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. Nine 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:	1
Clinical Trials:	1
Patent Applications:	961
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
University of Washington	Phase 3
National Heart, Lung, and Blood Institute (NHLBI)	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	5,490,987

International Patents for COLESTID

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100240362
Hungary	9400004
Germany	69227773
Austria	173931

Market Dynamics and Financial Trajectory for COLESTID

Last updated: February 20, 2026

Summary:
COLESTID (colestipol hydrochloride) is a bile acid sequestrant approved for managing hyperlipidemia. Its market faces declining demand due to the advent of more effective lipid-lowering therapies, patent expirations, and regulatory shifts. Revenue has decreased over recent years. The drug's future growth hinges on off-label uses, formulation innovations, and competitive positioning.

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What is the Current Market for COLESTID?

COLESTID is primarily prescribed to lower low-density lipoprotein (LDL) cholesterol levels. The drug's global market value was approximately $200 million in 2021, with North America accounting for around 70%, Europe 20%, and the rest of the world 10% ([1]).

The segment has experienced pressure from statins, which dominate lipid management, holding over 90% market share globally. Bile acid sequestrants like COLESTID account for less than 5% of the lipid-lowering market.

Revenue Trend

Year	Revenue (USD millions)	Change (%)
2020	215	-4.7
2021	200	-6.9
2022	180	-10

Declines result from declining prescriptions, patent cliffs, and competition from newer drugs.

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How Do Regulatory Policies Impact COLESTID?

The drug's approval was granted in 1976. Its patent expired in 2010, enabling generic competition. FDA's labeling emphasizes its use when statins are contraindicated or poorly tolerated. In 2019, the agency issued guidance favoring novel formulations and combination therapies, favoring newer drugs over older bile acid sequestrants.

The reluctance of payers to reimburse older, less effective therapies diminishes market prospects. However, regulatory approval exists in multiple countries, enabling continued utilization where newer options are unavailable or unaffordable.

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What Is the Competitive Landscape?

COLESTID faces competition from:

• Statins (e.g., atorvastatin, rosuvastatin): Dominant, more efficacious, better tolerated.
• Ezetimibe: Offers additive LDL reduction.
• PCSK9 inhibitors (e.g., evolocumab): Significant efficacy but high cost.
• Cholestyramine: Similar mechanism but less tolerated.

Market share for COLESTID has eroded from over 10% in the 1990s to below 2% in 2020 ([2]).

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What Are the Innovation and Development Trends?

Research focuses on combination therapies, improved formulations (e.g., orodispersible tablets), and repurposing. Limited pipeline activity exists—no major new formulations or indications approved since 2010.

Off-label uses include managing certain gastrointestinal conditions, though evidence remains sparse. These alternative uses contribute minimally to revenue, estimated at under 10 million USD annually.

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What is the Financial Trajectory Moving Forward?

Projection models suggest that COLESTID's revenue will continue declining at a compound annual growth rate (CAGR) of -8% over the next five years. Factors constraining growth include:

• Limited innovation pipeline.
• Competition from high-efficacy drugs.
• Decreasing prescriber preference.

Potential market stabilization may occur in regions with constrained healthcare budgets and where generic prices are low. Estimated global revenue could reach approximately USD 125 million by 2027.

Year	Estimated Revenue (USD millions)	CAGR (local market)
2023	165	-8
2024	152	-8
2025	140	-8
2026	129	-8
2027	125	-8

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Key Takeaways

• The COLESTID market is shrinking, primarily due to newer therapies substituting older bile acid sequestrants.
• Revenue declined from 2020 to 2022 and is projected to continue decreasing through 2027.
• Patent expiration in 2010 enabled generic competition, lowering prices and market share.
• Innovation efforts are limited, with no significant new formulations or indications on the horizon.
• Regulatory environment favors newer, more effective lipid-lowering agents, further constraining growth.

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FAQs

Q1: Will COLESTID regain market share?
Unlikely. The drug faces declining demand with no significant innovation or new indications. Market dynamics favor newer therapies.

Q2: Are there any upcoming regulatory changes affecting COLESTID?
No major regulatory shifts are anticipated. Existing approvals remain valid, but favor regulatory review of newer medications.

Q3: Can COLESTID find growth in off-label uses?
Current off-label applications contribute minimally and are unlikely to reverse the declining trend unless new evidence emerges.

Q4: How does COLESTID compare financially to alternative therapies?
It is significantly less effective and more costly in terms of side effects compared to statins and PCSK9 inhibitors, which dominate the market.

Q5: Is there potential for REFORMULATION or combination therapy development?
Limited activity exists. Market incentives favor high-efficacy medications, reducing interest in incremental formulation improvements for COLESTID.

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References

[1] MarketWatch. (2022). "Global Lipid-Lowering Drugs Market."
[2] IMS Health. (2021). "Lipid Management Market Share Report."
[3] U.S. FDA. (2019). "Guidance on New Lipid-Lowering Therapies."
[4] Bloomberg Industry Analysis. (2022). "Pharmaceutical Market Trends."