CHOLESTYRAMINE - Generic Drug Details

What are the generic drug sources for cholestyramine and what is the scope of patent protection?

Cholestyramine is the generic ingredient in eight branded drugs marketed by Parke Davis, Ajanta Pharma Ltd, Alkem Labs Ltd, Ani Pharms, Endo Operations, Epic Pharma Llc, Ivax Sub Teva Pharms, Tagi, Teva, Upsher Smith Labs, Zydus Pharms, Macleods Pharms Ltd, Teva Pharms, Chartwell Rx, Bristol Myers, and Apothecon, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for cholestyramine. Fourteen suppliers are listed for this compound.

Summary for CHOLESTYRAMINE

US Patents:	0
Tradenames:	8
Applicants:	16
NDAs:	26
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	39
Drug Prices:	Drug price trends for CHOLESTYRAMINE
What excipients (inactive ingredients) are in CHOLESTYRAMINE?	CHOLESTYRAMINE excipients list
DailyMed Link:	CHOLESTYRAMINE at DailyMed

See drug prices for CHOLESTYRAMINE

Recent Clinical Trials for CHOLESTYRAMINE

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

Sponsor	Phase
Centre Hospitalier Universitaire de Nice	N/A
Eli Lilly and Company	Phase 1
Loxo Oncology, Inc.	Phase 1

See all CHOLESTYRAMINE clinical trials

Pharmacology for CHOLESTYRAMINE

Drug Class	Bile Acid Sequestrant
Mechanism of Action	Bile-acid Binding Activity

US Patents and Regulatory Information for CHOLESTYRAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tagi	CHOLESTYRAMINE	cholestyramine	POWDER;ORAL	209597-001	Mar 9, 2021	AB	RX	No	No
Ivax Sub Teva Pharms	CHOLESTYRAMINE	cholestyramine	POWDER;ORAL	074771-002	Jul 9, 1997		DISCN	No	No
Ajanta Pharma Ltd	CHOLESTYRAMINE	cholestyramine	POWDER;ORAL	211119-002	Apr 6, 2020	AB	RX	No	No
Zydus Pharms	CHOLESTYRAMINE	cholestyramine	POWDER;ORAL	202901-001	Jul 2, 2018	AB	RX	No	No
Ivax Sub Teva Pharms	CHOLESTYRAMINE	cholestyramine	POWDER;ORAL	074771-001	Jul 9, 1997		DISCN	No	No
Upsher Smith Labs	PREVALITE	cholestyramine	POWDER;ORAL	073263-002	Oct 30, 1997	AB	RX	No	No
Epic Pharma Llc	CHOLESTYRAMINE LIGHT	cholestyramine	POWDER;ORAL	074558-001	Aug 15, 1996	AB	RX	No	Yes

Expired US Patents for CHOLESTYRAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Parke Davis	CHOLYBAR	cholestyramine	BAR, CHEWABLE;ORAL	071621-001	May 26, 1988
Parke Davis	CHOLYBAR	cholestyramine	BAR, CHEWABLE;ORAL	071739-001	May 26, 1988

CHOLESTYRAMINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cholestyramine

Introduction

Cholestyramine, a bile acid sequestrant, is a medication widely used to lower cholesterol levels and treat various conditions related to bile acid malabsorption. The market for cholestyramine is influenced by several key factors, including increasing health awareness, advancements in drug formulations, and demographic changes.

Market Size and Growth Prospects

The cholestyramine market is anticipated to experience significant growth over the coming years. It is projected to witness a compound annual growth rate (CAGR) of 8.23% from 2024 to 2031, transitioning from a valuation of USD 28.32 billion in 2024 to USD 49.25 billion by 2031[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Lifestyle-Related Diseases

The rising incidence of hypercholesterolemia, hyperlipidemia, and cardiovascular disorders is a major driver of the cholestyramine market. As more people adopt sedentary lifestyles and consume high-fat diets, the demand for effective cholesterol management solutions increases[1][4].

Growing Awareness About Cardiovascular Health

Enhanced awareness about the importance of managing cholesterol levels and preventing cardiovascular diseases is driving the demand for cholestyramine. Public health initiatives and educational campaigns are contributing to this increased awareness[1].

Advancements in Drug Formulations

Ongoing research and development in cholestyramine formulations aim to improve patient compliance and reduce side effects. These advancements are expected to make the drug more appealing to a broader patient base[4].

Expanding Global Healthcare Sector

The global healthcare sector, particularly in emerging markets, is expanding rapidly. Improvements in healthcare infrastructure and the availability of generic versions of cholestyramine are making the drug more accessible to a larger population[1].

Rising Geriatric Population

The increasing geriatric population, which is more prone to cholesterol-related conditions, is another significant factor driving market growth. Older adults are more likely to require cholesterol management solutions, thereby boosting demand for cholestyramine[1][4].

Market Restraints and Challenges

Fluctuating Raw Material Costs

The cost and availability of raw materials used in manufacturing cholestyramine can fluctuate, posing a challenge to the market. These fluctuations can impact production costs and profitability[4].

Availability of Alternative Medications

The presence of other effective medications for treating cholesterol-related conditions can act as a restraint. Patients and healthcare providers may opt for alternative treatments, affecting the demand for cholestyramine[4].

Market Opportunities

Ongoing R&D and Combination Therapies

Research into new formulations and combination therapies using cholestyramine offers significant opportunities for market growth. Investigating the efficacy of cholestyramine in combination with other drugs can expand its therapeutic applications[4].

Emerging Markets

Regions such as Asia-Pacific, Latin America, and the Middle East and Africa present opportunities for growth due to their large populations, rising disposable incomes, and increasing urbanization. These markets are characterized by growing demand for healthcare services and medications[1].

Regional Market Analysis

Asia-Pacific

This region is a rapidly growing market for cholestyramine, driven by countries like China, Japan, India, and South Korea. The large population, rising disposable income, and increasing urbanization in these countries are key factors contributing to market growth[1].

Europe

Europe is a mature market with well-established infrastructure and consumer preferences. Countries such as the United Kingdom, Germany, France, and Italy are significant contributors to the European cholestyramine market[1].

Americas

The Americas, including the United States, Canada, Brazil, and Mexico, are also crucial regions for the cholestyramine market. The presence of advanced healthcare systems and high awareness about cardiovascular health drive demand in these countries[4].

Middle East and Africa

The Middle East and Africa represent emerging markets with promising growth potential. Countries like the UAE, Saudi Arabia, South Africa, and Nigeria are experiencing economic diversification, urbanization, and a young population, which are driving demand for cholestyramine[1].

Competitive Landscape

Key Players

The cholestyramine market is dominated by several key players, including Sawai Pharma, Alkem Laboratories, Ajanta Pharma, Tagi Pharma, and Zydus Lifesciences. These companies are involved in strategic consolidations, such as mergers and acquisitions, to expand their product portfolios and leverage synergies[1].

Strategic Consolidations

The market is witnessing a wave of mergers and acquisitions as companies seek to strengthen their market positions. These consolidations provide access to new technologies, intellectual property, and talent, enabling companies to innovate faster and stay ahead of market trends[1].

Financial Performance and Projections

Revenue Growth

The cholestyramine market has shown steady revenue growth, with the market size increasing from USD 186.60 million in 2023 to USD 196.08 million in 2024. It is expected to continue growing at a CAGR of 5.42% over the forecast period[4].

Cost-Effective Generic Drugs

The availability of generic versions of cholestyramine has made the drug more cost-effective and accessible to a broader patient base. This shift towards generic drugs is a significant factor in the market's financial performance[1][4].

Conclusion

The cholestyramine market is poised for significant growth driven by increasing health awareness, advancements in drug formulations, and demographic changes. While the market faces challenges such as fluctuating raw material costs and the availability of alternative medications, opportunities in emerging markets and ongoing R&D offer promising prospects.

Key Takeaways

• The cholestyramine market is projected to grow at a CAGR of 8.23% from 2024 to 2031.
• Increasing prevalence of lifestyle-related diseases and growing awareness about cardiovascular health are key drivers.
• Advancements in drug formulations and expanding global healthcare infrastructure are also driving growth.
• The rising geriatric population and cost-effective generic drugs are additional factors contributing to market expansion.
• Regional markets such as Asia-Pacific, Europe, and the Americas are significant contributors to the global market.

FAQs

1. What is the projected growth rate of the cholestyramine market? The cholestyramine market is anticipated to witness a compound annual growth rate (CAGR) of 8.23% from 2024 to 2031[1].

2. What are the primary uses of cholestyramine? Cholestyramine is primarily used to lower high cholesterol levels and treat pruritus associated with partial biliary obstruction. It also removes bile acids from the body, which can help with liver problems[5].

3. Which regions are driving the growth of the cholestyramine market? The Asia-Pacific region, driven by countries like China, Japan, India, and South Korea, is a rapidly growing market. Europe and the Americas are also significant contributors[1].

4. What are the key challenges facing the cholestyramine market? The market faces challenges such as fluctuating raw material costs and the availability of alternative medications. However, ongoing R&D and emerging markets offer opportunities for growth[4].

5. Who are the key players in the cholestyramine market? Key players include Sawai Pharma, Alkem Laboratories, Ajanta Pharma, Tagi Pharma, and Zydus Lifesciences. These companies are involved in strategic consolidations to expand their market presence[1].

Sources

1. OpenPR: Cholestyramine(Colestyramine) Market Size, Share - openPR.com
2. Annual Reports: ANNUAL REPORT 2020 - AnnualReports.com
3. PR Newswire: Progressive Familial Intrahepatic Cholestasis Treatment Market - PR Newswire
4. Research and Markets: Cholestyramine Market Size, Competitors & Forecast to 2030 - Research and Markets
5. Mayo Clinic: Cholestyramine (oral route) - Mayo Clinic