Lovastatin - Generic Drug Details

What are the generic drug sources for lovastatin and what is the scope of patent protection?

Lovastatin is the generic ingredient in three branded drugs marketed by Covis, Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Chartwell Rx, Corepharma, Epic Pharma Llc, Lupin, Sun Pharm Industries, Teva, and Merck, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-three drug master file entries for lovastatin. Twenty-three suppliers are listed for this compound.

Summary for lovastatin

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	12
Drug Master File Entries:	33
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	76
Patent Applications:	7,114
Drug Prices:	Drug price trends for lovastatin
Drug Sales Revenues:	Drug sales revenues for lovastatin
What excipients (inactive ingredients) are in lovastatin?	lovastatin excipients list
DailyMed Link:	lovastatin at DailyMed

See drug prices for lovastatin

See drug sales revenues for lovastatin

Recent Clinical Trials for lovastatin

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

Sponsor	Phase
Assiut University	N/A
Heart Health Research Center	Phase 4
AstraZeneca	Phase 4

See all lovastatin clinical trials

Pharmacology for lovastatin

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for lovastatin

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for lovastatin

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for lovastatin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Elizabeth	LOVASTATIN	lovastatin	TABLET;ORAL	075828-002	Dec 17, 2001	AB	RX	No	No
Aurobindo Pharma Usa	LOVASTATIN	lovastatin	TABLET;ORAL	075935-003	Dec 17, 2001		DISCN	No	No
Chartwell Rx	LOVASTATIN	lovastatin	TABLET;ORAL	075300-003	Dec 17, 2001	AB	RX	No	No
Teva	LOVASTATIN	lovastatin	TABLET;ORAL	075551-002	Dec 17, 2001	AB	RX	No	No

Expired US Patents for lovastatin

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	021316-001	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

Lovastatin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Lovastatin

Introduction to Lovastatin

Lovastatin, a member of the statin class of drugs, is widely used for managing hypercholesterolemia and reducing the risk of cardiovascular diseases. Its market dynamics are influenced by several factors, including healthcare infrastructure, regulatory environments, and demographic changes.

Global Market Size and Growth

The global Lovastatin market is experiencing significant growth. As of 2023, the market size was valued at USD 1.5 billion and is projected to reach USD 2 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4% from 2024 to 2031[3].

Regional Market Analysis

North America

North America dominates the Lovastatin market, holding a substantial 38% market share. The region's robust healthcare infrastructure and high incidence of cardiovascular diseases contribute to the widespread use of Lovastatin. Stringent healthcare regulations and a proactive approach to disease prevention further drive the market in this region[1].

Europe

Europe is another significant market for Lovastatin, with a 30% market share. The region's healthcare infrastructure and increasing awareness of cardiovascular health are key drivers. The demand for cholesterol-lowering medications is rising due to lifestyle changes and an aging population[1].

Asia Pacific

The Asia Pacific region is the fastest-growing market for Lovastatin, holding a 23% market share. The growth is fueled by increasing awareness of cardiovascular health, rising prevalence of hypercholesterolemia, and lifestyle changes. Economic development and improved healthcare access in the region are also driving the adoption of preventive medications like Lovastatin[1].

Middle East and Africa

The Middle East and Africa (MEA) region is emerging as a notable player, exhibiting a robust growth rate of 4.00%. The region's pharmaceutical landscape is witnessing an upsurge in cardiovascular health awareness, with a growing demand for cholesterol-lowering medications[1].

Market Segmentation

By Type

The Lovastatin market is segmented into Extended-Release (ER) Tablets and conventional Tablets. The ER Tablet segment is expected to register the highest CAGR due to growing demand for these formulations, which offer improved patient compliance and therapeutic efficacy[4].

By Application

The market is segmented into applications such as Hyperlipidemia Treatment, Cardiovascular Disease Management, and Cholesterol Reduction. Hospitals are the largest revenue contributors in the application segment, followed by drug stores and other healthcare facilities[4].

Drivers of Market Growth

Increasing Awareness of Heart Health

The growing awareness of heart health and the incidence of hypercholesterolemia are significant drivers of the Lovastatin market. As more people become aware of the importance of cholesterol management, the demand for statins like Lovastatin increases[3].

Aging Population and Lifestyle Changes

The aging population and rising rates of lifestyle-related disorders, such as obesity and diabetes, contribute to the market's growth. These factors increase the risk of cardiovascular diseases, making Lovastatin a crucial medication for preventive care[3].

Generic Versions and Pharmaceutical Advancements

The availability of generic versions of Lovastatin and advancements in pharmaceutical research have increased the drug's affordability and accessibility. This has expanded the market reach, especially in regions with improving healthcare access[3].

Cost-Effectiveness and Economic Evaluation

Cost-Effectiveness Ratios

Studies have shown that the cost-effectiveness of Lovastatin varies with dosage and patient risk profile. For example, the average cost-effectiveness of Lovastatin at 20 mg/day ranges from $11,040 to $52,463 per year of life saved for men and women. However, increasing the dosage to 80 mg/day significantly increases the cost, making it less cost-effective for low-risk patients[2].

Lifetime Therapy Benefits

An economic evaluation using lifetime Lovastatin therapy as the intervention model for adults between 35 and 55 years of age showed that the cost per life-year saved ranged from $9,000 to $106,000 for average-risk men and $35,000 to $297,000 for average-risk women. These figures indicate that Lovastatin can be a cost-effective intervention for high-risk individuals[5].

Financial Trajectory

Market Size Projections

The Lovastatin market is expected to grow significantly, with the global market size anticipated to reach USD 2 billion by 2031. This growth is driven by the increasing demand for cholesterol-lowering medications and the expanding reach of preventive healthcare services[3].

Regional Market Projections

North America is expected to maintain its dominant position, while the Asia Pacific region is projected to be the fastest-growing market. Europe and the MEA region will also continue to contribute significantly to the global market size[1].

Key Players and Competitive Landscape

The Lovastatin market is competitive, with key players including Covis Pharma, TEVA, MYLAN, LUPIN, APOTEX, and Sun Pharmaceutical. These companies are focusing on strategic collaborations, product advancements, and expanding their market presence through generic versions and improved formulations[4].

Key Takeaways

• The global Lovastatin market is growing at a CAGR of 4% from 2024 to 2031.
• North America and Europe are significant markets, while the Asia Pacific region is the fastest-growing.
• Increasing awareness of heart health, an aging population, and lifestyle changes drive market growth.
• The availability of generic versions and pharmaceutical advancements enhance market accessibility.
• Lovastatin is cost-effective for high-risk individuals but becomes less so at higher dosages.

FAQs

1. What is the current market size of Lovastatin, and what is its projected growth?

The Lovastatin market was valued at USD 1.5 billion in 2023 and is expected to reach USD 2 billion by 2031, growing at a CAGR of 4% from 2024 to 2031[3].

2. Which region dominates the Lovastatin market?

North America dominates the Lovastatin market, holding a significant 38% market share[1].

3. What are the key drivers of the Lovastatin market?

Key drivers include increasing awareness of heart health, an aging population, lifestyle changes, and the availability of generic versions and pharmaceutical advancements[3].

4. How cost-effective is Lovastatin?

Lovastatin is cost-effective for high-risk individuals, with cost-effectiveness ratios ranging from $9,000 to $106,000 per life-year saved. However, it becomes less cost-effective at higher dosages[2][5].

5. Who are the major players in the Lovastatin market?

Major players include Covis Pharma, TEVA, MYLAN, LUPIN, APOTEX, and Sun Pharmaceutical[4].

Cited Sources:

1. Cognitive Market Research - Lovastatin Market Report
2. JAMA Network - Treating Hyperlipidemia for the Primary Prevention of Coronary
3. Market Research Intellect - Lovastatin Market Size and Industry Growth | Forecast 2031
4. Verified Market Research - Lovastatin Market Size, Share, Trends, Opportunities & Forecast
5. PubMed - An economic evaluation of lovastatin for cholesterol lowering and primary prevention of coronary artery disease