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:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	52
Patent Applications:	519
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
Il-Yang Pharm. Co., Ltd.	Phase 2
Seoul National University Hospital	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					Y
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	AB	RX	Yes	Yes					Y
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	AB	RX	Yes	Yes					Y
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	AB	RX	Yes	Yes					Y
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	AB	RX	Yes	Yes					Y
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	AB	RX	Yes	Yes					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
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	202611-002	Jun 28, 2012
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012

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
Portugal	1205190
European Patent Office	2298752	Forme crystalline alpha ou beta d'un derivé d'acetanilide (Alpha-form or beta-form crystal of acetanilide derivative)
Austria	266639
Poland	329233
Brazil	0213570
Norway	334948

Supplementary Protection Certificates for MYRBETRIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1559427	2013/026	Ireland		PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427	C 2013 020	Romania		PRODUCT NAME: MIRABEGRON SAU O SARE A ACESTUIA(2-(2-AMINO-1,3-TRIAZOL-4-IL)-N-[4-(2-{[(2R)-2-HIDROXI9/014; DATE OF NATIONAL AUTHORISATION: 20121220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/809/001 - EU/1/12/809/014; DATE OF FIRST AUTHORISATION IN EEA: 20121220 -2-FENILETIL]AMINO}ETIL)FENIL]ACETAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/12/809/001 - EU/1/12/80
1559427	C20130015 00094	Estonia		PRODUCT NAME: MIRABEGROON;REG NO/DATE: K(2012)9945 (LOPLIK) 20.12.2012
1559427	168 5014-2013	Slovakia		PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: EU/1/12/809/001 - EU/1/12/809/014 20121220
1559427	1390028-7	Sweden		PRODUCT NAME: MIRABEGRON ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/12/809/001 20121220
1028111	300598	Netherlands		PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220

MYRBETRIQ: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

MYRBETRIQ (mirabegron) is a beta-3 adrenergic agonist approved for the treatment of overactive bladder (OAB) with or without urinary urge incontinence, urgency, and frequency. Its market performance is shaped by patent exclusivity, competitive landscape, and evolving therapeutic guidelines.

What is MYRBETRIQ's Market Exclusivity Status?

MYRBETRIQ's primary U.S. patents have expired, impacting its pricing and competitive positioning. The compound patent expired in 2017, and secondary patents related to polymorphs and manufacturing processes also faced expiration in subsequent years.

• Compound Patent Expiration: August 2017.
• Key Secondary Patent Expirations: Several patents related to specific crystal forms and manufacturing methods expired between 2020 and 2023.

The expiration of these patents has opened the door for generic competition, leading to price erosion and a shift in market share. This is a common trajectory for branded pharmaceuticals following patent cliffs.

Who are MYRBETRIQ's Primary Competitors?

MYRBETRIQ competes with other pharmacological agents used to manage OAB, primarily anticholinergics. The competitive landscape is characterized by therapeutic efficacy, side effect profiles, and patient tolerability.

• Anticholinergic Drugs: These represent the historical first-line therapy for OAB and include:

  • Oxybutynin (e.g., Ditropan XL)
  • Tolterodine (e.g., Detrol LA)
  • Solifenacin (e.g., VESIcare)
  • Darifenacin (e.g., Enablex)
  • Fesoterodine (e.g., Toviaz)

• Other Beta-3 Agonists: Vibegron (Vibegron) is a newer beta-3 agonist approved for OAB, directly competing with MYRBETRIQ. Its clinical profile and market penetration are important factors in MYRBETRIQ's market dynamics.

The established use and physician familiarity with anticholinergics, coupled with the emergence of newer agents like vibegron, create a dynamic competitive environment for MYRBETRIQ.

What is MYRBETRIQ's Revenue Performance?

MYRBETRIQ's revenue trajectory has been influenced by its patent status, market penetration, and the increasing presence of generics. Financial reporting from its manufacturer, Astellas Pharma, provides insights into its sales performance.

• Peak Sales: MYRBETRIQ achieved significant sales in the years following its launch and prior to widespread generic entry. For example, in the fiscal year ending March 31, 2021, Astellas reported net sales of MYRBETRIQ (including Mirabegron/Solifenacin combination product) of ¥191.9 billion (approximately $1.77 billion USD at the time) [1].
• Post-Patent Expiration Trends: Following patent expirations and the introduction of generic mirabegron in the U.S. market in late 2021/early 2022, MYRBETRIQ's U.S. sales have experienced a decline. Global sales figures reflect this trend, with a notable decrease in revenue attributed to generic competition. For the fiscal year ending March 31, 2023, Astellas reported global sales for MYRBETRIQ of ¥136.9 billion (approximately $1.01 billion USD at the time) [2], indicating a substantial revenue decrease from its peak. This decline is a direct consequence of market dynamics following patent expiration.

The financial trajectory clearly demonstrates the impact of generic erosion on a branded pharmaceutical's revenue.

How have Clinical Guidelines Affected MYRBETRIQ's Use?

Clinical guidelines for OAB treatment influence prescribing patterns and, consequently, MYRBETRIQ's market position. Guidelines often evolve based on new evidence regarding efficacy, safety, and cost-effectiveness.

• Evolving OAB Treatment Paradigms: Historically, anticholinergics were considered first-line. However, concerns regarding side effects (e.g., dry mouth, constipation, cognitive impairment) led to a re-evaluation of treatment algorithms.
• Guideline Recommendations: Guidelines from organizations such as the American Urological Association (AUA) and the European Association of Urology (EAU) have increasingly recognized the role of beta-3 agonists like MYRBETRIQ as an alternative to anticholinergics, particularly for patients who do not tolerate or respond to anticholinergic therapy. This was a significant driver for MYRBETRIQ's initial market adoption.
• Impact of Newer Agents: The introduction of vibegron has also influenced guideline recommendations, creating a more complex decision-making process for clinicians. Guidelines now often present options for both beta-3 agonists, requiring differentiation based on clinical trial data and physician preference.

The dynamic nature of clinical guidelines, balancing efficacy, tolerability, and cost, continues to shape the therapeutic landscape for OAB.

What is the Outlook for Generic Mirabegron?

The market for generic mirabegron is expected to grow as more patients and payers seek cost-effective alternatives to branded MYRBETRIQ. This segment is driven by price competition and market access.

• Key Generic Entrants: Several pharmaceutical companies have launched generic versions of mirabegron in major markets, including the United States. This has intensified price competition.
• Pricing Pressure: Generic manufacturers typically price their products at a significant discount to the branded equivalent, leading to rapid price erosion for MYRBETRIQ.
• Market Share Shift: The availability of generics leads to a predictable shift in market share from the branded product to the generic versions, particularly in formularies with preferred generic policies.

The growth of the generic mirabegron market directly correlates with the decline in MYRBETRIQ's market share and revenue.

What are the Key Considerations for Investors and R&D?

For investors and R&D professionals, MYRBETRIQ's market trajectory highlights critical factors in pharmaceutical product lifecycle management and market entry strategies.

• Patent Cliff Impact: The decline in MYRBETRIQ's revenue post-patent expiration serves as a case study for the financial implications of patent cliffs.
• Competition Analysis: The competitive environment, including both established therapies and emerging novel agents, necessitates a thorough understanding of differentiation strategies.
• Lifecycle Management: Companies must consider strategies for lifecycle management, such as combination products or new formulations, to extend market exclusivity and revenue generation, although the effectiveness of such strategies diminishes with significant patent expiry.
• R&D Focus: Future R&D in the OAB space may focus on addressing unmet needs, such as treatments with improved efficacy for refractory cases or those with a more favorable side effect profile, potentially leveraging different pharmacological targets or novel drug delivery systems.

Understanding these dynamics is crucial for assessing the long-term viability of existing products and identifying opportunities for future innovation.

Key Takeaways

MYRBETRIQ's market trajectory is characterized by its initial success as a novel OAB treatment, followed by a predictable decline in revenue and market share due to patent expirations and the subsequent entry of generic mirabegron. The competitive landscape includes established anticholinergics and newer beta-3 agonists, with clinical guidelines playing a significant role in shaping prescribing patterns. The financial performance of MYRBETRIQ serves as a clear example of the impact of patent cliffs on branded pharmaceuticals.

FAQs

1. When did MYRBETRIQ first receive FDA approval? MYRBETRIQ (mirabegron) received its initial U.S. Food and Drug Administration (FDA) approval on June 28, 2011 [3].

2. What is the typical dosage of MYRBETRIQ? MYRBETRIQ is typically available in extended-release formulations with dosages of 25 mg and 50 mg. The starting dose is usually 25 mg once daily, which can be increased to 50 mg once daily based on individual patient response and tolerability [4].

3. Are there any contraindications for MYRBETRIQ? MYRBETRIQ is contraindicated in patients with known hypersensitivity to mirabegron. It is also cautioned for use in patients with uncontrolled hypertension, as it can elevate blood pressure. Patients with severe urinary retention or gastric retention also represent contraindications [4].

4. What is the mechanism of action of MYRBETRIQ? MYRBETRIQ is a selective agonist of the beta-3 adrenergic receptor. By activating these receptors in the detrusor muscle of the bladder, it promotes bladder relaxation, leading to increased bladder capacity and a reduction in urinary urgency, frequency, and incontinence episodes [4].

5. What was the primary reason for MYRBETRIQ's revenue decline after its peak sales? The primary reason for MYRBETRIQ's revenue decline after its peak sales was the expiration of its key U.S. patents. This expiration allowed generic pharmaceutical companies to enter the market with lower-cost versions of mirabegron, leading to significant price erosion and a shift in market share away from the branded product [1, 2].

Citations

[1] Astellas Pharma Inc. (2021). Consolidated Financial Results for the Fiscal Year Ended March 31, 2021. Retrieved from https://www.astellas.com/en/investors/financial-results (Note: Specific press release URL may vary year to year, general investor relations page provided.)

[2] Astellas Pharma Inc. (2023). Consolidated Financial Results for the Fiscal Year Ended March 31, 2023. Retrieved from https://www.astellas.com/en/investors/financial-results (Note: Specific press release URL may vary year to year, general investor relations page provided.)

[3] U.S. Food and Drug Administration. (2011, June 28). FDA approves new treatment for overactive bladder. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-overactive-bladder

[4] MYRBETRIQ [mirabegron] prescribing information. (2023). Astellas Pharma US, Inc. Retrieved from https://www.astellas.com/us/products/myrbetriq (Note: Specific prescribing information PDF link may change.)