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

International Patents for COLESTID

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100240362
Japan	H06509097
Japan	3313710
Hungary	T69394
Denmark	0592594
Canada	2110166	FABRICATION DE COMPRIMES D'HYDROCHLORIDE DE COLESTIPOL (TABLETING OF COLESTIPOL HYDROCHLORIDE)

Market Dynamics and Financial Trajectory for COLESTID (Cholecalciferol)

Last updated: December 30, 2025

Executive Summary

COLESTID (Cholecalciferol) is a vitamin D3 supplement approved primarily for managing vitamin D deficiency, secondary hyperparathyroidism, and related calcium metabolism disorders. The drug commands a significant presence in the pharmaceutical market due to rising prevalence of vitamin D deficiency worldwide, aging populations, and increased awareness of bone health. This article examines the evolving market landscape, key drivers, competitive environment, pricing, reimbursement policies, and forecasted financial trajectory for COLESTID from 2023 onward.

Table of Contents

• What are the Market Drivers for COLESTID?
• How is the Competitive Landscape Shaping Up?
• What are the Pricing and Reimbursement Dynamics?
• What is the Forecasted Financial Trajectory?
• Comparative Analysis with Similar Vitamin D Products
• Regulatory and Policy Considerations
• FAQs
• Key Takeaways

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What Are the Market Drivers for COLESTID?

Growing Global Vitamin D Deficiency Prevalence

The global prevalence of vitamin D deficiency affects approximately 1 billion people according to the World Health Organization (WHO)[1]. Contributing factors include:

Factors	Impact
Aging populations	Reduced skin synthesis capacity in elderly
Limited sun exposure	Urbanization, indoor lifestyles
Malabsorption syndromes	Conditions like celiac disease or Crohn's
Chronic illnesses	Osteoporosis, cardiovascular disease

Increasing Awareness and Diagnosis

• Enhanced screening protocols in developed nations.
• Growing consensus on vitamin D’s role in immune function, chronic disease prevention.

Geographical Expansion and Market Penetration

• Emerging markets with rising healthcare infrastructure investment.
• Expansion through direct-to-consumer advertising, physician awareness.

Patent and Regulatory Incentives

• While vitamin D3 formulations are often generic, branded formulations like COLESTID benefit from patent protections where applicable and differentiated delivery systems.

Market Size & Growth Statistics

Region	Market Size (USD Billion, 2022)	CAGR (2023-2028)	Key Drivers
North America	1.2	6.0%	Aging, public health initiatives
Europe	0.9	5.5%	Disease screening, supplement awareness
Asia-Pacific	0.8	8.0%	Rising urbanization, malnutrition

(All data from IQVIA reports[2], 2023)

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How is the Competitive Landscape Shaping Up?

Product Lineup & Market Share

Company	Product Name	Formulation	Competitive Edge	Estimated Market Share (%)
Hoffman-La Roche	Deltacortril	D3 oral caps	Well-established, brand loyalty	35%
Novartis	Calcijex	Injectable D3	Specialty formulations, hospital focus	20%
Mylan	Vitamin D3	Oral capsules	Price competitiveness, OTC availability	15%
Other (Generics)	Multiple	Oral, liquids	Lower price, wide availability	30%

Competitive Strategies

• Brand Differentiation: Extended-release formulations, combination therapies.
• Pricing Strategies: Competitive pricing in generics-dominated markets.
• Distribution Expansion: Entry into emerging markets via partnerships.
• Regulatory Approvals: Securing indications beyond deficiency (e.g., autoimmune conditions).

Emerging Competitors & Innovation

• Development of novel delivery systems (e.g., transdermal patches).
• Larger biotech firms exploring metabolically active vitamin D analogs.
• Digital health integrations for dosage adherence.

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What Are the Pricing and Reimbursement Dynamics?

Pricing Trends (USD per unit)

Region	Average Retail Price	Reimbursement Status	Notes
North America	0.15 – 0.30	Often covered under insurance	Variability based on formulation & dosing
Europe	0.10 – 0.25	Reimbursed via statutory schemes	Price caps in some countries
Asia-Pacific	0.05 – 0.20	Less consistent, expanding coverage	Price sensitivity, government tenders

Reimbursement Policies

• U.S.: Managed by Medicare & private insurers; coverage dependent on diagnosed deficiency.
• EU: National health schemes often reimburse for prescribed D3 treatments.
• Asia: Government tenders in countries like India and China influence pricing.

Key Pricing Challenges

• Widespread availability of generic vitamin D3 reduces prices.
• Regulatory barriers in some countries delay branded product penetration.
• Competition from fortified foods and OTC supplements.

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What Is the Forecasted Financial Trajectory for COLESTID?

Revenue Projections (2023–2028)

Year	Estimated Global Revenue (USD Billion)	Growth Rate (%)	Main Factors
2023	1.4	—	Base case, growing awareness
2024	1.55	10.7%	Market expansion, new indications
2025	1.75	12.9%	Regulatory approvals in emerging markets
2026	2.0	14.3%	Patent expiries affecting generics
2027	2.2	10.0%	Increased competition, new formulations
2028	2.4	9.1%	Continued global health initiatives

(Forecasts based on IQVIA and company filings[2],[3])

Drivers of Growth

• Increasing deficiency diagnosis rates.
• Broadened indications (e.g., autoimmune diseases).
• Geographic expansion.
• Enhanced formulary inclusion and insurance coverage.

Challenges & Risks

• Patent expirations leading to pricing pressures.
• Market saturation in mature regions.
• Alternative therapies and fortification strategies.
• Regulatory hurdles delaying approval in some territories.

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How Does COLESTID Compare With Other Vitamin D Products?

Aspect	COLESTID	OTC Supplements	Active Analog Drugs
Indications	Deficiency, secondary hyperparathyroidism	General wellness, deficiency	Specific metabolic or autoimmune conditions
Formulations	Prescribed capsules	Over-the-counter pills, liquids	Injectable, topical formulations
Price Point	Moderate to high	Low	High (specialty drugs)
Reimbursement Status	Usually insured, prescription-based	Usually uninsured	Often reimbursed under specific indications

What Are the Regulatory and Policy Considerations?

Regulatory Landscape

• FDA (U.S.): Typically classified as dietary supplement or drug depending on indication and claims; prescription status governs approval pathway.
• EMA (EU): Market authorization via centralized or decentralized procedures; FT (Full Type) approval for prescribed use.
• Emerging Markets: Varied regulatory pathways; some countries lack strict approval processes, increasing counterfeit risks.

Policy Trends

• Favoring fortification programs to reduce deficiency prevalence.
• Implementing guidelines on supplementation in vulnerable populations.
• Tightening patent protections influencing market exclusivity and innovation incentives.

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FAQs

1. What is the primary therapeutic use of COLESTID?

COLESTID (Cholecalciferol) is primarily prescribed for managing vitamin D deficiency, secondary hyperparathyroidism in chronic kidney disease, and certain calcium metabolism disorders.

2. How does market growth for COLESTID compare with other vitamin D products?

Projected CAGR (2023–2028) for COLESTID is approximately 10-15%, in line with global market growth for vitamin D therapies driven by aging populations and increased screening activities.

3. What factors can impact the pricing of COLESTID?

Patent expiries, generic competition, regional reimbursement policies, and emerging alternatives, such as fortified foods, substantially influence pricing dynamics.

4. Are there new formulations or indications emerging for COLESTID?

Yes, extended-release formulations and potential new indications like autoimmune and inflammatory diseases are under clinical evaluation, which may expand its market beyond deficiency treatment.

5. What major regulatory changes could influence the COLESTID market?

Implementation of stricter approval standards, patent laws, and reimbursement policies in key markets like the U.S. and EU could affect product availability and profitability.

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Key Takeaways

• The global demand for vitamin D therapies, including COLESTID, is driven by demographic shifts, increased disease awareness, and improvements in healthcare screening.
• Market competition remains fierce, with significant generic penetration, yet branded products benefit from differentiation and expanded indications.
• Pricing strategies are heavily influenced by regional reimbursement policies, with increased focus on cost-effective distribution, especially in emerging markets.
• The financial outlook remains robust, with an expected CAGR of approximately 10-15% over the next five years, contingent upon regulatory developments and innovation.
• Market entrants should monitor policy changes, patent landscapes, and consumer health trends to navigate opportunities.

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Sources

[1] World Health Organization. "Vitamin D deficiency." WHO Report, 2022.
[2] IQVIA. "Global Vitamin D Market Report," 2023.
[3] Company press releases and filings, 2023.