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Last Updated: March 28, 2025

PREVALITE Drug Patent Profile


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

Prevalite is a drug marketed by Upsher Smith Labs and is included in one NDA.

The generic ingredient in PREVALITE is cholestyramine. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prevalite

A generic version of PREVALITE was approved as cholestyramine by EPIC PHARMA LLC on August 15th, 1996.

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Summary for PREVALITE
Drug patent expirations by year for PREVALITE
Drug Prices for PREVALITE

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Drug Sales Revenue Trends for PREVALITE

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Pharmacology for PREVALITE
Drug ClassBile Acid Sequestrant
Mechanism of ActionBile-acid Binding Activity

US Patents and Regulatory Information for PREVALITE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Upsher Smith Labs PREVALITE cholestyramine POWDER;ORAL 073263-001 Feb 22, 1996 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Upsher Smith Labs PREVALITE cholestyramine POWDER;ORAL 073263-002 Oct 30, 1997 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

Market Dynamics and Financial Trajectory for Prevalite (Cholestyramine)

Overview of Prevalite

Prevalite, also known as cholestyramine, is a bile acid sequestrant used primarily to treat hyperlipoproteinemia, including elevated levels of low-density lipoprotein (LDL) and very-low-density lipoprotein (VLDL) cholesterol. It belongs to the class of bile acid binding resins and is widely prescribed for managing hyperlipidemia and related cardiovascular conditions.

Market Size and Growth

The bile acid sequestrants market, which includes Prevalite, is projected to experience significant growth. By 2036, the market size is expected to reach USD 31 billion, growing at a Compound Annual Growth Rate (CAGR) of 8% during the forecast period from 2024 to 2036. In 2023, the market size was over USD 19 billion[1].

Key Drivers of Market Growth

Increasing Prevalence of Hyperlipidemia

The global increase in hyperlipidemia cases is a major driver for the bile acid sequestrants market. Between 2017 and 2020, approximately 10% of adults worldwide had hyperlipidemia with cholesterol levels above 240 mg/dL, and about 17% had low levels of high-density lipoprotein (HDL) cholesterol below 40 mg/dL[1].

Demand in Hospital Pharmacies

Hospital pharmacies are expected to hold the highest share of the bile acid sequestrants market by 2036, accounting for about 38% of the market. This is due to the critical role hospital pharmacies play in providing specific care and therapy, especially for patients with severe heart conditions. These pharmacies offer a broader selection of medications and customized dose guidelines, enhancing patient outcomes[1].

Technological Advancements and Novel Medications

Technological developments in drug delivery methods and the creation of new medications are expected to present profitable growth opportunities for market players, particularly in regions like Europe where there is a substantial patient base with cardiovascular disorders[1].

Market Segmentation

By Type

Prevalite is one of the key types of bile acid sequestrants, along with Colestid (colestipol) and Welchol (colesevelam). These drugs are differentiated based on their active ingredients and formulations[4].

By Distribution Channel

Hospital pharmacies are the primary distribution channel for bile acid sequestrants, followed by retail pharmacies and online platforms. The dominance of hospital pharmacies is attributed to the specialized care and therapy they provide[1].

Financial Aspects

Pricing

The cost of Prevalite can vary depending on the pharmacy and the quantity purchased. For example, a supply of 42 sugar-free 4 g/5.5 g oral powder for reconstitution can cost around $66. Generic versions of cholestyramine are also available, with prices ranging from $90.76 for 60 powder for reconstitution[2].

Revenue Growth

The cholestyramine market, which includes Prevalite, has shown steady revenue growth. From USD 186.60 million in 2023, the market size is expected to increase to USD 196.08 million in 2024[5].

Challenges and Restraints

Patient Inertia and Demand Patterns

Patient inertia and history-dependent demand can significantly impact the pricing dynamics of prescription drugs, including bile acid sequestrants. Patients tend to stick with familiar drugs, which can affect the adoption of generic or new medications. This inertia can lead to higher prices due to the reluctance to switch to more cost-effective alternatives[3].

Regulatory and Competitive Environment

The market for bile acid sequestrants is subject to regulatory scrutiny and competitive pressures. The presence of other dyslipidemia drugs, such as statins, fibrates, and combination therapies, can influence market share and pricing strategies[4].

Geographic Distribution

Regional Market Dynamics

The bile acid sequestrants market is expected to grow substantially in Europe due to the increasing prevalence of type 2 diabetes and cardiovascular disorders in the region. Europe's aging population and the higher incidence of diabetes among older adults contribute to the demand for potent drug treatments[1].

Global Market Landscape

The global dyslipidemia drugs market, including bile acid sequestrants, is segmented into regions such as North America, Europe, Asia Pacific, Latin America, and the Rest of the World. Each region has its unique market drivers, restraints, and opportunities, influenced by local healthcare policies, patient demographics, and economic factors[4].

Pipeline and Future Developments

Ongoing Research and Clinical Trials

There are ongoing clinical trials and research studies focused on understanding the effects of bile acid sequestrants on other chronic diseases. For example, recent clinical trials sponsored by companies like Eli Lilly and Company and Loxo Oncology, Inc. are exploring new applications and formulations of cholestyramine[5].

Technological Innovations

Advancements in drug delivery methods and the development of novel medications are expected to drive future growth in the bile acid sequestrants market. These innovations can improve patient compliance and outcomes, thereby expanding the market share of drugs like Prevalite[1].

Key Takeaways

  • The bile acid sequestrants market, including Prevalite, is projected to reach USD 31 billion by 2036, growing at a CAGR of 8%.
  • Hospital pharmacies will dominate the market due to their critical role in patient care.
  • Technological advancements and the creation of new medications will drive market growth.
  • Patient inertia and history-dependent demand can impact pricing dynamics.
  • The market is segmented by type, distribution channel, and geographic region.

FAQs

What is Prevalite used for?

Prevalite, or cholestyramine, is used to treat hyperlipoproteinemia, including elevated levels of LDL and VLDL cholesterol.

How much does Prevalite cost?

The cost of Prevalite can vary, but a supply of 42 sugar-free 4 g/5.5 g oral powder for reconstitution can cost around $66.

What are the key drivers of the bile acid sequestrants market?

Key drivers include the increasing prevalence of hyperlipidemia, demand in hospital pharmacies, and technological advancements in drug delivery methods.

Which region is expected to see substantial growth in the bile acid sequestrants market?

Europe is expected to see substantial growth due to the increasing prevalence of type 2 diabetes and cardiovascular disorders.

Are there generic versions of Prevalite available?

Yes, generic versions of cholestyramine are available, with prices ranging from $90.76 for 60 powder for reconstitution.

Sources

  1. Research Nester, "Bile Acid Sequestrants Market Size & Share | Growth Report 2036"
  2. Drugs.com, "Prevalite Prices, Coupons, Copay Cards & Patient Assistance"
  3. Harvard Scholar, "Explaining Prescription Drug Pricing Dynamics"
  4. iHealthcare Analyst, "Dyslipidemia Drugs Market and Forecast 2024-2031"
  5. Drug Patent Watch, "Generic CHOLESTYRAMINE INN equivalents, drug patent expiry"

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