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Last Updated: December 26, 2024

PRAVASTATIN SODIUM Drug Patent Profile


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When do Pravastatin Sodium patents expire, and what generic alternatives are available?

Pravastatin Sodium is a drug marketed by 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 eighteen NDAs.

The generic ingredient in PRAVASTATIN SODIUM 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 Pravastatin Sodium

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

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Drug patent expirations by year for PRAVASTATIN SODIUM
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Recent Clinical Trials for PRAVASTATIN SODIUM

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SponsorPhase
University of Maryland, BaltimorePhase 4
University of ThessalyN/A
University of Southern CaliforniaPhase 2

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Pharmacology for PRAVASTATIN SODIUM
Medical Subject Heading (MeSH) Categories for PRAVASTATIN SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for PRAVASTATIN SODIUM
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
Norvium Bioscience PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 079187-001 May 27, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Inc PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076714-004 Dec 28, 2007 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pliva Hrvatska Doo PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077730-002 Nov 21, 2006 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076939-004 Oct 23, 2006 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 079187-003 May 27, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pliva Hrvatska Doo PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077730-003 Nov 21, 2006 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

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