Metoprolol tartrate - Generic Drug Details

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

Metoprolol tartrate is the generic ingredient in two branded drugs marketed by Novartis, Am Regent, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland, Hikma, Hikma Farmaceutica, Hospira, Luitpold, Onesource Specialty, Sandoz, Watson Labs, Rubicon Research, Validus Pharms, Xtm Consulting, Alembic Pharms Ltd, Apothecon, Aurobindo Pharma, Chartwell Rx, Heritage Pharma, Ipca Labs Ltd, Mylan, Pharmobedient, Purepac Pharm, Renata, Sciegen Pharms Inc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, and Zydus Pharms, and is included in thirty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for metoprolol tartrate. Fifty-one suppliers are listed for this compound.

Summary for metoprolol tartrate

US Patents:	0
Tradenames:	2
Applicants:	31
NDAs:	37
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	28
Drug Prices:	Drug price trends for metoprolol tartrate
Drug Sales Revenues:	Drug sales revenues for metoprolol tartrate
What excipients (inactive ingredients) are in metoprolol tartrate?	metoprolol tartrate excipients list
DailyMed Link:	metoprolol tartrate at DailyMed

See drug prices for metoprolol tartrate

See drug sales revenues for metoprolol tartrate

Recent Clinical Trials for metoprolol tartrate

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

Sponsor	Phase
VZW Cardiovascular Research Center Aalst	PHASE4
Yihan Chen	PHASE3
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Phase 3

See all metoprolol tartrate clinical trials

Pharmacology for metoprolol tartrate

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

Anatomical Therapeutic Chemical (ATC) Classes for metoprolol tartrate

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

US Patents and Regulatory Information for metoprolol tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rubicon Research	METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	200981-003	Oct 28, 2014	AB	RX	No	No
Hikma	METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	076495-001	Jul 7, 2003	AP	RX	No	No
Apothecon	METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	074258-002	Jan 27, 1994		DISCN	No	No
Renata	METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	074453-002	Apr 27, 1995	AB	RX	No	No
Sun Pharm Inds Inc	METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	076670-001	Jan 15, 2004		DISCN	No	No
Ipca Labs Ltd	METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	078459-002	Jun 17, 2008	AB	RX	No	No
Am Regent	METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	090386-001	Sep 30, 2009		DISCN	No	No

Expired US Patents for metoprolol tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	LOPRESSOR	metoprolol tartrate	INJECTABLE;INJECTION	018704-001	Mar 30, 1984	3,876,802
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-002	Approved Prior to Jan 1, 1982	3,998,790
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-001	Approved Prior to Jan 1, 1982	3,998,790
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-002	Approved Prior to Jan 1, 1982	3,876,802
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-001	Approved Prior to Jan 1, 1982	3,876,802
Novartis	LOPRESSOR	metoprolol tartrate	INJECTABLE;INJECTION	018704-001	Mar 30, 1984	3,998,790

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: Metoprolol Tartrate

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Introduction

Metoprolol tartrate, a beta-1 selective adrenergic receptor blocker, commands a pivotal position in cardiovascular therapeutics. Approved initially in the late 20th century, it remains a cornerstone in managing hypertension, angina pectoris, and heart failure. Understanding its market landscape and financial outlook involves a comprehensive analysis of clinical demand, competitive forces, regulatory considerations, and evolving healthcare paradigms.

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Market Overview and Demand Drivers

Clinical Use and Therapeutic Role

Metoprolol tartrate is prescribed predominantly for hypertension and ischemic heart diseases. Its ease of administration, proven efficacy, and favorable safety profile underpin sustained demand. As per IQVIA reports, beta-blockers constitute a significant segment of cardiovascular medications, with metoprolol representing an approximately 25% share within this class globally [1].

Prevalence of Cardiovascular Diseases

The rising global burden of cardiovascular disease (CVD), projected to afflict over 1.4 billion people by 2030, sustains the therapeutic need for agents like metoprolol [2]. Aging populations in North America, Europe, and parts of Asia escalate prescription volumes.

Off-Label and Combination Use

Off-label utilization in arrhythmias and prophylactic migraine treatment, alongside combination therapies, also bolster volumes. The pharmaceutical interest pivots around such flexible applications, where patent protection no longer constraints market expansion.

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Market Dynamics Influencers

Generic Competition and Market Penetration

Metoprolol tartrate's patent expired in the early 2000s, drastically increasing generic entry. Generic versions have maintained aggressive pricing strategies, constraining branded sales growth but expanding access and compliance due to lower costs. As a result, the market is predominantly driven by biosimilar and generic availability, pressuring profit margins for branded formulations.

Manufacturing and Supply Chain Factors

The production of metoprolol tartrate involves established synthesis pathways, but recent shortages—due to raw material disruptions, regulatory compliance issues, or manufacturing outages—have occasionally constrained supply. Such disruptions can momentarily influence pricing and procurement strategies, especially in emerging markets.

Regulatory Environment

Regulatory bodies like the FDA and EMA have streamlined approval pathways for generics, facilitating market entry and wider distribution channels. Conversely, evolving regulations around biosimilars, patent litigations, and quality standards influence competitive dynamics.

Emerging Markets and Demographic Trends

Emerging economies, particularly in Asia and Latin America, exhibit escalating uptake owing to increasing CVD prevalence and expanding healthcare infrastructure. Market penetration is further facilitated by local manufacturing, licensing agreements, and government-led initiatives for affordable medications.

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Financial Trajectory and Growth Opportunities

Revenue Trends and Projections

Global sales of metoprolol tartrate hovered around USD 1.2 billion in 2022, with a compound annual growth rate (CAGR) of approximately 3% over the past five years, primarily due to generic proliferation and pricing pressures [3]. While branded sales have plateaued, volume-driven growth remains viable owing to widespread adoption and population aging.

Pricing Strategies and Margins

Pricing is heavily influenced by generic competition; thus, profit margins are concentrated among early entrant manufacturers and regional players with lower cost structures. The shift towards biosimilars and generics sustains somewhat stable revenue streams despite intense price erosion.

Pipeline and Future Developments

Currently, no significant novel formulations or extended-release variants of metoprolol tartrate are in advanced development. However, innovations combining beta-blockers with novel agents or delivery systems could create targeted niche markets, potentially fostering incremental revenues.

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Market Challenges and Risks

• Intense Price Competition: High generic penetration constricts revenue streams, compelling manufacturers to optimize operational efficiencies.
• Regulatory Barriers: Stringent quality standards and patent litigations can delay market entry of new competitors or formulations.
• Evolving Therapeutic Guidelines: The emergence of novel antihypertensives and device-based treatments might reduce reliance on traditional beta-blockers.
• Supply Chain Risks: Raw material shortages and manufacturing disruptions could impact availability, especially in low-income regions.

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Strategic Outlook and Recommendations

• Focus on Cost Optimization: To sustain margins amid price erosion, manufacturers should streamline production and logistics.
• Diversify Portfolio: Introducing combination formulations or new delivery methods may mitigate risks associated with patent expiry.
• Expand in Emerging Markets: Tailored strategies to penetrate rapidly growing economies can sustain long-term revenue growth.
• Engage in Pharmacovigilance and Compliance: Maintaining regulatory alignment ensures uninterrupted market access.

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Key Takeaways

• The global metoprolol tartrate market remains sizeable, driven by widespread use in cardiovascular conditions and demographic aging.
• Patent expirations and generic competition dominate the landscape, suppressing branded revenues but expanding access.
• Market growth pivots around demand in emerging markets, demographic shifts, and off-label applications.
• Price pressure necessitates operational efficiencies and product diversification to sustain profitability.
• Future opportunities lie in novel formulations, combination drugs, and strategic regional expansion, especially in markets with rising CVD burdens.

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FAQs

1. What factors primarily influence the pricing of metoprolol tartrate in different markets?
Pricing is influenced by patent status, generic competition, regulatory standards, healthcare policies, and market-specific purchasing power.

2. How does patent expiration impact the financial trajectory of metoprolol tartrate?
Patent expiry typically leads to entry of generics, reducing branded drug revenues but expanding overall market volume and access, ultimately stabilizing or decreasing unit prices.

3. Are there any promising developments or alternative formulations for metoprolol tartrate?
While current pipelines lack major innovations, combination drugs and extended-release formulations could offer limited growth opportunities.

4. How does the rise of biosimilars and advanced antihypertensive agents influence the metoprolol market?
These developments intensify competition and may shift prescribing patterns, but metoprolol's established efficacy ensures continued relevance.

5. What strategies can pharmaceutical companies adopt to enhance profitability in this mature market?
Focusing on operational efficiencies, regional expansion, product line diversification, and exploring niche applications can offset declining margins.

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References

[1] IQVIA. (2022). Global Cardiovascular Market Trends.
[2] World Health Organization. (2021). Cardiovascular Diseases Fact Sheet.
[3] MarketWatch. (2023). Metoprolol Tartrate Market Size and Forecast.