PRAVACHOL Drug Patent Profile

When do Pravachol patents expire, and when can generic versions of Pravachol launch?

Pravachol is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in PRAVACHOL is pravastatin sodium. There are sixteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pravachol

A generic version of PRAVACHOL was approved as pravastatin sodium by TEVA on April 24^th, 2006.

Summary for PRAVACHOL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	28
Patent Applications:	6,760
Drug Prices:	Drug price information for PRAVACHOL
Drug Sales Revenues:	Drug sales revenues for PRAVACHOL
What excipients (inactive ingredients) are in PRAVACHOL?	PRAVACHOL excipients list
DailyMed Link:	PRAVACHOL at DailyMed

See drug prices for PRAVACHOL

See drug sales revenues for PRAVACHOL

Recent Clinical Trials for PRAVACHOL

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

Sponsor	Phase
Amgen	Phase 4
Brigham and Women's Hospital	Phase 4
Mayo Clinic	Phase 2

See all PRAVACHOL clinical trials

Paragraph IV (Patent) Challenges for PRAVACHOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRAVACHOL	Tablets	pravastatin sodium	30 mg	019898	1	2005-06-01

US Patents and Regulatory Information for PRAVACHOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-002	Oct 31, 1991		DISCN	Yes	No
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-008	Dec 18, 2001		DISCN	Yes	No
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-003	Oct 31, 1991		DISCN	Yes	No
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-004	Mar 22, 1993		DISCN	Yes	No

Expired US Patents for PRAVACHOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-003	Oct 31, 1991	5,180,589*PED
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-008	Dec 18, 2001	5,622,985*PED
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-002	Oct 31, 1991	4,346,227*PED
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-004	Mar 22, 1993	5,180,589*PED
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-004	Mar 22, 1993	5,030,447*PED
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-008	Dec 18, 2001	5,180,589*PED

International Patents for PRAVACHOL

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

Country	Patent Number	Title	Estimated Expiration
Denmark	149080
China	1026861
Japan	H04243839	DRUG CONTAINING HMG COA REDUCTASE INHIBITOR
Japan	S57108039	ML-236B DERIVATIVE
South Africa	8901424
Ireland	890929

PRAVACHOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pravachol (Pravastatin)

Market Overview

Pravachol, known generically as pravastatin, is a statin medication used to lower LDL (bad) cholesterol and triglycerides, and to increase HDL (good) cholesterol. The global pravastatin market is experiencing significant growth driven by several key factors.

Growth Drivers

Increasing Prevalence of Cardiovascular Diseases

The rising prevalence of cardiovascular diseases, obesity, and diabetes is a major driver for the pravastatin market. These conditions are often associated with high levels of LDL cholesterol, which pravastatin helps to reduce. According to recent studies, the increasing sedentary lifestyle and urbanization are leading to higher rates of cholesterol-related disorders, thereby increasing the demand for statins like pravastatin[3][4].

High Healthcare Spending

Regions with high healthcare spending, such as North America, particularly the US and Canada, are significant contributors to the market growth. The US spends approximately 17.7% of its GDP on healthcare, and Canada spends around 15.2%, which supports the demand for effective cholesterol treatments[1].

Regulatory Guidelines and Recommendations

Guidelines from medical organizations like the American College of Cardiology and the American Heart Association recommend statin therapy for individuals with a high risk of heart attacks, further boosting the demand for pravastatin[3].

Market Segmentation

By Dosage Type

The pravastatin market is segmented by dosage types, including 10 mg, 20 mg, 40 mg, and 80 mg tablets. Each dosage type has a specific market share and regional distribution, with the North American region being a major consumer due to the high prevalence of LDL cholesterol among American adults[1].

By End User

The market is also segmented by end users, including children and adults. However, due to side effects and allergic reactions, pravastatin is less prescribed to children and adults over 65 years old[1].

By Region

Geographically, the market is segmented into North America, Europe, Asia-Pacific, and the Rest of the World. North America holds the major share due to high healthcare spending and a large patient base suffering from cardiovascular diseases[1][3].

Financial Trajectory

Market Size and Growth Rate

The global pravastatin market is anticipated to grow at a considerable CAGR of 5.4% during the forecast period. This growth is driven by the increasing demand for statins as an evidence-based treatment for lifestyle-related diseases[1].

Revenue Impact

The market experienced a significant decline in revenue during the COVID-19 pandemic due to postponed diagnoses and treatments. However, as the situation normalized, the market rebounded to its pre-pandemic levels. The North American region, particularly the US and Canada, continues to contribute substantially to the market revenue due to high healthcare spending and a large patient base[1].

Key Players and Strategies

Major companies such as Bristol-Myers Squibb, Novartis International AG, Glenmark Pharmaceuticals Ltd., Dr. Reddy's Laboratories, and others are driving market growth through strategies like mergers and acquisitions, collaborations, funding, and new product launches. These strategies help these companies stay competitive and expand their market share[1].

Challenges and Limitations

Side Effects and Allergic Reactions

Despite the growth drivers, the market faces challenges such as side effects and allergic reactions associated with pravastatin, particularly in children and older adults. This limits the prescription of the drug in these age groups[1].

Cultural and Commercial Factors

Cultural and commercial factors, including the availability of alternative treatments and the perception of statins, can also hamper market growth. Additionally, the requirement for adequate remedy options and the presence of generic alternatives can impact the market dynamics[3].

Regional Analysis

North America

North America, particularly the US and Canada, holds a dominant position in the global pravastatin market. The high prevalence of LDL cholesterol among American adults and the significant healthcare spending in these countries drive the market growth in this region[1][3].

Europe and Asia-Pacific

Europe and the Asia-Pacific region also contribute to the market growth, although to a lesser extent compared to North America. The increasing awareness of cholesterol-related disorders and the adoption of technologically advanced healthcare facilities in these regions support the demand for pravastatin[1][3].

Cost and Pricing

Prescription Drug Costs

The cost of prescription drugs, including pravastatin, is a significant concern. Public programs like Medicaid often bear the brunt of high prescription drug costs, which can be a major economic burden. Strategies to promote drug pricing transparency and value-based drug purchasing approaches are being explored to manage these costs[2].

Impact of Generic Alternatives

The introduction of generic alternatives has a significant impact on the market. The "patent cliff" period, during which major blockbuster drugs lose their patent protection, allows generic drugs to enter the market, affecting the revenue of branded drugs like pravastatin[2].

Research and Development

High-Dose Potent Statin Therapy

Research and development in the field of statins continue to drive market growth. Studies have led to the adoption of high-dose potent statin therapy in combination with other drugs for the treatment of conditions like heterozygous familial hypercholesterolemia (heFH)[4].

Technological Advancements

Technological advancements in healthcare facilities and the increasing awareness of cholesterol-related disorders through campaigns also contribute to the sustained demand for pravastatin[3].

Key Takeaways

• The global pravastatin market is growing at a CAGR of 5.4% driven by the increasing demand for statins to treat lifestyle-related diseases.
• North America holds the major share in the market due to high healthcare spending and a large patient base.
• The market faces challenges such as side effects and the availability of generic alternatives.
• Research and development, particularly in high-dose potent statin therapy, continue to support market growth.
• Strategies to manage prescription drug costs, such as drug pricing transparency and value-based purchasing, are crucial for market sustainability.

FAQs

Q: What is the primary use of Pravachol (pravastatin)?

A: Pravachol (pravastatin) is used to lower LDL (bad) cholesterol and triglycerides, and to increase HDL (good) cholesterol.

Q: Which region dominates the global pravastatin market?

A: North America, particularly the US and Canada, holds the dominant position in the global pravastatin market.

Q: What are the key drivers of the pravastatin market?

A: The key drivers include the rising prevalence of cardiovascular diseases, high healthcare spending, and regulatory guidelines recommending statin therapy.

Q: How has the COVID-19 pandemic affected the pravastatin market?

A: The market experienced a decline in revenue during the pandemic but rebounded as the situation normalized.

Q: What are the challenges faced by the pravastatin market?

A: The market faces challenges such as side effects, allergic reactions, and the availability of generic alternatives.

Sources

1. OMR Global: Pravastatin Market 2022 Size, Growth Analysis Report, Forecast to ...
2. Washington State Health Care Authority: Review of Prescription Drug Costs and Summary of Potential Strategies
3. Maximize Market Research: Statin Market: Global Industry Analysis and Forecast (2024-2030)
4. IMARC Group: Pravastatin (Pravachol) Manufacturing Plant Project Report 2024