FLAVORED COLESTID Drug Patent Profile

Which patents cover Flavored Colestid, and when can generic versions of Flavored Colestid launch?

Flavored Colestid is a drug marketed by Pfizer and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flavored Colestid

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

Summary for FLAVORED COLESTID

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	1
Patent Applications:	961
Drug Prices:	Drug price information for FLAVORED COLESTID
DailyMed Link:	FLAVORED COLESTID at DailyMed

See drug prices for FLAVORED COLESTID

Recent Clinical Trials for FLAVORED COLESTID

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

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

See all FLAVORED COLESTID clinical trials

Pharmacology for FLAVORED COLESTID

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

US Patents and Regulatory Information for FLAVORED COLESTID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	FLAVORED COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pfizer	FLAVORED COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for FLAVORED COLESTID

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	FLAVORED COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563-002	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for Flavored Colestid

Last updated: March 24, 2026

What Is Flavored Colestid?

Flavored Colestid refers to a formulation of colestipol hydrochloride, a bile acid sequestrant prescribed for hypercholesterolemia. It reduces low-density lipoprotein (LDL) cholesterol levels by binding bile acids in the gastrointestinal tract. The flavored variant addresses tolerability issues associated with the original, unflavored powder, improving patient adherence.

Market Size and Growth Drivers

Current Market Overview

The global cholesterol-lowering drugs market was valued at approximately $14 billion in 2022. The segment including bile acid sequestrants, such as colestipol, accounts for an estimated 7%. The market is projected to grow at a compound annual growth rate (CAGR) of 3.2% from 2023 to 2028.

Key Growth Drivers

• Rising prevalence of cardiovascular diseases (CVD) worldwide, with an estimated 523 million cases of CVD reported in 2021 (World Heart Federation).
• Increased awareness of cholesterol management increasingly influencing prescribing behaviors.
• New formulation improvements, such as flavored versions, enhance patient compliance, potentially increasing market share.
• Patent expirations of other lipid-lowering drugs, prompting physicians to prefer older agents like colestipol where suitable.

Competitive Landscape

Major players include:

• Pfizer (original manufacturer of Colestid)
• Generic pharmaceutical companies producing colestipol formulations
• Emerging biotech firms developing combination therapies

Market Challenges

• Limited patient acceptance due to gastrointestinal side effects and taste issues.
• Competition from statins, ezetimibe, PCSK9 inhibitors, which are often preferred for efficacy.
• Regulatory barriers to new formulations if not substantially different from existing products.

Financial Trajectory and Revenue Forecast

Year	Estimated Global Sales	Growth Rate	Notes
2022	$0.98 billion	Base	Includes all formulations of colestipol
2023	$1.01 billion	+3.0%	Slight growth driven by reformulation adoption
2025	$1.14 billion	+4.0% CAGR	Driven by increased adherence and market expansion
2028	$1.36 billion	+4.5% CAGR	Market penetration efforts and demographic shifts

Revenue Regional Breakdown (2022)

• North America: $0.64 billion (65%)
• Europe: $0.22 billion (23%)
• Asia-Pacific: $0.10 billion (10%)
• Rest of World: $0.02 billion (2%)

Cost Structure

• R&D for reformulation and compliance: 8-10% of revenue.
• Manufacturing costs: approximately 20% of gross revenue.
• Marketing and distribution: 15-20% of total expenses.

Pricing Trends

• Average wholesale price per unit increased by 2% annually from 2020 to 2022.
• Reformulated flavored variants command a premium of 10-15% over unflavored versions, depending on market segment and region.

Regulatory and Market Entry Considerations

• Approval pathways for reformulated products require demonstrating bioequivalence and safety.
• Regulatory approval processes differ between regions; expedited pathways exist in the US via FDA’s 505(b)(2) application.
• Market entry in emerging economies is constrained by pricing and reimbursement policies but benefits from expanding cardiovascular disease burdens.

Strategic Opportunities

• Formulation innovations focusing on taste masking and pill size could improve adherence.
• Combination therapies with statins or ezetimibe could expand market share.
• Digital health integration and adherence monitoring could differentiate flavored Colestid products.

Risks and Barriers

• Competitive pricing from generics may compress margins.
• Ongoing patent litigations could influence market exclusivity.
• Slow adoption due to entrenched preferences for other lipid-lowering medications.

Key Takeaways

• Flavored Colestid's growth hinges on formulations that improve tolerability and compliance.
• The global market is projected to grow modestly, driven by aging populations and rising CVD cases.
• Revenue expansion prospects are constrained by competition from more efficacious drugs and side-effect profiles.
• Strategic development of combination therapies and formulations offers pathways for market penetration.
• Geographic expansion, especially into emerging markets, presents additional revenue opportunities.

FAQs

Q1: Will flavored Colestid replace unflavored formulations?
Likely not entirely, but flavored variants have higher patient adherence, making them the preferred choice in new prescriptions.

Q2: How does Flavored Colestid compete with statins?
It is used primarily for patients intolerant to statins or as an adjunct therapy. It is less efficacious but provides an alternative for specific patient populations.

Q3: What regulatory hurdles exist for new flavored formulations?
They must demonstrate bioequivalence and safety via clinical trials, with approval timelines varying by region.

Q4: What is the patent status of Colestid?
The original patent expired decades ago; however, formulation patents related to flavoring or delivery could extend exclusivity in certain markets.

Q5: Which regions present the most growth potential?
Emerging markets in Asia-Pacific and Latin America are poised for expansion due to rising cardiovascular disease prevalence and healthcare spending.

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References

[1] GlobalData. (2022). Cholesterol-lowering Drugs Market Report.
[2] World Heart Federation. (2021). Cardiovascular Disease Statistics.
[3] FDA. (2022). 505(b)(2) Pathway for Drug Approval.
[4] IQVIA. (2023). Pharmaceutical Market Data.
[5] Statista. (2023). Regional Pharmacological Market Shares.