

Impact of Generic Competition

Patent expirations, notably in the U.S. expected in 2026, will introduce generic mirabegron formulations, exerting downward pricing pressure and affecting revenue streams. The transition period necessitates strategic repositioning, such as product line extensions or combination therapies to sustain profitability.

Research & Development Investment

Continued R&D investments aim to expand therapeutic indications and improve formulations. Companies exploring analogous beta-3 receptor agonists or combination agents could redefine the competitive landscape and open new revenue streams.

Market Drivers and Barriers

Drivers

• Demographic shifts: Aging populations globally increase OAB prevalence.
• Preference shift: Patients and clinicians favor drugs with better tolerability profiles.
• Guideline endorsements: Formal recommending of mirabegron supports market expansion.
• Innovation in drug delivery: New formulations enhance adherence.

Barriers

• Pricing pressures and reimbursement constraints reduce profit margins.
• Generic entry may diminish premium pricing.
• Limited awareness in developing regions hampers access.
• Alternative therapies: Emerging treatments could challenge mirabegron’s market share.

Strategic Opportunities

• Combination therapies: Investigating fixed-dose combinations with other OAB agents or antimuscarinics.
• Market expansion: Targeting underpenetrated regions like Southeast Asia and Africa.
• Patient adherence programs: Leveraging digital health tools to improve compliance.
• Biomarker research: Personalizing therapy to enhance efficacy.

Conclusion

Mirabegron’s market trajectory highlights its evolution from a novel option to an established, preferred therapy in specific patient cohorts. While competitive pressures and upcoming patent expirations pose challenges, strategic innovation, market expansion, and clinical advocacy will be vital to sustain its growth. The ongoing integration of mirabegron into comprehensive OAB management contributes to a compound annual growth rate aligning with industry projections—affirming its role in the future of bladder disorder therapeutics.

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Key Takeaways

• Mirabegron’s unique mechanism provides a differentiated position in the OAB market, emphasizing safety and tolerability.
• Its current global revenue approximates $500 million, with forecasts projecting growth to over $1.2 billion by 2027.
• Market expansion hinges on demographic trends, clinician acceptance, and strategic entry into emerging markets.
• Patent expirations and generic competition will challenge profitability, requiring innovation and pipeline diversification.
• Strategic initiatives include combination therapies, targeted marketing, and awareness campaigns to sustain momentum.

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FAQs

1. What distinguishes mirabegron from traditional OAB treatments?
Mirabegron offers a selective beta-3 adrenergic receptor agonist mechanism, reducing common antimuscarinic side effects like dry mouth and cognitive impairment. Its tolerability profile makes it suitable for elderly and sensitive populations.

2. How does the patent landscape impact mirabegron’s market potential?
Patent protections currently sustain premium pricing; however, patent expiration (~2026 in the U.S.) will lead to generic competition, pressuring prices and revenues.

3. What are the primary markets driving mirabegron sales?
The United States remains the largest market, followed by Europe and Japan. Emerging markets in Asia-Pacific and Latin America are expected to offer significant growth opportunities.

4. Are there new formulations or indications for mirabegron?
Research centers on combination therapies and extended-release formulations to improve adherence and efficacy. New indications like neurogenic detrusor overactivity are under clinical investigation.

5. What strategic moves can pharmaceutical companies employ to maximize mirabegron’s market value?
Investing in pipeline innovations, expanding indications, entering new geographic markets, and enhancing patient adherence strategies will be critical for optimizing long-term revenue.

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References

[1] Astellas Pharma. (2012). FDA approval of Myrbetriq.
[2] U.S. Food and Drug Administration. (2012). Mirabegron approval document.
[3] IQVIA. (2021). Market Share Reports for OAB therapeutics.
[4] European Medicines Agency. (2013). Approval of Mirabegron in the EU.
[5] Astellas Pharma. (2022). Annual Report: Financial Review.