COLESTID Drug Patent Profile

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

Colestid is a drug marketed by Pfizer and is included in two NDAs.

The generic ingredient in COLESTID is colestipol hydrochloride. There are two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the colestipol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Colestid

A generic version of COLESTID was approved as colestipol hydrochloride by IMPAX LABS on May 2^nd, 2006.

Summary for COLESTID

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	1
Patent Applications:	332
Drug Prices:	Drug price information for COLESTID
What excipients (inactive ingredients) are in COLESTID?	COLESTID excipients list
DailyMed Link:	COLESTID at DailyMed

See drug prices for COLESTID

Recent Clinical Trials for COLESTID

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

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3
University of Washington	Phase 3

See all COLESTID clinical trials

Pharmacology for COLESTID

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

US Patents and Regulatory Information for COLESTID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563-003	Sep 22, 1995	AB	RX	Yes	No
Pfizer	COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563-004	Sep 22, 1995	AB	RX	Yes	Yes
Pfizer	COLESTID	colestipol hydrochloride	TABLET;ORAL	020222-001	Jul 19, 1994	AB	RX	Yes	No

Expired US Patents for COLESTID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	COLESTID	colestipol hydrochloride	TABLET;ORAL	020222-001	Jul 19, 1994

International Patents for COLESTID

See the table below for patents covering COLESTID around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	935943
Finland	106843
Canada	2110166	FABRICATION DE COMPRIMES D'HYDROCHLORIDE DE COLESTIPOL (TABLETING OF COLESTIPOL HYDROCHLORIDE)

COLESTID Market Analysis and Financial Projection Experimental

Colestipol Market Dynamics and Financial Trajectory: A Comprehensive Overview

Introduction to Colestipol

Colestipol, a bile acid sequestrant, has been a cornerstone in the treatment of high blood cholesterol since its FDA approval in 1977. It is used as an adjunctive therapy to diet for reducing elevated serum total and low-density lipoprotein (LDL) cholesterol levels.

Market Introduction

Colestipol is available in two primary forms: granules and tablets. Both forms work by increasing the fecal loss of bile acids, which in turn increases the hepatic uptake of LDL and reduces serum cholesterol levels[2][4].

Market Dynamics

Drivers

• Growing Risk of Cardiovascular Disease: The increasing global risk of cardiovascular disease, closely linked to high cholesterol levels, is a significant driver for the colestipol market. High cholesterol is a major risk factor for cardiovascular diseases, making colestipol a vital treatment option[1].
• Aging Population: The growing geriatric population worldwide is another key driver. Older adults are more likely to develop hypercholesterolemia, thereby increasing the demand for colestipol[1].
• Government Initiatives: Increasing government initiatives aimed at reducing cardiovascular diseases and promoting public health also propel the market's growth[1].

Restraints

• Side Effects: Despite its benefits, colestipol can cause side effects such as gastrointestinal issues, which can limit its usage. Patients may experience constipation, abdominal pain, and other digestive problems, making it less appealing to some[1].
• Alternative Treatments: The availability of other lipid-lowering agents, such as statins and fibrates, can also act as a restraint. These alternatives may offer different benefits and side effect profiles that could attract patients and healthcare providers[2][4].

Market Segmentation

By Type

• Granules: Colestipol granules are often flavored to improve palatability and are commonly used for patients who have difficulty swallowing tablets. They are effective in reducing LDL cholesterol levels when used as part of a dietary regimen[2][4].
• Tablets: Colestipol tablets are another form of the drug, offering a more convenient option for some patients. They work similarly to the granules by reducing LDL cholesterol through increased bile acid excretion[4].

By End User

• Hospitals: Hospitals are a significant segment for colestipol, particularly for patients requiring intensive care and specific dosing guidelines. Hospital pharmacies often provide a broader range of medications and customized advice, enhancing patient outcomes[5].
• Drug Stores: Drug stores also play a crucial role in the distribution of colestipol, making it accessible to a wider population. This segment is vital for patients managing their cholesterol levels through outpatient care[3].

Regional Framework

The colestipol market is analyzed across five major regions: North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America.

• North America: This region is expected to hold a significant share due to the high usage of bile acid sequestrants in treating conditions like pruritus in liver cirrhosis patients. The region's advanced healthcare infrastructure and high awareness of cholesterol management also contribute to its market size[5].
• Europe: Europe is anticipated to see substantial growth due to the increasing prevalence of type 2 diabetes and cardiovascular disorders. Technological advancements in drug delivery methods and the development of novel medications are expected to provide lucrative growth opportunities[5].
• Asia-Pacific: The APAC region is growing rapidly due to an increasing geriatric population and rising awareness of cardiovascular health. Government initiatives and improving healthcare infrastructure are also driving the market in this region[1].

Market Size and Forecast

• Current Market Size: The colestipol market size in 2023 is estimated to be in the range of US$ XX Million[1].
• Forecasted Growth: The market is projected to grow at a CAGR of XX% between 2023 and 2031, reaching a market size of US$ XX Million by 2031[1].
• Historical Data: The report provides historical data from 2021 to 2022, which helps in understanding the market's past trends and predicting future growth[1].

Competitive Landscape

The colestipol market is competitive, with several key players:

• Pfizer: Known for its extensive pharmaceutical portfolio, Pfizer is a major player in the colestipol market[3].
• Amneal Pharmaceuticals: Amneal Pharmaceuticals is another significant player, focusing on generic and specialty pharmaceuticals[3].
• Solara Active Pharma Sciences: This company is involved in the development and manufacturing of various pharmaceutical products, including colestipol[3].
• Cadila Healthcare: Cadila Healthcare is a prominent player in the Indian pharmaceutical market and has a global presence in the colestipol segment[3].

These companies are adopting various growth strategies such as product launches, partnerships, and acquisitions to expand their market share[1].

Financial Trajectory

Revenue and Volume Forecast

The colestipol market is expected to see significant revenue growth driven by the increasing demand for lipid-lowering agents. The market size is forecasted to grow from US$ XX Million in 2023 to US$ XX Million by 2031, with a CAGR of XX% during the forecast period[1].

Key Statistics

• Market Size Value/Volume: The report provides detailed market size value and volume forecasts globally, regionally, and by country[1].
• Industry and Competitive Landscape: The competitive landscape includes key statistics on the market status of leading players, their market strategies, and financial information over the last three years[1].

PEST Analysis

The report includes a comprehensive PEST analysis for all five regions, evaluating political, economic, social, and technological factors affecting the colestipol market. This analysis helps in understanding the macro-environmental factors that could impact the market's growth[1].

Growth Opportunities and Trends

• Increasing Prevalence of Hyperlipidemia: The growing number of cases of hyperlipidemia worldwide is a significant trend driving the market. Approximately 10% of adults aged 20 or older worldwide have hyperlipidemia, which is expected to increase the demand for colestipol[5].
• Continuous Research and Development: Ongoing research in the field of bile acid sequestrants, including new drug developments and improved delivery methods, is expected to further boost the market[5].

Challenges

• Side Effects and Contraindications: The potential side effects and contraindications of colestipol, such as gastrointestinal issues and the need to exclude secondary causes of hypercholesterolemia, can limit its adoption[2][4].
• Competition from Other Lipid-Lowering Agents: The presence of other lipid-lowering agents, such as statins and fibrates, poses a challenge to the colestipol market. These alternatives may offer different benefits and side effect profiles that could attract patients and healthcare providers[2][4].

Key Takeaways

• The colestipol market is driven by the growing risk of cardiovascular disease and an aging population.
• The market is segmented by type (granules and tablets) and end user (hospitals and drug stores).
• North America and Europe are expected to hold significant shares due to high usage and advanced healthcare infrastructure.
• Key players are adopting various growth strategies to expand their market share.
• The market is expected to grow at a CAGR of XX% between 2023 and 2031.

FAQs

What is the primary use of colestipol?

Colestipol is primarily used as an adjunctive therapy to diet for reducing elevated serum total and LDL cholesterol levels in patients with primary hypercholesterolemia[2][4].

Which regions are expected to dominate the colestipol market?

North America and Europe are expected to hold significant shares in the colestipol market due to high usage and advanced healthcare infrastructure[5].

What are the common side effects of colestipol?

Common side effects of colestipol include gastrointestinal issues such as constipation, abdominal pain, and increased triglyceride levels in some patients[1][2].

Who are the key players in the colestipol market?

Key players include Pfizer, Amneal Pharmaceuticals, Solara Active Pharma Sciences, Cadila Healthcare, and Mylan[3].

What is the forecasted growth rate of the colestipol market?

The colestipol market is projected to grow at a CAGR of XX% between 2023 and 2031[1].

Sources

1. The Insight Partners: Colestipol Market Dynamics 2021-2031.
2. DailyMed: COLESTID- colestipol hydrochloride granule, for suspension.
3. Valuates Reports: Colestipol Market.
4. DailyMed: COLESTID- colestipol hydrochloride tablet.
5. Research Nester: Bile Acid Sequestrants Market Size & Share | Growth Report 2036.