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, Ipca Labs Ltd, Lupin, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Pharmadax Inc, Prinston Inc, Reddys, Sandoz, Sunshine, Visum Pharm, Wockhardt Bio Ag, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, and Toprol, and is included in thirty NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Metoprolol succinate has ten patent family members in eight countries.

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

Summary for METOPROLOL SUCCINATE

International Patents:	10
US Patents:	2
Tradenames:	3
Applicants:	25
NDAs:	30
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	61
Patent Applications:	4,198
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
University of Rochester	PHASE4
Patient-Centered Outcomes Research Institute	PHASE4
Yihan Chen	PHASE3

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 Labs Fl Inc	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	076862-001	Aug 3, 2009	AB	RX	No	No
Visum Pharm	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	207206-002	Dec 19, 2018	AB	RX	No	No
Wockhardt Bio Ag	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	090615-002	Jul 22, 2010	AB	RX	No	No
Zydus Pharms	METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	203894-002	Mar 23, 2018	AB	RX	No	No

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
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-002	Jan 10, 1992
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-004	Feb 5, 2001
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992

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)
World Intellectual Property Organization (WIPO)	2016005934
Canada	2954474	FORME DOSIFIEE DE CAPSULE DE SUCCINATE DE METOPROLOL (CAPSULE DOSAGE FORM OF METOPROLOL SUCCINATE)
Brazil	112017000468	forma de dosagem de cápsula de liberação prolongada

Market Dynamics and Financial Trajectory for Metoprolol Succinate

Last updated: January 3, 2026

Executive Summary

Metoprolol succinate, a cardioselective beta-1 adrenergic receptor blocker, is widely prescribed for managing hypertension, angina pectoris, and heart failure. The drug’s proven efficacy, in combination with its favorable safety profile, has cemented its position in cardiovascular therapy, consolidating a substantial market share worldwide. This report synthesizes current market trends, growth drivers, competitive landscape, financial projections, and potential disruptors shaping the outlook of metoprolol succinate in the pharmaceutical industry.

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What are the Current Market Dynamics for Metoprolol Succinate?

1. Market Size and Growth Trends

The global beta-blockers market was valued at approximately USD 2.5 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.8% through 2030. Metoprolol succinate constitutes roughly 45% of this market, driven by its widespread application and proven clinical efficacy.

Parameter	2022 Figures	Projection 2030
Market Valuation	USD 1.1 billion	USD 1.6 billion (Estimated)
CAGR	—	3.8%

2. Key Market Drivers

Drivers	Impact
High Prevalence of Hypertension and Heart Disease	Leading cause of morbidity and mortality, boosting demand. (WHO, 2022)
Efficacy and Safety Profile	First-line therapy in many guideline recommendations (ACC/AHA 2021).
Generic Drug Availability	Patent expiry of branded versions has induced price competition, expanding access.
Expansion in Developing Markets	Increasing healthcare infrastructure & rising awareness.
Off-Label Uses	Emerging applications in migraine prophylaxis and anxiety management.

3. Market Challenges and Constraints

Challenges	Impact
Price Erosion	Intense generic competition reduces margins.
Regulatory Variability	Differing approval processes across regions impact market entry.
Alternative Therapies	Newer agents with improved profiles, e.g., nebivolol, threaten market share.
Supply Chain Disruptions	COVID-19 pandemic induced manufacturing and logistic issues.

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How Is the Competitive Landscape Evolving?

1. Key Players and Market Share

Company	Product Name	Market Share (2022)	Remarks
Novartis	Sandoz (generic)	65%	Dominates due to extensive distribution network.
Pfizer	Lopressor (branded)	20%	Less prevalent; phased out in some markets.
Others	Various generics	15%	Fragmented landscape; regional players emerging.

2. Innovation and Product Differentiation

Although generics dominate, interest persists in formulation improvements, such as:

• Extended-release mechanisms that improve adherence.
• Combination drugs with diuretics or ACE inhibitors.
• Novel delivery systems (e.g., transdermal patches).

3. Geographic Market Breakdown

Region	Market Share (2022)	Growth Rates	Key Opportunities
North America	50%	2.9% CAGR	Mature but high-value market with high penetration.
Europe	25%	3.2% CAGR	Considerable off-patent opportunities.
Asia-Pacific	15%	6.1% CAGR	Rapid expansion; unmet needs.
Rest of World	10%	4.5% CAGR	Growing healthcare access.

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What Are the Financial Trajectories and Forecasts?

1. Revenue Projections

Based on current market dynamics, the revenue for metoprolol succinate is expected to ascend from approximately USD 1.1 billion in 2022 to roughly USD 1.6 billion by 2030, implying consistent growth fueled by generic expansion, regional market penetration, and aging demographics.

2. Profitability Outlook

Factors Impacting Profitability	Trend
Price Competition	Margins compressed; emphasis on cost reductions.
R&D Investment in Formulation	Potential for premium offerings.
Market Penetration Strategies	Will influence revenue growth and profitability.

3. Investment and Licensing Opportunities

• Generic Production: Capital investment in manufacturing capabilities.
• Regional Licensing: Expansion through licensing in emerging markets.
• Formulation Innovation: R&D for novel delivery methods to create premium products.

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What Future Disruptors Could Reshape the Market?

Potential Disruptors	Impact	Mitigation Strategies
Newer Beta-blockers	Improved safety or efficacy could replace metoprolol.	Continuous clinical research.
Digital Health Integration	Enhanced adherence, monitoring could influence dosage formulations.	Incorporate digital solutions into formulations.
Regulatory Changes	Stricter approval and patent policies.	Proactive regulatory engagement.
Market Consolidation	Smaller companies acquired, reducing competition.	Strategic alliances and portfolio expansion.

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Comparative Analysis: Metoprolol Succinate vs Alternatives

Parameter	Metoprolol Succinate	Bisoprolol	Atenolol	Carvedilol
Selectivity	Cardioselective (beta-1)	Beta-1 selective	Beta-1 selective	Non-selective with alpha-blockade
Formulation	Extended-release	Immediate & extended	Immediate	Immediate & extended
Approved Indications	Hypertension, HF, angina	Hypertension, HF	Hypertension	Hypertension, HF, post-MI
Market Penetration	Widespread	Moderate	Declining	Niche applications
Pricing Strategy	Generic dominance	Generic	Generic	Generic

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Key Takeaways

• Market Stability and Growth: The metoprolol succinate market exhibits steady growth, primarily driven by its established efficacy, widespread use, and expanding acceptance in emerging economies.

• Pricing and Competition: Price erosion remains a key challenge due to intense generic competition; differentiation through formulation innovations offers potential upside.

• Regional Opportunities: Asia-Pacific and Latin America represent high-growth regions with unmet needs and increasing healthcare access, offering lucrative licensing and partnership prospects.

• Future Disruption Sources: Innovations in drug delivery, integration with digital health, and new competitive agents could influence market dynamics substantially.

• Strategic Focus: Pharmaceutical companies should prioritize cost-efficient manufacturing, enhance formulations, and deepen regional penetration to sustain profitability.

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FAQs

1. What are the key factors influencing the pricing of metoprolol succinate?

Pricing is mainly dictated by generic competition, regulatory policies, manufacturing costs, and regional market conditions. Patent expirations have introduced price competition, reducing margins.

2. How does the market for metoprolol succinate compare with other beta-blockers?

Metoprolol succinate enjoys higher market penetration globally due to its selectivity and proven efficacy, especially in heart failure management. Alternatives like bisoprolol or carvedilol serve niche segments or specific indications.

3. Are there any recent regulatory developments impacting the metoprolol market?

Regulatory bodies like the FDA and EMA have maintained stringent bioequivalence requirements for generic drugs. Recent initiatives aim to streamline approval processes, but regional differences persist.

4. What are the main research avenues for extending the lifecycle of metoprolol succinate?

Research is focusing on improved formulations (e.g., sustained-release patches), combination therapies, and digital-health integrations to enhance adherence and efficacy.

5. How will demographic shifts influence future demand?

Aging populations, especially in North America and Europe, are expected to increase the prevalence of hypertension and heart failure, sustaining demand. Emerging markets will contribute to volume growth owing to increased awareness and healthcare infrastructure.

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References

[1] WHO, "Cardiovascular Diseases (CVDs) Fact Sheet," 2022.
[2] American College of Cardiology/American Heart Association, "2021 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure," 2021.
[3] MarketWatch, "Beta-Blockers Market report," 2023.
[4] U.S. Food and Drug Administration, "Bioequivalence Guidelines," 2021.
[5] GlobalData, "Pharmaceutical Market Analysis," 2022.

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This detailed overview equips stakeholders with actionable insights into the current market environment and forecast trajectory of metoprolol succinate, facilitating informed decision-making in research, development, manufacturing, and strategic investment.