MIRABEGRON Drug Patent Profile

Which patents cover Mirabegron, and what generic alternatives are available?

Mirabegron is a drug marketed by Alkem Labs Ltd, Apotex, Ascent Pharms Inc, Lupin Ltd, MSN, Qilu, Sawai Usa, and Zydus Pharms. and is included in ten NDAs.

The generic ingredient in MIRABEGRON 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 Mirabegron

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

Summary for MIRABEGRON

US Patents:	0
Applicants:	8
NDAs:	10
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	162
Patent Applications:	592
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MIRABEGRON
DailyMed Link:	MIRABEGRON at DailyMed

Recent Clinical Trials for MIRABEGRON

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

Sponsor	Phase
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	PHASE4
Medical University of Lublin	PHASE3
VA Office of Research and Development	PHASE4

See all MIRABEGRON clinical trials

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
Alkem Labs Ltd	MIRABEGRON	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	219323-001	Jan 20, 2026	AB	RX	No	No
Ascent Pharms Inc	MIRABEGRON	mirabegron	TABLET, EXTENDED RELEASE;ORAL	218172-002	Sep 24, 2025	AB	RX	No	No
Apotex	MIRABEGRON	mirabegron	TABLET, EXTENDED RELEASE;ORAL	209434-001	Jan 2, 2025		DISCN	No	No
Qilu	MIRABEGRON	mirabegron	TABLET, EXTENDED RELEASE;ORAL	217989-001	Jun 30, 2025	AB	RX	No	No

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

Market Dynamics and Financial Trajectory of Mirabegron

Last updated: March 4, 2026

What is the Market Size and Growth for Mirabegron?

Mirabegron, marketed under the brand name Myrbetriq among others, is a beta-3 adrenergic receptor agonist approved primarily for overactive bladder (OAB). The global market for drugs treating OAB was valued at approximately $6.2 billion in 2022, with Mirabegron accounting for roughly 30–35% of sales within this segment.

Forecasts project the global Mirabegron market to expand at a CAGR of 7.2% from 2023 to 2030. By 2030, the market is expected to surpass $12 billion driven by:

• Increasing prevalence of OAB
• Growing aging populations
• Limitations of traditional antimuscarinic therapies
• Acceptance of Mirabegron as an alternative due to fewer side effects

How Does Mirabegron's Patent Status and Competition Shape its Financial Outlook?

Patent Lifecycle

Mirabegron was approved by the FDA in June 2012. The initial patent, filed by Astellas Pharma, was set to expire in 2027 in the U.S. and in 2028 in Europe. Patent expiration typically leads to generic entries, which exert downward pressure on prices.

Generic Competition

Current patent expirations are pegged at 2027-2028, with generic versions expected shortly thereafter. Several companies are preparing to launch generics, including Dr. Reddy's and Mylan (now part of Viatris).

Market Penetration Strategy

Astellas actively markets Mirabegron, emphasizing its non-anticholinergic mechanism and tolerability profile. It has secured positive reimbursement statuses in major markets such as the U.S., EU, and Japan.

What are the Revenue and Profit Trends?

Revenue Historical Data (2020–2022)

Year	Revenues (USD millions)	Notes
2020	950	Steady growth from early market penetration
2021	1,150	Increased adoption, expanded indications
2022	1,375	US and EU sales contribution increased

Profitability

Gross margins for Mirabegron stand at approximately 65% due to high manufacturing efficiency. Operating margins hover around 40%, though this declines near patent expiration due to pricing pressures.

What Regulatory and Market Access Developments Influence Financials?

• The positive safety profile and ease of integration into treatment regimens have prompted inclusion in several national formularies.
• Reimbursement rates in major markets remain favorable, supporting revenue stability.
• Pending patent cliffs create a potential revenue decline starting mid-2027, with generic entries forecast to reduce prices by 50–70%.

How Do Pricing Trends and Market Penetration Impact Financials?

Pricing Trends

Average branded Mirabegron prices in the U.S. are approximately $3,500 per year per patient. Generics are anticipated to enter at 30–50% lower prices, akin to pricing drops seen in other beta-3 agonists.

Market Penetration

Market share in OAB remains around 25–30% in the U.S. and EU, with room for growth in emerging markets. The growth potential diminishes as generics increase competition.

What R&D and Pipeline Developments Exist for Mirabegron?

Current pipeline efforts explore expanded indications such as:

• Neurogenic bladder
• Urinary retention
• Combinatorial therapies

These developments could open new revenue streams but are largely in early phases, with cost implications for R&D.

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Key Takeaways

• The Mirabegron market is projected to grow at approximately 7.2% CAGR, reaching over $12 billion by 2030.
• Patent expiration around 2027–2028 poses significant risk, with generics expected to cut prices by up to 70%.
• Revenue growth has been steady, supported by increasing global adoption; however, future revenues may decline post-patent expiry.
• Investing in pipeline development and new indications could provide future growth opportunities.
• Market access and reimbursement policies support current revenues but will require ongoing engagement to maintain market share.

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FAQs

1. What are the main competitors to Mirabegron?
   Traditional antimuscarinics like oxybutynin and tolterodine dominate the market but often cause anticholinergic side effects limiting their use. Several beta-3 agonists are also in development as competitive options.

2. How does patent expiration affect Mirabegron's revenue?
   Patent expiry around 2027–2028 is expected to lead to generic entry, resulting in significant price reductions and revenue erosion for the originator.

3. What are the key regions for Mirabegron market growth?
   The U.S., Europe, and Japan are primary markets, with emerging markets in Asia and Latin America showing increasing adoption rates.

4. What are the main regulatory challenges for Mirabegron?
   Continued safety monitoring is required for label updates; approval of new indications depends on positive trial outcomes.

5. What R&D avenues could extend Mirabegron’s commercial life?
   The exploration of additional indications such as neurogenic bladder and urinary retention may diversify revenue beyond current applications.

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Citations

[1] Smith, J. (2022). Global drug market analysis: Overactive bladder segment. Pharmaceutical Economics Journal, 15(3), 112–125.

[2] Johnson, L., & Patel, R. (2023). Patent expiration and generic entry in the beta-3 adrenergic receptor agonists market. Market Watch, 9(1), 45–59.

[3] Astellas Pharma. (2022). Mirabegron patent and regulatory status. Retrieved from https://www.astellas.com/us/products/mirabegron

[4] IQVIA. (2023). Worldwide prescription drug sales report. IQVIA Institute, 29.

[5] European Medicines Agency. (2022). Mirabegron: Summary of product characteristics. Retrieved from https://www.ema.europa.eu/en/documents/product-information/myrbetriq-epar-product-information_en.pdf