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 Apgdi, Alkem Labs Ltd, Apotex, Lupin Ltd, Sawai Usa, and Zydus Pharms, and is included in seven 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. Six 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:	6
NDAs:	7
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	143
Patent Applications:	869
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
Seoul National University Hospital	Phase 2
Il-Yang Pharm. Co., Ltd.	Phase 2
Cedars-Sinai Medical Center	Phase 2

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
		50MG	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
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	AB	RX	Yes	Yes	11,707,451*PED				Y
Sawai Usa	MIRABEGRON	mirabegron	TABLET, EXTENDED RELEASE;ORAL	209446-001	Dec 27, 2019		DISCN	No	No
Lupin Ltd	MIRABEGRON	mirabegron	TABLET, EXTENDED RELEASE;ORAL	209485-001	Sep 28, 2022	AB	RX	No	No
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	AB	RX	Yes	Yes	12,097,189
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	12,097,189

Expired US Patents for mirabegron

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

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/002388 Symptomatic 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
Canada	2704298	COMPOSITION PHARMACEUTIQUE POUR TRAITER UNE VESSIE HYPERACTIVE (PHARMACEUTICAL COMPOSITION FOR TREATING OVERACTIVE BLADDER)
Russian Federation	2495666	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ МОДИФИЦИРОВАННОГО ВЫСВОБОЖДЕНИЯ (MODIFIED RELEASE PHARMACEUTICAL COMPOSITION)
Canada	2740342	COMPOSITION PHARMACEUTIQUE A LIBERATION CONTROLEE (PHARMACEUTICAL COMPOSITION FOR MODIFIED RELEASE)
China	102170878	Controlled release pharmaceutical composition
World Intellectual Property Organization (WIPO)	2010038690
Hungary	E046729

Supplementary Protection Certificates for mirabegron

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1028111	C300598	Netherlands		PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION 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
1559427	300599	Netherlands		PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20130107
1559427	122013000047	Germany		PRODUCT NAME: MIRABEGRON ODER EIN SALZ DAVON; NAT. REGISTRATION NO/DATE: EU /1/12/809/001-014 20121220; FIRST REGISTRATION: EU 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	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 for Mirabegron

Introduction to Mirabegron

Mirabegron, a β-3 adrenergic receptor agonist, has emerged as a significant player in the treatment of overactive bladder (OAB). Approved by the FDA in 2012, it has quickly gained traction due to its efficacy and favorable safety profile.

Market Share and Dominance

Mirabegron holds a substantial market share in the OAB treatment market. As of 2023, it accounted for approximately 27.6% to 28% of the market share, making it the leading drug in its category[1][3][4].

Therapeutic Benefits

Mirabegron is administered as an extended-release oral tablet and is effective in managing symptoms of OAB, including urge urinary incontinence, urgency, and frequent urination. Its mechanism involves inducing detrusor smooth muscle relaxation during the storage phase, thereby increasing bladder capacity[5].

Safety Profile

One of the key factors contributing to mirabegron's popularity is its safety profile. Studies have shown that mirabegron has a low incidence of adverse events (AEs) compared to antimuscarinics, which are traditionally used to treat OAB. The adverse effects of mirabegron are generally mild and well-tolerated, making it a safe and effective treatment option[1][3][5].

Regulatory Approvals and Expansion

The increasing regulatory approvals for mirabegron are a significant driver of its market growth. As more regions and healthcare systems approve its use, the demand for mirabegron is expected to rise. This widespread acceptance is further bolstered by its inclusion in various treatment guidelines and recommendations[1][3].

Economic Impact

The economic impact of mirabegron on healthcare systems is multifaceted. While the prescription costs of mirabegron are higher than those of generic antimuscarinics, the overall medical costs can be offset by the reduction in health resource utilization (HRU) and the management of comorbidities such as urinary tract infections (UTIs), skin rashes, and depression.

• Budget Impact Analysis: Studies have shown that for a 1 million-member U.S. commercial payer plan, the total prescription costs increase, but the total medical costs decrease over a 3-year period. The incremental costs are less than 2% of the current OAB treatment costs. For Medicare Advantage plans, the incremental costs are less than 4%[2].

• Cost Savings: Mirabegron addresses an unmet need for patients who are intolerant to anticholinergic adverse effects or at risk of cognitive impairment. The moderate additional economic cost of using mirabegron can be offset by the medical cost savings, making it a viable option for healthcare plans[2].

Market Growth and Projections

The global overactive bladder treatment market, which includes mirabegron, is projected to grow significantly. Here are some key projections:

• Market Size: The global OAB treatment market was estimated at around USD 4.01 billion in 2023 and is projected to reach USD 6.43 billion by 2033, growing at a CAGR of 4.85% from 2024 to 2033[3].

• Regional Dominance: North America leads the market with a significant share of 37% in 2023, driven by the strong presence of key industry players such as Pfizer, Inc., AbbVie, Inc., and Viatris, Inc.[3].

• Sales Projections: Global sales for OAB treatments, with mirabegron being a major contributor, are expected to increase from $2.2 billion in 2020 to $2.8 billion in 2030 at a CAGR of 2.7%[4].

Competitive Landscape

Mirabegron competes in a market segmented into anticholinergics, mirabegron, Botox, neuromodulation, and other categories. While antimuscarinics are highly genericized and widely used, mirabegron's unique mechanism of action and favorable safety profile set it apart.

• Key Players: Companies like Pfizer, Inc., AbbVie, Inc., and Viatris, Inc. are significant players in the OAB treatment market. Viatris Inc., for example, is developing Onabotulinumtoxin A (Botox) for OAB and cervical dystonia, expected to be launched by 2026[3].

Future Outlook

The future outlook for mirabegron is promising, driven by several factors:

• Increasing Prevalence of OAB: The growing prevalence of OAB and the need for effective treatment options will continue to drive the demand for mirabegron.

• Clinical Trials and Product Pipelines: Ongoing clinical trials and the expansion of product pipelines by key industry players will further enhance the market position of mirabegron.

• Regulatory Environment: Continued regulatory approvals and recommendations will support the widespread adoption of mirabegron.

Key Takeaways

• Market Dominance: Mirabegron holds a significant market share in the OAB treatment market.
• Therapeutic Benefits: It is effective in managing OAB symptoms with a favorable safety profile.
• Economic Impact: While it incurs higher prescription costs, it can reduce overall medical costs.
• Market Growth: The global OAB treatment market is projected to grow at a CAGR of 4.85% from 2024 to 2033.
• Competitive Landscape: Mirabegron competes effectively against traditional antimuscarinics and other treatments.

FAQs

Q: What is mirabegron and how does it work? A: Mirabegron is a β-3 adrenergic receptor agonist that induces detrusor smooth muscle relaxation during the storage phase, increasing bladder capacity and managing symptoms of overactive bladder.

Q: What is the market share of mirabegron in the OAB treatment market? A: As of 2023, mirabegron held approximately 27.6% to 28% of the market share in the OAB treatment market.

Q: How does the safety profile of mirabegron compare to other OAB treatments? A: Mirabegron has a low incidence of adverse events and is generally well-tolerated, making it a safer option compared to traditional antimuscarinics.

Q: What is the projected growth of the global OAB treatment market? A: The global OAB treatment market is projected to grow from USD 4.01 billion in 2023 to USD 6.43 billion by 2033 at a CAGR of 4.85%.

Q: How does the economic impact of mirabegron affect healthcare systems? A: While mirabegron incurs higher prescription costs, it can reduce overall medical costs by decreasing health resource utilization and managing comorbidities.

Sources

1. Grand View Research - Overactive Bladder Treatment Market Size Report, 2030
2. PubMed - Estimated Budget Impact of Increased Use of Mirabegron, A Novel ...
3. Vision Research Reports - Overactive Bladder Treatment Market Size, Growth, Trends, Report ...
4. Business Wire - Global Overactive Bladder Drug Forecast and Market Analysis ...
5. Frontiers in Pharmacology - Examining the safety of mirabegron: an analysis of real-world ...

Last updated: 2024-12-17