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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eleven patent family members in thirty countries.

The generic ingredient in MYRBETRIQ 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

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

Summary for MYRBETRIQ

International Patents:	111
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	51
Patent Applications:	220
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 ten US patents and two FDA Regulatory Exclusivities.

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
Apgdi	MYRBETRIQ GRANULES	mirabegron	FOR SUSPENSION, EXTENDED RELEASE;ORAL	213801-001	Mar 25, 2021		RX	Yes	Yes
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	AB	RX	Yes	Yes
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	AB	RX	Yes	Yes
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-002	Jun 28, 2012	AB	RX	Yes	Yes
Apgdi	MYRBETRIQ	mirabegron	TABLET, EXTENDED RELEASE;ORAL	202611-001	Jun 28, 2012	AB	RX	Yes	Yes

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	202611-002	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	202611-001	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/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

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
South Korea	20050040837
Canada	2387705	COMPOSITION PHARMACEITIQUE STABLE POUR ADMINISTRATION ORALE (STABLE PHARMACEUTICAL COMPOSITION FOR ORAL USE)
Canada	2704298	COMPOSITION PHARMACEUTIQUE POUR TRAITER UNE VESSIE HYPERACTIVE (PHARMACEUTICAL COMPOSITION FOR TREATING OVERACTIVE BLADDER)
Hungary	T72324
European Patent Office	3827826	COMPOSITION PHARMACEUTIQUE À LIBÉRATION MODIFIÉE (PHARMACEUTICAL COMPOSITION FOR MODIFIED RELEASE)
Japan	WO2009057685	過活動膀胱治療用医薬組成物

Supplementary Protection Certificates for MYRBETRIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1028111	300598	Netherlands		PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220
1559427	457	Finland
1559427	13C0032	France		PRODUCT NAME: MIRABEGRON ET SES SELS; REGISTRATION NO/DATE: EU/1/12/809/001 20130107
1559427	132013902166933	Italy		PRODUCT NAME: MIRABEGRON(BETMIGA); AUTHORISATION NUMBER(S) AND DATE(S): 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	33/2013	Austria		PRODUCT NAME: MIRABEGRON ODER DESSEN SALZE; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220

MYRBETRIQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Myrbetriq

Introduction to Myrbetriq

Myrbetriq, also known by its generic name mirabegron, is a beta-3 adrenergic receptor agonist used in the treatment of overactive bladder (OAB). It was approved by the FDA in 2012 and has since become a leading therapy in the OAB market.

Market Position and Sales

Myrbetriq currently holds a significant market share in the OAB treatment market. As of 2020, it accounted for more than 50% of the global OAB market sales, making it the leading OAB therapy[1][4].

Global Sales and Revenue

The global sales of Myrbetriq have been substantial, contributing significantly to the overall OAB drug market. In 2020, the global OAB market sales were valued at $2.2 billion, with Myrbetriq being a major contributor to this figure. The market is projected to grow from $2.2 billion in 2020 to $2.8 billion by 2030, with Myrbetriq expected to maintain its dominant position[1][4].

Growth Rate and Forecast

The OAB drug market, driven in part by Myrbetriq, is forecasted to grow at a Compound Annual Growth Rate (CAGR) of more than 2% from 2021 to 2030. This growth is expected despite some challenges, such as patent expirations and generic sales erosion, which will impact the market in the early-to-mid forecast period[1][4].

Key Drivers and Barriers

Drivers

• The continued uptake of Myrbetriq and other beta-3 agonists like Gemtesa (vibegron) in key markets such as the US and Japan is a significant driver. The potential launch of Gemtesa in China and other pipeline products will also boost market sales in the mid-to-late forecast period[1].
• Increasing prevalence of OAB due to aging populations and rising obesity rates will expand the treatment pool, benefiting Myrbetriq and other OAB therapies[1][4].

Barriers

• Patent expirations of key products, including Myrbetriq, will lead to generic sales erosion, particularly in the early-to-mid forecast period. This will temporarily constrain market growth[1][4].
• Low rates of diagnosis and treatment due to stigma and misinformation surrounding OAB, as well as poor persistence and adherence to drug therapy, are significant barriers to market growth[1].

Regional Performance

US Market

The US is the largest market for OAB drugs, with Myrbetriq playing a crucial role. The high cost of drug therapy and the large prevalence population in the US contribute to its significant market share[1].

Other Regions

While the US dominates, other regions such as the 5EU (France, Germany, Italy, Spain, and the UK) and Japan also contribute to the sales of Myrbetriq. The potential launch of new products in these regions will further drive growth[1].

Competitive Landscape

Myrbetriq operates in a competitive landscape with other OAB treatments, including antimuscarinics and newer therapies. Key players in the OAB market include Allergan, Astellas, Pfizer, Urovant Sciences, Bayer, and Taiho Pharmaceuticals. The market is expected to see the launch of novel therapies, such as Bayer’s P2X purinoceptor 3 (P2RX3) antagonist Eliapixant and Urovant Sciences’ gene therapy URO-902, which could impact Myrbetriq’s market share[1].

Financial Performance of Astellas

Astellas, the manufacturer of Myrbetriq, has seen varied financial performance in recent years. While the company's revenue has increased, operating profit and core profit have declined due to factors such as increased selling, general, and administrative expenses, and significant amortization of intangible assets. However, Myrbetriq remains a key contributor to Astellas' revenue, with sales of BETANIS / MYRBETRIQ / BETMIGA showing stable performance[2][5].

Future Outlook

The future outlook for Myrbetriq is mixed. While it is expected to continue as a leading therapy in the OAB market, the impact of patent expirations and the launch of new pipeline products will shape its market share. The increasing prevalence of OAB and the focus on enhancing patient outcomes will drive overall market growth, but Myrbetriq's specific trajectory will depend on its ability to maintain market share against new competitors.

Key Takeaways

• Myrbetriq is the leading OAB therapy, accounting for over 50% of the global OAB market sales.
• The OAB market is projected to grow at a CAGR of more than 2% from 2021 to 2030.
• Patent expirations and generic sales erosion are significant barriers to market growth.
• Increasing prevalence of OAB due to aging populations and rising obesity rates will expand the treatment pool.
• The US is the largest market for OAB drugs, with Myrbetriq playing a crucial role.

FAQs

Q: What is the current market share of Myrbetriq in the OAB treatment market? A: Myrbetriq currently accounts for more than 50% of the global OAB market sales.

Q: What is the projected growth rate of the OAB drug market from 2021 to 2030? A: The OAB drug market is projected to grow at a CAGR of more than 2% from 2021 to 2030.

Q: What are the major drivers of market growth for Myrbetriq and other OAB therapies? A: The continued uptake of beta-3 agonists, potential launches of pipeline products, and increasing prevalence of OAB due to aging populations and rising obesity rates are major drivers.

Q: What are the significant barriers to market growth for Myrbetriq? A: Patent expirations, generic sales erosion, low rates of diagnosis and treatment due to stigma, and poor persistence and adherence to drug therapy are significant barriers.

Q: Which region dominates the market for OAB drugs, including Myrbetriq? A: The US is the largest market for OAB drugs, including Myrbetriq, due to the high cost of drug therapy and the large prevalence population.

Sources

1. GlobalData: Overactive Bladder: Global Drug Forecast and Market Analysis to 2030.
2. Astellas: Financial Results of Astellas for the First Nine Months of FY2023.
3. Vision Research Reports: Overactive Bladder Treatment Market Size, Growth, Trends, Report.
4. Business Wire: Global Overactive Bladder Drug Forecast and Market Analysis Report 2021-2030.
5. Astellas: Financial Results of Astellas for Fiscal Year 2023.