Mirabegron - Generic Drug Details

What are the generic drug sources for mirabegron and what is the scope of patent protection?

Mirabegron is the generic ingredient in three branded drugs marketed by Alkem Labs Ltd, Apgdi, Apotex, Ascent Pharms Inc, Lupin Ltd, MSN, Qilu, Sawai Usa, and Zydus Pharms, and is included in twelve 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 are two tentative approvals for this compound.

Summary for mirabegron

International Patents:	66
US Patents:	6
Tradenames:	3
Applicants:	9
NDAs:	12
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	162
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 Naples	PHASE3
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	PHASE4

See all mirabegron clinical trials

Generic filers with tentative approvals for MIRABEGRON

Applicant	Application No.	Strength	Dosage Form
		50MG	TABLET, EXTENDED RELEASE;ORAL
		25MG	TABLET, EXTENDED RELEASE

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
Lupin Ltd	MIRABEGRON	mirabegron	TABLET, EXTENDED RELEASE;ORAL	209485-001	Sep 28, 2022	AB	RX	No	No
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	AB	RX	Yes	Yes	12,097,189*PED				Y
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	AB	RX	Yes	Yes	11,707,451*PED				Y
Apotex	MIRABEGRON	mirabegron	TABLET, EXTENDED RELEASE;ORAL	209434-002	Jan 2, 2025		DISCN	No	No
Ascent Pharms Inc	MIRABEGRON	mirabegron	TABLET, EXTENDED RELEASE;ORAL	218172-002	Sep 24, 2025	AB	RX	No	No

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	6,562,375
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	6,699,503
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	7,750,029
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	6,699,503

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
South Korea	20110071103
European Patent Office	2554168
Slovenia	2216021
Lithuania	2345410
Japan	2018090490	ミラベグロン含有医薬組成物 (MIRABEGRON-CONTAINING PHARMACEUTICAL COMPOSITION)

Supplementary Protection Certificates for mirabegron

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1028111	CA 2013 00029	Denmark		PRODUCT NAME: MIRABEGRON OR SALTS THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
1559427	168 5014-2013	Slovakia		PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: EU/1/12/809/001 - EU/1/12/809/014 20121220
1028111	C300598	Netherlands		PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427	CR 2013 00028	Denmark		PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220
1559427	33/2013	Austria		PRODUCT NAME: MIRABEGRON ODER DESSEN SALZE; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220

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.

---

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.

---

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.

---

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