METOPROLOL SUCCINATE - Generic Drug Details

What are the generic drug sources for metoprolol succinate and what is the scope of freedom to operate?

Metoprolol succinate is the generic ingredient in three branded drugs marketed by Spil, Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Alkem Labs Ltd, Cipla, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd Iii, Lupin, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Pharmadax Inc, Prinston Inc, Reddys, Sandoz, Sunshine, Visum Pharm, Wockhardt, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, and Toprol, and is included in twenty-nine NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Metoprolol succinate has eight patent family members in seven countries.

There are thirty drug master file entries for metoprolol succinate. Forty-eight suppliers are listed for this compound.

Summary for METOPROLOL SUCCINATE

International Patents:	8
US Patents:	2
Tradenames:	3
Applicants:	24
NDAs:	29
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	58
Patent Applications:	2,302
Drug Prices:	Drug price trends for METOPROLOL SUCCINATE
Drug Sales Revenues:	Drug sales revenues for METOPROLOL SUCCINATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METOPROLOL SUCCINATE
What excipients (inactive ingredients) are in METOPROLOL SUCCINATE?	METOPROLOL SUCCINATE excipients list
DailyMed Link:	METOPROLOL SUCCINATE at DailyMed

See drug prices for METOPROLOL SUCCINATE

See drug sales revenues for METOPROLOL SUCCINATE

Recent Clinical Trials for METOPROLOL SUCCINATE

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

Sponsor	Phase
VA Office of Research and Development	Phase 3
Cytokinetics	Phase 3
Yang I. Pachankis	Phase 4

See all METOPROLOL SUCCINATE clinical trials

Pharmacology for METOPROLOL SUCCINATE

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for METOPROLOL SUCCINATE

C07AB	Beta blocking agents, selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for METOPROLOL SUCCINATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Elizabeth	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	204161-003	Nov 25, 2016	AB	RX	No	No
Zydus Pharms	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	203894-003	Mar 23, 2018	AB	RX	No	No
Sunshine	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	214004-001	Sep 26, 2022	AB	RX	No	No
Reddys	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	078889-002	Aug 15, 2012	AB	RX	No	No
Sandoz	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	076969-004	Mar 20, 2008		DISCN	No	No
Actavis Elizabeth	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	204161-002	Nov 25, 2016	AB	RX	No	No
Spil	KAPSPARGO SPRINKLE	metoprolol succinate	CAPSULE, EXTENDED RELEASE;ORAL	210428-002	Jan 26, 2018		RX	Yes	No	9,504,655		Y

Expired US Patents for METOPROLOL SUCCINATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992	5,001,161*PED
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-001	Jan 10, 1992	5,001,161*PED
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-002	Jan 10, 1992	5,001,161*PED
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992	4,927,640*PED
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992	5,081,154*PED
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-002	Jan 10, 1992	3,998,790
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-004	Feb 5, 2001	5,246,714*PED

International Patents for METOPROLOL SUCCINATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3166599	FORME DOSIFIÉE DE CAPSULE DE SUCCINATE DE MÉTOPROLOL (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE)
Australia	2015287299	Capsule dosage form of metoprolol succinate
Japan	2017523164	コハク酸メトプロロールのカプセル剤形
Mexico	2017000384	FORMA DE DOSIFICACION EN CAPSULAS DE SUCCINATO DE METOPROLOL. (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE.)
Canada	2954474	FORME DOSIFIEE DE CAPSULE DE SUCCINATE DE METOPROLOL (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE)
Japan	6626492
World Intellectual Property Organization (WIPO)	2016005934

METOPROLOL SUCCINATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metoprolol Succinate

Introduction to Metoprolol Succinate

Metoprolol succinate is a widely used beta-blocker, primarily prescribed for the management of hypertension, angina, and heart failure. Its efficacy in reducing myocardial contractility, heart rate, and blood pressure makes it a crucial medication in cardiovascular care[2].

Global Market Size and Growth

The global metoprolol succinate market is projected to experience significant growth over the next few years. As of 2024, the market size is estimated to be USD XX million, with a forecasted compound annual growth rate (CAGR) of 4.70% from 2024 to 2031. This growth is driven by the increasing prevalence of cardiovascular diseases and the expanding healthcare infrastructure globally[1].

Regional Market Dynamics

North America

North America holds a major share of the global metoprolol succinate market, with over 40% of the global revenue. The region is expected to grow at a CAGR of 2.9% from 2024 to 2031. The United States and Canada are key contributors, with the U.S. market growing at a CAGR of 2.7% and Canada at 3.7% during the same period[1].

Europe

Europe accounts for around 30% of the global revenue, with a CAGR of 3.2% from 2024 to 2031. The region's aging population and high incidence of cardiovascular diseases are significant factors driving this growth[1].

Asia-Pacific

The Asia-Pacific region is expected to witness the highest growth, with a CAGR of 6.7% from 2024 to 2031. This is attributed to the rising occurrence of cardiovascular illnesses, improved healthcare access, and growing awareness of chronic condition management. The aging population and the development of generics in this region also contribute to the market expansion[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa hold smaller but significant shares of the global market. Latin America is expected to grow at a CAGR of 4.1%, while the Middle East & Africa will grow at a CAGR of 4.4% from 2024 to 2031[1].

Competitive Landscape

The metoprolol succinate market is highly competitive, with several key players including Lannett, Hema Pharmaceuticals, Ravoos Laboratories Limited, AstraZeneca, Tecoland, and SURYA LIFE SCIENCES. The competition is intensified by the availability of generic versions of the drug, which has driven prices down and created a more aggressive market environment. This competition compels manufacturers to optimize production methods, reduce costs, and innovate to differentiate their products[1][4].

Pricing Strategies and Market Impact

The competitive nature of the market has led to significant price pressure. While lower drug prices benefit consumers, they challenge manufacturers to maintain profitability. Pricing strategies have become critical for sustaining market share and revenue margins. The availability of generic metoprolol succinate has particularly driven down prices, making it essential for branded manufacturers to focus on product differentiation and quality to retain market share[1].

Applications and Types

Metoprolol succinate is primarily used for treating hypertension, angina, and other cardiovascular conditions. The drug is available in various dosages, including 25mg, 50mg, 100mg, and 200mg. The versatility in dosing options allows for tailored treatment plans, which is a key factor in its widespread adoption[4].

Clinical Recommendations and Guidelines

Clinical guidelines strongly recommend the use of metoprolol succinate in patients with left ventricular dysfunction or systolic heart failure. The 2019 ESC guidelines emphasize the importance of beta-blockers, including metoprolol succinate, in reducing the risk of major adverse cardiovascular events (MACE) in patients with chronic coronary disease (CCD) and left ventricular ejection fraction (LVEF) ≤50%[2].

Financial Trajectory

The financial trajectory of the metoprolol succinate market is positive, driven by increasing demand and expanding healthcare access. The market is expected to grow from USD XX million in 2024 to USD XX million by 2031, with a CAGR of 4.70%. This growth is supported by the rising prevalence of cardiovascular diseases and the ongoing development of healthcare infrastructure, particularly in the Asia-Pacific region[1].

Challenges and Opportunities

Challenges

• Price Competition: The presence of generic versions and multiple manufacturers has led to significant price competition, affecting revenue margins.
• Regulatory Environment: Strict regulatory requirements and the need for continuous innovation to differentiate products pose challenges.
• Financial Barriers: High out-of-pocket costs for patients can limit access to the medication, despite its clinical benefits[5].

Opportunities

• Growing Demand: The increasing prevalence of cardiovascular diseases globally presents a significant opportunity for market growth.
• Emerging Markets: The Asia-Pacific region, with its growing healthcare infrastructure and aging population, offers substantial growth potential.
• Innovation: The need to differentiate products provides opportunities for innovation in formulation, delivery, and patient care services[1].

Key Takeaways

• The global metoprolol succinate market is expected to grow at a CAGR of 4.70% from 2024 to 2031.
• North America and Europe hold significant market shares, but the Asia-Pacific region is expected to experience the highest growth.
• The competitive landscape is driven by price pressure and the availability of generic versions.
• Clinical guidelines strongly support the use of metoprolol succinate in cardiovascular care.
• Financial barriers and regulatory challenges must be navigated to capitalize on market opportunities.

FAQs

Q: What is the projected CAGR for the global metoprolol succinate market from 2024 to 2031? A: The global metoprolol succinate market is expected to grow at a CAGR of 4.70% from 2024 to 2031[1].

Q: Which region is expected to witness the highest growth in the metoprolol succinate market? A: The Asia-Pacific region is expected to witness the highest growth, with a CAGR of 6.7% from 2024 to 2031[1].

Q: What are the primary applications of metoprolol succinate? A: Metoprolol succinate is primarily used for treating hypertension, angina, and other cardiovascular conditions[4].

Q: Who are the key players in the metoprolol succinate market? A: Key players include Lannett, Hema Pharmaceuticals, Ravoos Laboratories Limited, AstraZeneca, Tecoland, and SURYA LIFE SCIENCES[4].

Q: What are the main challenges facing manufacturers in the metoprolol succinate market? A: The main challenges include price competition, regulatory requirements, and financial barriers to patient access[1][5].

Cited Sources

1. Cognitive Market Research: Metoprolol Succinate Market Report 2024 (Global Edition)[1].
2. ACC Journal: Beta-blocker therapy in patients with acute myocardial infarction[2].
3. DataIntelo: Metoprolol Succinate Market Report | Global Forecast From 2023 To ...[3].
4. Valuates Reports: Global Metoprolol Succinate Market Research Report 2024[4].
5. ACC.org: Inpatient Initiation of HFrEF Therapies[5].