ALTOPREV Drug Patent Profile

Which patents cover Altoprev, and what generic alternatives are available?

Altoprev is a drug marketed by Covis and is included in one NDA.

The generic ingredient in ALTOPREV is lovastatin. There are thirty-three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the lovastatin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Altoprev

A generic version of ALTOPREV was approved as lovastatin by ACTAVIS ELIZABETH on December 17^th, 2001.

Summary for ALTOPREV

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Drug Prices:	Drug price information for ALTOPREV
What excipients (inactive ingredients) are in ALTOPREV?	ALTOPREV excipients list
DailyMed Link:	ALTOPREV at DailyMed

See drug prices for ALTOPREV

Recent Clinical Trials for ALTOPREV

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 4
Amgen	Phase 4
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2

See all ALTOPREV clinical trials

US Patents and Regulatory Information for ALTOPREV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-001	Jun 26, 2002		DISCN	No	No
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-004	Jun 26, 2002		DISCN	Yes	No
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-002	Jun 26, 2002		DISCN	Yes	No
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-003	Jun 26, 2002		DISCN	Yes	No

Expired US Patents for ALTOPREV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-003	Jun 26, 2002
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-004	Jun 26, 2002
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-004	Jun 26, 2002
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-001	Jun 26, 2002
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-002	Jun 26, 2002
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-002	Jun 26, 2002

International Patents for ALTOPREV

See the table below for patents covering ALTOPREV around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2371748	HMG-COA reductase inhibitor extended release formulation
United Kingdom	0210619
Spain	2252872
World Intellectual Property Organization (WIPO)	9948488
New Zealand	530584	HMG-COA reductase inhibitor extended release formulation
World Intellectual Property Organization (WIPO)	9930692

Market Dynamics and Financial Trajectory for ALTOPREV (Pravastatin Sodium)

Last updated: July 27, 2025

Introduction

ALTOPREV, a branded formulation of pravastatin sodium, is a widely used statin prescribed for managing hyperlipidemia and preventing cardiovascular disease. As a member of the HMG-CoA reductase inhibitors class, pravastatin's market positioning is shaped by evolving regulatory landscapes, competitive dynamics, technological innovations, and health-economic factors. This analysis explores the current market environment and forecasts the financial trajectory of ALTOPREV over the coming years.

Market Overview

Pharmacological Profile and Therapeutic Use

ALTOPREV's active ingredient, pravastatin sodium, effectively reduces low-density lipoprotein cholesterol (LDL-C) levels. Its role in secondary prevention of coronary artery disease (CAD) has propelled its steady demand globally. The drug's safety profile, established over decades, enhances its appeal; however, newer statins with higher potency have gained market share, influencing ALTOPREV's positioning.

Global Market Size and Trends

The global statin market, valued at approximately USD 10 billion in 2022, is projected to grow at a CAGR of about 3.5% through 2030 (source: MarketWatch). Factors contributing to growth include rising cardiovascular disease prevalence, lipid management awareness, and expanding healthcare infrastructure, especially in developing regions.

Market Dynamics

Regulatory and Patent Landscape

ALTOPREV benefits from a long-standing patent protection period, but many patents have expired or are nearing expiration, exposing the drug to generic competition. Patent expirations typically precipitate a sharp decline in revenue due to price erosion and market share loss to generics. Patent cliffs for pravastatin occurred globally around 2016-2018, intensifying market competition.

Regulatory frameworks increasingly favor biosimilars and generics, ensuring easier market entry post-patent expiry. Additionally, health agencies have begun emphasizing cost-effectiveness, potentially impacting the reimbursement landscape for branded formulations like ALTOPREV.

Competitive Landscape

The competitive frame comprises several high-potency statins, including atorvastatin, rosuvastatin, and simvastatin. These agents often surpass pravastatin in LDL-C lowering capacity, leading physicians to prefer these alternatives, especially in high-risk patients.

Generic pravastatin remains competitively priced, providing an affordable option in emerging markets where cost is a primary factor. Consequently, the branded product must differentiate itself through superior safety, tolerability, or added value to maintain market share.

Pricing and Reimbursement

Reimbursement policies significantly influence ALTOPREV’s market penetration. In developed markets, reimbursement is often aligned with clinical guidelines and comparative effectiveness. The entry of generics has driven down branded drug prices, compelling companies to adopt competitive pricing strategies or focus on patient adherence programs.

In developing markets, government health schemes and national formularies dictate pricing, often favoring generics, limiting profitability for branded drugs like ALTOPREV and pressuring margins.

Technological and Formulation Advances

Recent innovations focus on fixed-dose combinations, novel delivery mechanisms, and personalized medicine approaches to enhance efficacy and adherence. While ALTOPREV's traditional oral formulation remains standard, potential future formulations or combination pills could influence its market share.

Pharmacogenomics may also play a role; identifying patient subgroups who respond favorably to pravastatin can promote targeted use, maintaining niche demand.

Financial Trajectory Forecast

Short-term Outlook (1-3 Years)

The immediate future for ALTOPREV is characterized by declining revenues due to patent expiry and aggressive competition from generics. Price erosion is expected to be substantial—up to 60% in mature markets—reducing per-unit profitability. Nonetheless, core markets with high cardiovascular disease burdens, such as Asia-Pacific, Latin America, and parts of Eastern Europe, continue to sustain moderate demand owing to cost sensitivities and limited access to newer, expensive therapies.

Medium-term Outlook (4-7 Years)

Innovation-driven demand shifts will play a pivotal role. If the manufacturer leverages differentiation—such as quality-of-life improvements, adherence programs, or combination therapies—revenues can stabilize. Additionally, expanding into emerging markets with increasing healthcare access will provide some buffer against patent-related declines.

Potential acquisition or licensing agreements for novel formulations or companion diagnostics may also create new revenue streams. For example, developing biosimilar versions or integrating pharmacogenomic testing could open up premium segments.

Long-term Outlook (8+ Years)

In the long run, the landscape is likely dominated by low-cost generics, biosimilars, and competing novel agents with superior lipid-lowering efficacy. ALTOPREV's role may shift to specific niches—such as patients intolerant to potent statins—or be repositioned as part of combination regimens.

Market consolidation, patent expiration, and technological advancements will continue to exert downward pressure on prices. However, a strategic focus on value-added services, geographic diversification, and lifecycle management can sustain profitability.

Strategic Recommendations

• Innovation and Differentiation: Invest in formulation improvements, such as fixed-dose combinations, or explore adjunctive therapeutic options.
• Market Expansion: Enhance outreach in emerging markets where healthcare budgets favor affordable branded options.
• Lifecycle Management: Pursue patent extensions, if applicable, or develop new indications to prolong market exclusivity.
• Cost Optimization: Streamline manufacturing and supply chain processes to sustain margins amid price competition.
• Partnerships: Form alliances with local firms or tech companies to improve patient adherence and generate data for targeted therapies.

Key Takeaways

• ALTOPREV’s market is confronting a typical patent cliff, facing increased generic competition after patent expiry.
• Long-term growth hinges on strategic differentiation, market expansion, and innovation in drug delivery or combination therapies.
• Emerging markets present significant opportunities, given the continued prevalence of cardiovascular diseases and cost sensitivities.
• Reimbursement landscapes are evolving toward value-based care, demanding clear demonstrable benefits over cheaper alternatives.
• Companies must preemptively adapt by investing in lifecycle management, technological innovations, and strategic partnerships to sustain revenue streams.

FAQs

1. When did ALTOPREV (pravastatin sodium) lose its patent protection?
Patent protection for pravastatin in many jurisdictions expired between 2016 and 2018, leading to increased generic competition globally.

2. How does ALTOPREV compare with other statins in terms of efficacy and safety?
ALTOPREV (pravastatin) exhibits a favorable safety profile with fewer drug interactions; however, it is generally less potent in LDL-C lowering compared to atorvastatin and rosuvastatin, limiting its use in high-intensity settings.

3. What are the emerging market opportunities for ALTOPREV?
Expanding into Asia-Pacific, Latin America, and Eastern Europe remains promising due to rising cardiovascular disease burden and affordability considerations favoring branded generics.

4. How might technological advancements affect ALTOPREV’s future?
Innovations like fixed-dose combination drugs, personalized medicine, and digital adherence tools can enhance its relevance and help retain market share amid fierce competition.

5. What strategies can pharmaceutical companies implement to prolong ALTOPREV’s lifecycle?
Implementing lifecycle management through formulation enhancements, pursuing new indications, licensing novel technologies, and forming strategic partnerships are vital for sustained profitability.

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References

1. MarketWatch. "Global Statin Market Report 2022-2030."
2. World Health Organization. "Cardiovascular Diseases Fact Sheet."
3. IMS Health Data. "Trends in Statin Prescriptions 2015-2022."
4. FDA. "Regulatory Approvals and Patent Data for Pravastatin."
5. GlobalData Healthcare. "Emerging Markets and Lipid-Lowering Drugs."