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-three 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	126
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

Pharmacology for ALTOPREV

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

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		RX	Yes	Yes
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-002	Jun 26, 2002		RX	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	021316-001	Jun 26, 2002
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-004	Jun 26, 2002

International Patents for ALTOPREV

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

Country	Patent Number	Title	Estimated Expiration
Australia	737962
Germany	20023538
Spain	2252872

ALTOPREV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ALTOPREV (Lovastatin)

Introduction to ALTOPREV

ALTOPREV, also known as lovastatin, is a statin medication used to lower cholesterol levels and reduce the risk of cardiovascular diseases. It is indicated for the reduction of elevated total cholesterol, low-density lipoprotein cholesterol (LDL-C), and triglycerides, as well as for increasing high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia[3].

Market Demand and Drivers

The demand for statins, including ALTOPREV, is driven by several key factors:

• Increasing Prevalence of Cholesterol-Related Disorders: The rise in cholesterol levels due to changing lifestyles, particularly in developed regions, is a significant driver. Sedentary lifestyles and poor dietary habits contribute to high cholesterol, which is difficult to manage through diet and exercise alone, making statins a necessary treatment option[1].

• Cholesterol Awareness and Healthcare Advancements: Cholesterol awareness campaigns and advancements in healthcare facilities have increased the demand for statins. The rapid urbanization and associated lifestyle changes also contribute to the sustained demand for these medications[1].

• Cardiovascular Disease Prevalence: The high incidence of cardiovascular diseases, such as heart attacks and strokes, further drives the demand for statins. In the U.S., for example, one person dies every 36 seconds from cardiovascular disease, highlighting the critical need for effective cholesterol management[1].

Market Size and Growth

The global statin market, which includes ALTOPREV, was valued at $15.39 billion in 2023 and is expected to reach $18.93 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 3% during the forecast period[1].

Competitive Landscape

ALTOPREV is part of a competitive market with several other statin molecules such as simvastatin, pravastatin, and atorvastatin. Lovastatin, along with simvastatin and pravastatin, has significant annual sales, with these three statins collectively generating over $10 billion globally. However, lovastatin is already off-patent globally, which has led to the rise of generic versions and impacted the market dynamics[1].

Impact of Generic Versions

The introduction of generic statins has significantly altered the market landscape. After the end of market exclusivity for brand-name statins, the number of brand-name statin purchases decreased dramatically. For instance, the annual prescriptions of Crestor (a brand-name statin) dropped from 24.8 million in 2015 to 1.63 million in 2018, while generic rosuvastatin purchases surged to 22.5 million in 2018. This trend is expected to continue, affecting the financial trajectory of brand-name statins like ALTOPREV[4].

Financial Trajectory

• Revenue Decline: The transition to generic versions has led to a substantial decline in revenue for brand-name statins. For example, private insurance spending for Lipitor (another brand-name statin) fell from $4.72 billion to $0.01 billion over a few years following the end of market exclusivity. This trend is likely to affect ALTOPREV similarly, as generic lovastatin becomes more prevalent[4].

• Cost Savings: The shift to generic statins has resulted in significant cost savings for patients and healthcare systems. However, this shift also means that the revenue generated by brand-name statins like ALTOPREV will continue to decline as generic alternatives become more widely used.

• Market Share: Despite the decline in revenue, lovastatin remains a significant player in the statin market due to its efficacy and long-standing presence. However, its market share is expected to be eroded by generic competitors.

Clinical Efficacy and Indications

ALTOPREV has been shown to be highly effective in reducing LDL-C, total cholesterol, and triglycerides, while increasing HDL-C. Clinical studies have demonstrated dose-related reductions in LDL-C and total cholesterol, with mean reductions ranging from 23.8% to 40.8% depending on the dose[3].

Side Effects and Limitations

While ALTOPREV is generally well-tolerated, it can have side effects such as muscle pain and liver enzyme elevations. These side effects, along with cultural and commercial factors, can limit the market growth of statins[1].

Regional Market Analysis

The North American region, particularly the U.S., holds a dominant position in the statin market due to the high prevalence of cardiovascular disorders and the presence of prominent healthcare service providers. The American College of Cardiology and the American Heart Association guidelines recommending statins for individuals with a high risk of heart attack further support the demand in this region[1].

Key Takeaways

• Increasing Demand: The demand for statins, including ALTOPREV, is driven by the rising prevalence of cholesterol-related disorders and cardiovascular diseases.
• Generic Competition: The introduction of generic statins has significantly impacted the revenue of brand-name statins, leading to a decline in market share and revenue.
• Clinical Efficacy: ALTOPREV remains a clinically effective option for cholesterol management, despite the rise of generic alternatives.
• Regional Dominance: North America, particularly the U.S., continues to be a dominant market for statins due to high disease prevalence and robust healthcare infrastructure.

FAQs

1. What is ALTOPREV used for?

   • ALTOPREV (lovastatin) is used to reduce elevated total cholesterol, LDL-C, and triglycerides, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia[3].

2. How does ALTOPREV compare to other statins?

   • ALTOPREV is part of a competitive market with other statins like simvastatin, pravastatin, and atorvastatin. It has significant annual sales but faces competition from generic versions[1].

3. What is the impact of generic statins on ALTOPREV?

   • The introduction of generic statins has led to a decline in revenue for brand-name statins like ALTOPREV, as generic versions become more widely used and preferred due to cost savings[4].

4. What are the side effects of ALTOPREV?

   • Common side effects include muscle pain and liver enzyme elevations. These side effects can limit the market growth of statins[1].

5. Which region dominates the statin market?

   • The North American region, particularly the U.S., holds a dominant position in the statin market due to the high prevalence of cardiovascular disorders and robust healthcare infrastructure[1].

Sources

1. Maximize Market Research - Statin Market: Global Industry Analysis and Forecast (2024-2030)[1]
2. Palo Alto Networks - Palo Alto Networks Reports Fiscal Fourth Quarter and Fiscal Year 2024 Financial Results[2]
3. FDA - ALTOPREV® lovastatin extended-release tablets[3]
4. JAMA Network Open - Use and Expenditures for Brand-name Statins After Introduction of Generic Statins[4]