PRAVASTATIN SODIUM - Generic Drug Details

What are the generic drug sources for pravastatin sodium and what is the scope of freedom to operate?

Pravastatin sodium is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Accord Hlthcare, Apnar Pharma Lp, Apotex, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Cipla, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hisun Pharm Hangzhou, Norvium Bioscience, Pliva Hrvatska Doo, Ranbaxy Labs Ltd, Teva, Teva Pharms, Watson Labs, and Zydus Pharms Usa, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for pravastatin sodium. Forty suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for PRAVASTATIN SODIUM

US Patents:	0
Tradenames:	2
Applicants:	18
NDAs:	19
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	30
Patent Applications:	7,311
Drug Prices:	Drug price trends for PRAVASTATIN SODIUM
Drug Sales Revenues:	Drug sales revenues for PRAVASTATIN SODIUM
What excipients (inactive ingredients) are in PRAVASTATIN SODIUM?	PRAVASTATIN SODIUM excipients list
DailyMed Link:	PRAVASTATIN SODIUM at DailyMed

See drug prices for PRAVASTATIN SODIUM

See drug sales revenues for PRAVASTATIN SODIUM

Recent Clinical Trials for PRAVASTATIN SODIUM

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

Sponsor	Phase
University of Maryland, Baltimore	Phase 4
University of Thessaly	N/A
University of Southern California	Phase 2

See all PRAVASTATIN SODIUM clinical trials

Generic filers with tentative approvals for PRAVASTATIN SODIUM

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET;ORAL
		40MG	TABLET;ORAL
		20MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for PRAVASTATIN SODIUM

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

Medical Subject Heading (MeSH) Categories for PRAVASTATIN SODIUM

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PRAVASTATIN SODIUM

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

Paragraph IV (Patent) Challenges for PRAVASTATIN SODIUM

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 PRAVASTATIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	076341-003	Oct 23, 2006	AB	RX	No	No
Zydus Pharms Usa	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	077751-004	Apr 30, 2008	AB	RX	No	No
Watson Labs	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	076939-003	Oct 23, 2006	AB	RX	No	No
Zydus Pharms Usa	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	077751-002	Apr 30, 2008	AB	RX	No	No
Apotex	PRAVASTATIN SODIUM	pravastatin sodium	TABLET;ORAL	076341-002	Oct 23, 2006	AB	RX	No	No
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-008	Dec 18, 2001		DISCN	Yes	No

Expired US Patents for PRAVASTATIN SODIUM

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

PRAVASTATIN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pravastatin Sodium

Introduction to Pravastatin Sodium

Pravastatin sodium is an FDA-approved HMG Co-A reductase inhibitor, commonly used to manage and treat primary hypercholesterolemia, hyperlipidemia, and mixed dyslipidemia. It is also indicated for the prevention of cardiovascular events in patients with coronary artery disease[5].

Market Size and Growth Projections

The global Pravastatin Sodium market has been experiencing rapid and substantial growth. As of 2023, the market was valued at a significant figure, and it is anticipated to continue its robust growth from 2023 to 2031. The market is projected to expand significantly, driven by favorable market dynamics and increasing demand for statins due to lifestyle-related diseases[1][4].

Segmentation and Regional Analysis

The Pravastatin Sodium market is segmented based on type (above 99.0% purity and below 99.0% purity) and application (blood lipids and other). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa.

• North America: This region is expected to maintain its dominant position during the forecast period, driven by the high prevalence of cardiovascular disorders and the presence of prominent healthcare service providers[3][4].
• Asia-Pacific: This region is also anticipated to see significant growth, driven by the increasing demand for statins due to rising urbanization and lifestyle changes[4].

Key Drivers and Opportunities

Increasing Prevalence of Cardiovascular Diseases

The rising prevalence of cardiovascular diseases, partly due to sedentary lifestyles and changing dietary habits, is a major driver for the Pravastatin Sodium market. Statins, including pravastatin, are widely prescribed to lower LDL cholesterol and reduce the risk of heart attacks and strokes[3].

Cholesterol Awareness and Healthcare Advancements

Cholesterol awareness campaigns and advancements in healthcare facilities are increasing the demand for statins. The American College of Cardiology and the American Heart Association's guidelines recommending statins for individuals with a high risk of heart attacks further boost the market[3].

Cost-Effectiveness

Studies have shown that replacing other statins like lovastatin with pravastatin can result in significant cost reductions without compromising the efficacy in lowering serum lipid concentrations. This cost-effectiveness is another driving factor for the market[2].

Challenges and Restraints

Side Effects and Safety Concerns

Despite its benefits, pravastatin is associated with several adverse effects, including nausea, dizziness, arthralgia, and potentially serious effects like hepatitis and renal impairment. These side effects can limit the market growth[5].

Cultural and Commercial Factors

Cultural perceptions and commercial factors, such as the availability of alternative treatments and the presence of generic options, can also hamper the growth of the Pravastatin Sodium market[3].

Competitive Landscape

The global Pravastatin Sodium market is competitive, with several major manufacturers such as Teva API, Zhejiang Hisun Pharmaceutical, Apotex Pharmachem, Concord Biotech, Biocon, Chunghwa Chemical Synthesis & Biotech, and Livzon New North River Pharmaceutical. These companies play a significant role in shaping the market through their product offerings and market strategies[4].

Financial Trajectory

Revenue Projections

The global Pravastatin Sodium market is expected to witness significant revenue growth. The market size is projected to increase substantially from 2023 to 2030, with a notable CAGR during the forecast period[1][4].

Cost Savings

The cost reduction associated with the use of pravastatin compared to other statins is a financial advantage. For instance, a study showed a 21% cost reduction when lovastatin was replaced with pravastatin, without any significant change in serum lipid concentrations[2].

Technological Trends and New Product Developments

The market is also influenced by technological trends and new product developments. The integration of advanced healthcare technologies and the development of new formulations or combinations of statins are expected to further drive the market growth[4].

Regional Market Sizes

• North America: Expected to increase from a significant figure in 2023 to a higher figure by 2030, at a CAGR during the forecast period[4].
• Asia-Pacific: Also anticipated to grow significantly, driven by the increasing demand for statins in this region[4].

Key Companies and Market Ranks

The report provides detailed profiles of the competitive landscape, key competitors, and their respective market ranks. This information is crucial for manufacturers, new entrants, and industry chain-related companies to develop business and growth strategies[4].

Conclusion

The Pravastatin Sodium market is poised for robust growth driven by increasing demand for statins, cost-effectiveness, and advancements in healthcare. However, it also faces challenges such as side effects and cultural-commercial factors. Understanding these market dynamics is essential for stakeholders to make informed business decisions.

Key Takeaways

• Rapid Market Growth: The Pravastatin Sodium market is expected to grow significantly from 2023 to 2031.
• Cost-Effectiveness: Pravastatin offers cost savings compared to other statins without compromising efficacy.
• Increasing Demand: Rising prevalence of cardiovascular diseases and lifestyle-related disorders drive the demand for statins.
• Competitive Landscape: The market is competitive with several major manufacturers influencing the market.
• Regional Growth: North America and Asia-Pacific are key regions driving the market growth.

FAQs

What is the primary use of Pravastatin Sodium?

Pravastatin Sodium is primarily used to manage and treat primary hypercholesterolemia, hyperlipidemia, and mixed dyslipidemia, as well as to prevent cardiovascular events in patients with coronary artery disease[5].

How does Pravastatin Sodium compare to other statins in terms of cost?

Pravastatin Sodium has been shown to offer a 21% cost reduction compared to lovastatin without any significant change in serum lipid concentrations[2].

What are the common adverse effects associated with Pravastatin Sodium?

Common adverse effects include nausea, dizziness, arthralgia, myalgia, headache, and others. Serious adverse effects may include hepatitis, renal impairment, and blurred vision[5].

Which regions are expected to drive the growth of the Pravastatin Sodium market?

North America and Asia-Pacific are expected to be the key regions driving the market growth due to the high prevalence of cardiovascular diseases and lifestyle-related disorders[3][4].

Who are the major manufacturers in the Pravastatin Sodium market?

Major manufacturers include Teva API, Zhejiang Hisun Pharmaceutical, Apotex Pharmachem, Concord Biotech, Biocon, Chunghwa Chemical Synthesis & Biotech, and Livzon New North River Pharmaceutical[4].

Cited Sources

1. Market Research Intellect: Global Pravastatin Sodium Market Size, Scope And Forecast Report.
2. PubMed: Replacing lovastatin with pravastatin: effect on serum lipids and costs.
3. Maximize Market Research: Statin Market: Global Industry Analysis and Forecast (2024-2030).
4. OpenPR: Pravastatin Sodium Market Analysis (2024-2030): Key Trends, Growth Drivers, and Forecast.
5. NCBI Bookshelf: Pravastatin - StatPearls.