COLESTIPOL HYDROCHLORIDE - Generic Drug Details

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

Colestipol hydrochloride is the generic ingredient in three branded drugs marketed by Pfizer, Impax Labs, Ani Pharms, Edenbridge Pharms, and Zydus Pharms, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for colestipol hydrochloride. Eight suppliers are listed for this compound.

Summary for COLESTIPOL HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	5
NDAs:	7
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	11
Patent Applications:	662
What excipients (inactive ingredients) are in COLESTIPOL HYDROCHLORIDE?	COLESTIPOL HYDROCHLORIDE excipients list
DailyMed Link:	COLESTIPOL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for COLESTIPOL HYDROCHLORIDE

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

Sponsor	Phase
Ain Shams University	Phase 4
Laboratorios Grossman, S.A.	Phase 3
Instituto Nacional de Salud Publica, Mexico	Phase 3

See all COLESTIPOL HYDROCHLORIDE clinical trials

Pharmacology for COLESTIPOL HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for COLESTIPOL HYDROCHLORIDE

Anion Exchange Resins

Hypolipidemic Agents

Sequestering Agents

Anatomical Therapeutic Chemical (ATC) Classes for COLESTIPOL HYDROCHLORIDE

C10AC	Bile acid sequestrants
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for COLESTIPOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	GRANULE;ORAL	077277-002	May 2, 2006	AB	RX	No	No
Pfizer	FLAVORED COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pfizer	COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563-003	Sep 22, 1995	AB	RX	Yes	No
Pfizer	COLESTID	colestipol hydrochloride	TABLET;ORAL	020222-001	Jul 19, 1994	AB	RX	Yes	No
Edenbridge Pharms	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	TABLET;ORAL	217667-001	Aug 16, 2024	AB	RX	No	No
Impax Labs	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	GRANULE;ORAL	077277-001	May 2, 2006	AB	RX	No	No

Expired US Patents for COLESTIPOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FLAVORED COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563-001	Approved Prior to Jan 1, 1982
Pfizer	COLESTID	colestipol hydrochloride	TABLET;ORAL	020222-001	Jul 19, 1994
Pfizer	FLAVORED COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563-002	Approved Prior to Jan 1, 1982

COLESTIPOL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Colestipol Hydrochloride Market Dynamics and Financial Trajectory

Market Introduction

Colestipol hydrochloride, a bile acid sequestrant, was first FDA-approved in 1977 for reducing total cholesterol levels. It is commonly used in conjunction with dietary modifications to treat high blood cholesterol and has additional applications such as treating itching associated with liver illness and diarrhea after intestinal surgery[1].

Market Growth Drivers

The colestipol market is driven by several key factors:

Growing Risk of Cardiovascular Disease

High cholesterol is a significant risk factor for cardiovascular disease, a leading cause of mortality globally. As the incidence of cardiovascular disease increases, so does the demand for cholesterol-lowering medications like colestipol[1].

Aging Population

The global geriatric population is growing, and older adults are more likely to develop high cholesterol and other cardiovascular conditions. This demographic shift is expected to boost the demand for colestipol[1].

Government Initiatives

Increasing government initiatives aimed at reducing cardiovascular diseases and promoting public health also contribute to the market's growth. These initiatives often include public awareness campaigns and subsidies for healthcare services, which can increase the accessibility of cholesterol-lowering medications[1].

Market Restraints

Despite the growth drivers, there are several restraints affecting the colestipol market:

Side Effects

Colestipol is associated with side effects such as constipation, which can limit its usage. In a study, constipation was reported by 6 patients on colestipol HCl compared to 3 patients on placebo[2].

Market Segmentation

The colestipol market is segmented based on type and end user:

By Type

• Granule: This segment accounted for a significant share of the global colestipol market in 2023 and is projected to experience significant growth in the near future[3].
• Tablet: ANI Pharmaceuticals recently received FDA approval for Colestipol Hydrochloride Tablets, which is expected to expand the market[4].

By End User

• Hospital: The hospital segment is expected to expand at a significant CAGR throughout the forecast period[3].
• Drug Store: Retail pharmacies also play a crucial role in the distribution of colestipol[1].

Regional Framework

The colestipol market is analyzed across several regions:

North America

• This region is a significant market due to high healthcare spending and a large patient population with cardiovascular diseases[1].

Europe

• Europe also represents a substantial market, driven by advanced healthcare systems and high awareness of cardiovascular health[1].

Asia-Pacific (APAC)

• The APAC region is expected to grow rapidly due to increasing healthcare expenditure and a growing geriatric population[1].

Middle East and Africa (MEA) and South & Central America

• These regions are also witnessing growth, albeit at a slower pace, due to improving healthcare infrastructure and increasing government initiatives[1].

Financial Trajectory

The financial outlook for the colestipol market is promising:

Market Size and Growth Rate

• The global colestipol market size in 2023 was estimated to be in the millions, with a projected compound annual growth rate (CAGR) of XX% from 2024 to 2031[3].

Revenue Forecast

• The market is expected to grow significantly, with revenue forecasts indicating substantial increases over the forecast period. For instance, the current annual U.S. market for Colestipol Hydrochloride Tablets is approximately $81.3 million[4].

Key Players and Strategies

• Companies like Pfizer, Solara Active Pharma Sciences, and ANI Pharmaceuticals are focusing on expanding their product portfolios and business through organic and inorganic growth strategies such as product launches, acquisitions, and partnerships[1][3][4].

Competitive Landscape

The competitive landscape of the colestipol market is characterized by:

Market Leaders

• Key players in the market include Pfizer, Amneal Pharmaceuticals, Solara Active Pharma Sciences, and ANI Pharmaceuticals, among others. These companies are engaged in various strategies to strengthen their market positions[1][3].

SWOT Analysis

• The report provides detailed SWOT analyses for these companies, highlighting their strengths, weaknesses, opportunities, and threats. This analysis helps in understanding the competitive dynamics and future growth potential[1].

PEST and SWOT Analysis

The market is influenced by various external factors:

PEST Analysis

• Political, economic, social, and technological factors are evaluated to understand their impact on the colestipol market. For example, government regulations and economic conditions can significantly affect the market's growth[1].

SWOT Analysis

• This analysis provides a comprehensive overview of the market's strengths, weaknesses, opportunities, and threats. It helps in identifying potential areas for growth and mitigation of risks[1].

Future Trends and Opportunities

The colestipol market is expected to witness several trends and opportunities:

Increasing Demand

• The growing demand for cholesterol-lowering medications due to the rising incidence of cardiovascular diseases presents a significant opportunity for market growth[1].

Technological Advancements

• Advances in pharmaceutical technology could lead to the development of more effective and safer versions of colestipol, further boosting the market[3].

Expanding into New Markets

• Companies are looking to expand their presence in emerging markets, which could provide new revenue streams and growth opportunities[1].

Key Takeaways

• The colestipol market is driven by the growing risk of cardiovascular disease, an aging population, and government initiatives.
• The market is segmented by type (granule and tablet) and end user (hospital and drug store).
• Key players are focusing on organic and inorganic growth strategies to expand their market share.
• The market is expected to grow at a significant CAGR from 2024 to 2031.
• PEST and SWOT analyses highlight the market's external and internal factors influencing growth.

FAQs

Q: What is the primary use of colestipol hydrochloride? A: Colestipol hydrochloride is primarily used to reduce total cholesterol levels and treat high blood cholesterol, often in conjunction with dietary modifications[1].

Q: What are the common side effects of colestipol hydrochloride? A: The most common side effect of colestipol hydrochloride is constipation, reported by a significant number of patients in clinical studies[2].

Q: Which companies are key players in the colestipol market? A: Key players include Pfizer, Amneal Pharmaceuticals, Solara Active Pharma Sciences, and ANI Pharmaceuticals, among others[1][3][4].

Q: What is the projected growth rate of the colestipol market from 2024 to 2031? A: The colestipol market is expected to grow at a compound annual growth rate (CAGR) of XX% from 2024 to 2031[3].

Q: What regions are expected to drive the growth of the colestipol market? A: North America, Europe, and the Asia-Pacific region are expected to be significant drivers of the colestipol market growth due to their large patient populations and advanced healthcare systems[1].

Sources

1. The Insight Partners, "Colestipol Market Dynamics 2021-2031"
2. PubMed, "Cholesterol-lowering effect of colestipol hydrochloride given twice daily"
3. Cognitive Market Research, "Colestipol Market Report 2024 (Global Edition)"
4. ANI Pharmaceuticals, "ANI Pharmaceuticals Announces the FDA Approval of Colestipol Hydrochloride Tablets USP"