MYRBETRIQ GRANULES Drug Patent Profile

When do Myrbetriq Granules patents expire, and what generic alternatives are available?

Myrbetriq Granules is a drug marketed by Apgdi and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in thirteen countries.

The generic ingredient in MYRBETRIQ GRANULES is mirabegron. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the mirabegron profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Myrbetriq Granules

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

Summary for MYRBETRIQ GRANULES

International Patents:	13
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Patent Applications:	220
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYRBETRIQ GRANULES
DailyMed Link:	MYRBETRIQ GRANULES at DailyMed

Pharmacology for MYRBETRIQ GRANULES

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 GRANULES

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYRBETRIQ GRANULES	Granules for Extended-release Suspension	mirabegron	8 mg/mL	213801	1	2024-01-12

US Patents and Regulatory Information for MYRBETRIQ GRANULES

MYRBETRIQ GRANULES is protected by one 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 GRANULES	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	213801-001	Mar 25, 2021		RX	Yes	Yes	10,058,536*PED				Y

EU/EMA Drug Approvals for MYRBETRIQ GRANULES

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 MYRBETRIQ GRANULES

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2298752	Forme crystalline alpha ou beta d'un derivé d'acetanilide (Alpha-form or beta-form crystal of acetanilide derivative)
China	1243740
Spain	2404071
Croatia	P20192213
Russian Federation	2004116313
Brazil	0213570

Supplementary Protection Certificates for MYRBETRIQ GRANULES

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	92218	Luxembourg		PRODUCT NAME: MIRABEGRON OU UN DE SES SELS
1559427	C01559427/01	Switzerland		PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: SWISSMEDIC 62755 19.05.2014
1559427	132013902166933	Italy		PRODUCT NAME: MIRABEGRON(BETMIGA); AUTHORISATION NUMBER(S) AND DATE(S): 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	SPC/GB13/035	United Kingdom		PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTERED: UK EU/1/12/809/001-014 20130107

Market Dynamics and Financial Trajectory for Myrbetriq Granules

Introduction

Myrbetriq Granules, developed by Astellas Pharma Inc., is a significant advancement in the treatment of neurogenic detrusor overactivity (NDO) and overactive bladder (OAB) symptoms. This article delves into the market dynamics and financial trajectory of Myrbetriq Granules, highlighting its impact, market share, and future prospects.

FDA Approval and Market Impact

In March 2021, the U.S. FDA approved Myrbetriq Granules (mirabegron for extended-release oral suspension) for the treatment of NDO in pediatric patients aged three years and older. This approval marked a significant milestone, as it introduced a new treatment option for a previously underserved patient population. Myrbetriq Granules are particularly beneficial for children who have difficulty swallowing tablets, making it a more accessible treatment[1].

Market Share and Dominance

Myrbetriq, including both the tablet and granule forms, holds a substantial market share in the overactive bladder treatment market. As of 2023, mirabegron, the active ingredient in Myrbetriq, accounted for 27.6% of the market share, making it the leading drug in its category. This dominance is attributed to its efficacy in treating symptoms of urge urinary incontinence, urgency, and frequent urination, along with its favorable safety profile[3].

Competitive Landscape

The overactive bladder treatment market is segmented into various types, including anticholinergics, mirabegron, Botox, neuromodulation, and others. Myrbetriq Granules compete primarily with anticholinergics, but its fewer side effects and ease of administration give it a competitive edge. The market is also seeing growth in other segments, such as neuromodulation and Botox, but mirabegron remains a leader due to its widespread acceptance and regulatory approvals[5].

Financial Performance

The approval of Myrbetriq Granules for NDO in children has positively impacted Astellas Pharma's financial forecast. The company reflected the impact of this FDA approval in its financial forecast for the fiscal year ending March 31, 2021. The sales of Myrbetriq, including both tablet and granule forms, have contributed significantly to Astellas' revenue. For instance, the overall OAB treatments, which include Myrbetriq, have shown steady growth on a constant currency basis[2].

Regional Market Performance

The overactive bladder treatment market is geographically diverse, with North America dominating the market with a 36.5% share in 2023. The presence of key industry players such as Pfizer, AbbVie, and Viatris in this region contributes to its high revenue share. Myrbetriq Granules, being part of this market, benefit from the strong healthcare infrastructure and favorable reimbursement policies in North America[3].

Growth Drivers

Several factors drive the growth of Myrbetriq Granules in the market:

• Regulatory Approvals: The FDA approval for NDO in children has expanded the patient population, contributing to increased sales.
• Efficacy and Safety: Mirabegron's mild and tolerable side effects make it a preferred choice among healthcare providers and patients.
• Ease of Administration: The granule form is particularly beneficial for pediatric patients who may have difficulty swallowing tablets.
• Market Demand: The rising prevalence of overactive bladder syndrome and favorable reimbursement policies further boost the demand for Myrbetriq Granules[3][5].

Future Prospects

The overactive bladder treatment market is expected to grow from USD 3.5 billion in 2022 to USD 4.2 billion by 2027. Myrbetriq Granules are poised to continue their market dominance due to ongoing clinical trials and the expansion of treatment indications. The Asia Pacific region, in particular, is expected to see significant growth, with mirabegron accounting for a large share of the market in this region[5].

Pipeline and Development

Astellas Pharma continues to invest in research and development, ensuring that Myrbetriq remains at the forefront of bladder treatment options. The company's strategic plan includes maximizing product value, creating innovation, and pursuing operational excellence, which will likely lead to further approvals and indications for Myrbetriq Granules[2].

Distribution and Accessibility

The availability of Myrbetriq Granules through various distribution channels, including e-commerce platforms, enhances their accessibility. This convenience, combined with the advantages of online shopping such as time-saving and discounts, is expected to boost the segment growth over the forecast period[3].

Conclusion

Myrbetriq Granules have established themselves as a critical treatment option for NDO and OAB, particularly in pediatric patients. With a strong market share, favorable regulatory environment, and ongoing clinical developments, Myrbetriq Granules are set to continue their dominance in the overactive bladder treatment market.

Key Takeaways

• FDA Approval: Myrbetriq Granules were approved by the FDA in March 2021 for treating NDO in children aged three years and older.
• Market Share: Mirabegron holds a significant market share of 27.6% in the overactive bladder treatment market.
• Competitive Edge: Fewer side effects and ease of administration make Myrbetriq Granules a preferred choice over anticholinergics.
• Financial Impact: The approval has positively impacted Astellas Pharma's financial forecast.
• Growth Drivers: Regulatory approvals, efficacy, safety, and ease of administration drive the growth of Myrbetriq Granules.
• Future Prospects: The market is expected to grow, with Myrbetriq Granules continuing to dominate due to ongoing clinical trials and expanded treatment indications.

FAQs

Q: What is Myrbetriq Granules used for? A: Myrbetriq Granules are used for the treatment of neurogenic detrusor overactivity (NDO) and overactive bladder (OAB) symptoms in pediatric patients aged three years and older.

Q: What is the significance of the FDA approval for Myrbetriq Granules? A: The FDA approval in March 2021 marked a significant milestone by introducing a new treatment option for NDO in children, a previously underserved patient population.

Q: How does Myrbetriq Granules compare to other treatments in the market? A: Myrbetriq Granules have fewer side effects compared to anticholinergics and are easier to administer, especially for pediatric patients who may have difficulty swallowing tablets.

Q: What are the growth drivers for Myrbetriq Granules in the market? A: Growth drivers include regulatory approvals, efficacy, safety, ease of administration, and favorable reimbursement policies.

Q: What are the future prospects for Myrbetriq Granules in the overactive bladder treatment market? A: The market is expected to grow, with Myrbetriq Granules continuing to dominate due to ongoing clinical trials and expanded treatment indications.

Sources

1. Astellas Pharma Inc. - News: Myrbetriq and Myrbetriq Granules Approved for Pediatric Patients with NDO[1].
2. Astellas Pharma Inc. - Press Release: Astellas Reports Full Year FY2016 Financial Results[2].
3. Grand View Research - Overactive Bladder Treatment Market Size Report, 2030[3].
4. Astellas Pharma Inc. - Annual Report 2017[4].
5. MarketsandMarkets - Overactive Bladder Treatment Market Size And Global Industry[5].