MYRBETRIQ Drug Patent Profile

Which patents cover Myrbetriq, and when can generic versions of Myrbetriq launch?

Myrbetriq is a drug marketed by Apgdi and is included in two NDAs. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in twenty-five countries.

The generic ingredient in MYRBETRIQ 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

A generic version of MYRBETRIQ was approved as mirabegron by LUPIN LTD on September 28^th, 2022.

Summary for MYRBETRIQ

International Patents:	53
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	52
Patent Applications:	592
Drug Prices:	Drug price information for MYRBETRIQ
Drug Sales Revenues:	Drug sales revenues for MYRBETRIQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYRBETRIQ
What excipients (inactive ingredients) are in MYRBETRIQ?	MYRBETRIQ excipients list
DailyMed Link:	MYRBETRIQ at DailyMed

See drug prices for MYRBETRIQ

See drug sales revenues for MYRBETRIQ

Recent Clinical Trials for MYRBETRIQ

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

Sponsor	Phase
Seoul National University Hospital	Phase 2
Il-Yang Pharm. Co., Ltd.	Phase 2
Cedars-Sinai Medical Center	Phase 2

See all MYRBETRIQ clinical trials

Pharmacology for MYRBETRIQ

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYRBETRIQ	Extended-release Tablets	mirabegron	50 mg	202611	6	2016-06-28

US Patents and Regulatory Information for MYRBETRIQ

MYRBETRIQ is protected by five 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	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	AB	RX	Yes	Yes	8,772,315*PED				Y
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	AB	RX	Yes	Yes	11,707,451*PED				Y
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	AB	RX	Yes	Yes	10,842,780*PED				Y

Expired US Patents for MYRBETRIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	6,699,503
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	6,562,375
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	7,750,029

EU/EMA Drug Approvals for MYRBETRIQ

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

When does loss-of-exclusivity occur for MYRBETRIQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Croatia

Cyprus

Denmark

European Patent Office

Japan

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MYRBETRIQ around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2262528
Canada	2305802	DERIVES AMIDES OU SELS DESDITS DERIVES (AMIDE DERIVATIVES OR SALTS THEREOF)
Germany	60336334

Supplementary Protection Certificates for MYRBETRIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1559427	C20130015 00094	Estonia		PRODUCT NAME: MIRABEGROON;REG NO/DATE: K(2012)9945 (LOPLIK) 20.12.2012
1559427	CA 2013 00028	Denmark
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 of MYRBETRIQ

Last updated: November 7, 2025

Introduction

MYRBETRIQ (mirabegron), developed and marketed by Astellas Pharma Inc., is a novel oral therapy approved for the treatment of overactive bladder (OAB). As a selective beta-3 adrenergic receptor agonist, MYRBETRIQ garnered regulatory approval in various markets starting in 2018, positioning itself as an alternative to antimuscarinic agents. Understanding the evolving market landscape and financial outlook for MYRBETRIQ informs stakeholders—pharmaceutical companies, investors, and healthcare providers—about its growth prospects and strategic challenges.

Market Landscape and Key Drivers

Prevalence and Demographics

The global prevalence of overactive bladder is estimated at 12–20%, affecting approximately 200 million individuals worldwide.[1] An aging global population amplifies demand, as OAB incidence escalates with age. Given the shift towards less invasive, better-tolerated therapies, MYRBETRIQ's profile aligns with current market needs.

Regulatory Approvals and Geographic Expansion

MYRBETRIQ received FDA approval in 2018 for the treatment of OAB in adults, followed by approvals from the European Medicines Agency (EMA) and other regulatory agencies. Its launch in the U.S. and Europe marked a significant milestone, with subsequent rollouts expanding into Asian markets such as Japan and South Korea.[2]

Competitive Landscape

The OAB market primarily competes among antimuscaractic agents—such as oxybutynin, tolterodine, and solifenacin—and other beta-3 adrenergic receptor agonists like Urgency by urovant Sciences (initially licensed to Allergan). MYRBETRIQ differentiates through its tolerability profile; it exhibits fewer anticholinergic side effects like dry mouth and cognitive impairment, common barriers to adherence.

Market Penetration and Adoption Factors

Early adoption driven by urologists and primary care physicians hinges on evidence-based efficacy, safety profile, formulary placement, and patient preferences. The medication’s once-daily dosing enhances adherence, supporting its acceptance. However, barriers include high medication costs, insurance coverage variability, and competition from established therapies.

Financial Trajectory and Revenue Outlook

Initial Commercial Performance

In its first fiscal years (2018–2020), MYRBETRIQ’s sales growth was modest, constrained by limited market penetration and generic competition. The initial launch faced hurdles from formulary restrictions and the need for physician education on its benefits. Nonetheless, global sales increased steadily, with North America and Europe serving as primary markets.[3]

Revenue Growth Drivers

• Market Expansion: Introduction into additional territories, including Asian markets with aging demographics, broadens revenue streams.
• Payer Dynamics: Enhanced formulary coverage and reduced copayments improve patient access.
• Clinical Data and Real-World Evidence: Growing evidence of superior tolerability supports prescriber confidence, thereby driving sales.

Challenges Impacting Financial Trajectory

• Pricing Pressures: Rising drug affordability concerns lead to downward pressure on prices, especially in markets emphasizing cost-effectiveness.
• Generic Competition: The imminent availability of generic mirabegron post-patent expiry (expected around 2028) could significantly erode revenues.
• Market Saturation: Existing treatment levels, especially among patients inadequately managed with first-line therapies, moderate growth potential.

Forecast and Strategic Outlook

Industry analysts project that MYRBETRIQ’s global sales could reach approximately $1.2 billion by 2025, representing a compound annual growth rate (CAGR) of around 8–10% from 2021 levels.[4] Market penetration strategies, such as expanding into urology clinics and geriatric care, play a vital role.

Astellas’ continued investments in clinical trials evaluating MYRBETRIQ in other indications (e.g., neurogenic bladder, urge incontinence) may unlock additional revenue pathways, further influencing its financial trajectory.

Market Risks and Opportunities

Risks

• Generic Entry: Patent expiry and generic competition pose substantial revenue risks.
• Regulatory Changes: Evolving reimbursement policies could hamper access and profitability.
• Market Penetration Challenges: Slow uptake in certain markets due to entrenched prescribing patterns.

Opportunities

• Combination Therapies: Potential development of combination regimens to improve efficacy.
• Broadening Indications: Expanding indications beyond OAB could open new revenue streams.
• Market Diversification: penetrating emerging markets with growing healthcare infrastructure offers significant upside.

Conclusion

MYRBETRIQ's market dynamics are shaped by demographic trends, clinical positioning, competitive forces, and macroeconomic factors such as healthcare policies. Its financial trajectory appears promising in the medium term, driven by demographic aging, enhanced awareness, and expanding clinical evidence. However, looming patent cliffs and intensifying competition necessitate strategic adaptations to sustain growth.

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Key Takeaways

• MYRBETRIQ positions itself as a tolerable, effective alternative to traditional antimuscarinics, anchoring its growth in the expanding global OAB market.
• Geographic expansion, especially into high-growth Asian markets, significantly influences its revenue trajectory.
• Pricing pressures and imminent patent expiry underscore the importance of lifecycle management and diversification strategies.
• Continuous clinical research and expanded indications could unlock further market opportunities.
• Stakeholders should monitor regulatory developments, reimbursement trends, and competitive dynamics to anticipate future market shifts.

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FAQs

Q1: What is the current patent status of MYRBETRIQ, and when is generic entry expected?
A: The patent for mirabegron in developed markets is expected to expire around 2028. Following patent expiration, generic versions are anticipated to enter the market, potentially reducing pricing and revenue for the originator.

Q2: How does MYRBETRIQ differentiate itself from other OAB treatments?
A: MYRBETRIQ offers a selective beta-3 adrenergic receptor agonist mechanism with fewer anticholinergic side effects like dry mouth and cognitive impairment, improving patient adherence.

Q3: What are the main barriers to MYRBETRIQ adoption?
A: Barriers include high medication costs, reimbursement complexities, limited awareness among physicians, and competition from well-established antimuscarinics.

Q4: Are there ongoing clinical trials expanding MYRBETRIQ’s indications?
A: Yes, ongoing studies are evaluating its efficacy in neurogenic bladder, urine incontinence, and other urological conditions, which could broaden its market application.

Q5: What strategic initiatives can Astellas undertake to sustain MYRBETRIQ’s growth?
A: Astellas can focus on geographic expansion, clinical research for new indications, forming strategic partnerships, and engaging in lifecycle management through formulations and delivery innovations.

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References:

[1] M. M. FitzGerald et al., “Overactive Bladder: Global Prevalence, Burden and Treatment,” Clinical Medicine Insights: Urology, 2020.
[2] Astellas Pharma Inc., “MYRBETRIQ (mirabegron) Product Information,” 2022.
[3] IQVIA, “Pharmaceutical Market Reports,” 2022.
[4] GlobalData, “Pharma Insight: Overactive Bladder Market Forecast,” March 2023.