ATROMID-S Drug Patent Profile

Which patents cover Atromid-s, and when can generic versions of Atromid-s launch?

Atromid-s is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in ATROMID-S is clofibrate. There are four drug master file entries for this compound. Additional details are available on the clofibrate profile page.

Summary for ATROMID-S

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	94
Patent Applications:	2,576
DailyMed Link:	ATROMID-S at DailyMed

US Patents and Regulatory Information for ATROMID-S

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	ATROMID-S	clofibrate	CAPSULE;ORAL	016099-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for ATROMID-S (Atorvastatin)

Last updated: July 29, 2025

Introduction

ATROMID-S, a branded formulation of atorvastatin, is positioned within the highly competitive statin segment targeting hyperlipidemia and cardiovascular risk management. As a well-established therapy, atorvastatin is among the world's top-selling pharmaceuticals. Understanding its market dynamics and potential financial trajectory requires analyzing current demand drivers, competitive landscape, regulatory considerations, and evolving healthcare trends.

Pharmaceutical Overview

ATROMID-S (atorvastatin calcium) is a lipid-lowering agent that inhibits HMG-CoA reductase, reducing LDL cholesterol and triglycerides. Approved initially in 1996, atorvastatin’s long market presence owes to its proven efficacy, safety profile, and patent expiry, making it a staple prescription globally. Despite the introduction of generic competitors, branded formulations like ATROMID-S remain relevant due to brand loyalty, physician prescribing habits, and regional regulatory strategies.

Market Drivers

1. Rising Cardiovascular Disease Burden

World Health Organization data indicates cardiovascular disease (CVD) accounts for approximately 32% of global deaths, with dyslipidemia being a modifiable risk factor[1]. Increasing prevalence in developing regions driven by urbanization, dietary shifts, and aging populations fuels demand for lipid management therapies, including atorvastatin-based products like ATROMID-S.

2. Expansion in Developing Markets

Emerging economies, notably India, China, and Brazil, witness rising healthcare access and increasing adoption of lipid-lowering drugs. Governments and insurers' incentivization of cost-effective treatments enhance penetration of generic atorvastatin formulations, positioning ATROMID-S as an attractive option.

3. Outlook for Cardiovascular Risk Management

Growing awareness among physicians and patients about preventive cardiology spurs prescription growth. Preventive use of statins aligns with contemporary guidelines from American College of Cardiology/American Heart Association (ACC/AHA), reinforcing demand.

4. Patent and Regulatory Landscape

While patent expirations have facilitated generic entry, regional approvals and brand-specific formulations like ATROMID-S retain market presence through branding, clinician preference, and distribution networks.

Market Challenges

1. Generic Competition

The patent expiration of atorvastatin in various jurisdictions led to an influx of low-cost generics, exerting price pressure on ATROMID-S. Market share erosion is notable, especially in price-sensitive regions[2].

2. Pricing and Reimbursement Policies

Price controls and reimbursement policies in countries like India and the EU influence profitability. Manufacturers must navigate complex regulatory environments to sustain margins.

3. Alternative Therapies

Newer lipid-modifying agents and combination therapies (e.g., PCSK9 inhibitors, ezetimibe) offer alternatives, particularly for high-risk or statin-intolerant populations.

4. Market Saturation and Physician Preferences

In mature markets, prescription growth plateaus. Physician adherence to guideline-based prescribing and preference for generic affordability impact brand-specific revenues.

Financial Trajectory Analysis

1. Revenue Projections

Historically, atorvastatin peaked as the top-selling drug globally, achieving sales exceeding $13 billion annually at its height[3]. Post-patent expiry, revenues declined due to generics, yet branded formulations like ATROMID-S maintain profitability in niche segments or premium markets.

Current projections suggest a gradual decline in global revenues for ATROMID-S over the next 5 years, primarily driven by generic substitution. However, specialized markets, such as Japan and certain European countries, where brand loyalty persists, could sustain moderate revenue streams. Additionally, incremental revenues may arise from value-added formulations, fixed-dose combinations, or regional marketing strategies emphasizing quality differentiation.

2. Cost Implications and Profitability

Manufacturing costs for generic atorvastatin are relatively low, but marketing, distribution, and regulatory compliance incur significant expenses. Revenue erosion necessitates strategic cost management. Companies investing in brand retention, patient adherence programs, and regional market penetration will be better positioned to sustain margins.

3. Strategic Opportunities

• Market Segmentation: Target niche markets with higher willingness-to-pay, such as private healthcare segments or regions with limited generic penetration.
• Line Extensions: Developing combination products (e.g., atorvastatin plus ezetimibe) can bolster sales.
• Regulatory and Patent Strategies: Registering new formulations or delivery methods attuned to regional demands may provide temporary exclusivity.

Regional Market Insights

North America

Reimbursement frameworks and clinical guidelines favor statin use. Despite intense generic competition, the brand retains select market segments through physician advocacy and patient trust[4].

Europe

Mature market with high generic penetration. Market share is largely dependent on regional healthcare policies and physician prescribing behavior[5].

Asia-Pacific

Rapid growth driven by urbanization, aging populations, and increased cardiovascular disease prevalence. Regulatory pathways favor faster approval, enabling targeted marketing for premium formulations.

Latin America

Emerging market with expanding access; price sensitivity remains dominant, challenging branded product sales.

Regulatory and Patent Outlook

Patent landscapes influence product positioning. The U.S. patent for atorvastatin expired in 2011[6], prompting generic dominance. Regional regulatory approvals depend on local IP rights and approval processes, influencing market exclusivity periods.

Competitive Landscape

Key competitors include multinationals like Mylan, Teva, and local manufacturers offering low-cost generics. Brand differentiation focuses on quality assurance, clinical support, and regional distribution networks. A few companies explore innovative formulations or delivery systems to regain competitive advantages.

Conclusion

The market dynamics for ATROMID-S mirror those of other branded atorvastatin products: a shift from growth to mature, highly competitive status. While current revenues face erosion in the wake of generic competition, targeted strategies—focusing on niche markets, regulatory advantages, and product line extensions—offer avenues for sustained profitability. The future trajectory will depend heavily on regional healthcare policy changes, physician prescribing behaviors, and the evolution of competing therapies.

Key Takeaways

• The global atorvastatin market is mature, with declining revenues for branded formulations due to generic competition.
• Developing regions and niche markets remain opportunities for ATROMID-S to maintain a foothold through differentiation and targeted marketing.
• Strategic diversification into fixed-dose combinations and innovative formulations can offset revenue declines.
• Healthcare policies and regulatory frameworks significantly influence regional market prospects.
• Cost management, effective distribution, and physician engagement are critical to maximizing profitability amid intensifying price competition.

FAQs

1. How does ATROMID-S differentiate itself from generic atorvastatin products?
ATROMID-S leverages brand trust, consistent quality standards, and regional marketing strategies to retain customer loyalty in select markets, differentiating from generic counterparts priced lower but often perceived as lower quality.

2. What regions present the most promising growth opportunities for ATROMID-S?
Emerging markets in Asia-Pacific, particularly India and China, offer expansion potential driven by increasing cardiovascular disease prevalence, rising healthcare access, and favorable regulatory environments.

3. How will patent expirations impact ATROMID-S revenues?
Patent expirations facilitate generic competition, leading to significant revenue declines. Strategic approaches such as product line extensions and regional exclusivity efforts can mitigate these effects.

4. What role do regulatory policies play in shaping ATROMID-S’s market prospects?
Regulatory frameworks influence product approvals, market entry timelines, and pricing strategies, directly impacting sales opportunities, especially in regions with aggressive price controls.

5. Are there emerging therapies that threaten ATROMID-S’s market share?
Yes. New lipid-lowering agents like PCSK9 inhibitors and combination therapies provide alternatives for certain patient populations, potentially reducing reliance on statins and impacting sales of traditional formulations like ATROMID-S.

---

References
[1] World Health Organization. (2021). Cardiovascular diseases (CVDs).
[2] IMS Health. (2019). Global Data on Generic Drug Market Trends.
[3] EvaluatePharma. (2022). Top Drugs by Sales - 2021.
[4] CDC. (2020). Statin Use for the Primary Prevention of Cardiovascular Disease.
[5] European Medicines Agency. (2021). Market Approvals and Regulations.
[6] U.S. Patent and Trademark Office. (2011). Patent for atorvastatin expired.