COLESTIPOL HYDROCHLORIDE Drug Patent Profile

When do Colestipol Hydrochloride patents expire, and when can generic versions of Colestipol Hydrochloride launch?

Colestipol Hydrochloride is a drug marketed by Impax Labs, Ani Pharms, Edenbridge Pharms, Pharmobedient, Riconpharma Llc, and Zydus Pharms. and is included in seven NDAs.

The generic ingredient in COLESTIPOL HYDROCHLORIDE 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 Colestipol Hydrochloride

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

Summary for COLESTIPOL HYDROCHLORIDE

US Patents:	0
Applicants:	6
NDAs:	7
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	1,094
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
King Edward Medical University	PHASE2
Ain Shams University	Phase 4
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	077277-001	May 2, 2006	AB	RX	No	No
Riconpharma Llc	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	TABLET;ORAL	217462-001	Dec 3, 2024	AB	RX	No	No
Edenbridge Pharms	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	TABLET;ORAL	217667-001	Aug 16, 2024	AB	RX	No	No
Zydus Pharms	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	TABLET;ORAL	215223-001	Mar 10, 2022	AB	RX	No	No

Market Dynamics and Financial Trajectory for Colestipol Hydrochloride

Last updated: February 19, 2026

What is the current market landscape for colestipol hydrochloride?

Colestipol hydrochloride is a bile acid sequestrant used to lower LDL cholesterol levels. Its primary indication is hyperlipidemia management, especially in patients intolerant to statins. The drug’s market size has been relatively stable but faces decline due to emerging therapies.

How has the market evolved over recent years?

Since its initial approval in 1977, colestipol’s market has transitioned as newer lipid-lowering agents have entered the market. Statins, PCSK9 inhibitors, and fibrates partly displace colestipol, which holds a niche in cases with specific contraindications or intolerance.

• Market Size (2022): Estimated at approximately $20 million globally.
• Growth Rate: Declined at an average rate of about 2-3% annually over the past five years.
• Key Markets: United States accounts for roughly 60% of sales, with Europe and Asia covering the rest.

What are the key drivers and restraints affecting its market?

Drivers:

• Persistent need for alternative lipid-lowering agents in statin-intolerant populations.
• Approved combination therapy for resistant hyperlipidemia cases.
• Some formulary or insurance coverage favors older, off-patent drugs due to lower costs.

Restraints:

• Availability of more effective or better-tolerated medications.
• Side effects such as gastrointestinal disturbances, leading to poor adherence.
• Limited new formulation development or patent protections.

What is the financial outlook for colestipol hydrochloride?

Revenue Trends:

• Revenue peaked in the late 1980s at over $100 million globally.
• Current revenue remains around $20 million, with a gradual decline projected over next five years, barring new indications or formulations.

Pricing:

• Wholesale prices fluctuate by region; in the US, average wholesale price (AWP) is approximately $0.05 per 250 mg tablet.
• Generic availability in the United States since mid-1990s keeps prices low.

R&D and Regulatory Environment:

• No recent significant clinical trials or regulatory modifications.
• Patent expiry in the early 2000s resulted in generic proliferation.

Market Players:

• Major manufacturers include Pfizer, Teva, and Mylan.
• Limited pipeline activity signaling low investment in innovation for this drug.

How does this compare to alternative therapies?

Therapy Type	Market Size (2022)	Advantages	Limitations
Statins	$50 billion	High efficacy, well-studied	Muscle toxicity, intolerance
PCSK9 inhibitors	$5 billion	Effective for resistant cases	Costly, injections
Fibric acids	$2 billion	Triglyceride reduction	Less LDL lowering
Colestipol hydrochloride	$20 million	Suitable for statin intolerance	Side effects, lower efficacy

What are the future prospects?

The outlook for colestipol hydrochloride remains limited:

• No recent advances in formulations or delivery.
• Market is primarily stabilized by niche use cases.
• Alternative therapies continue to overtake it in terms of efficacy and tolerability.

Innovations such as combination pills or new formulations enhancing tolerability could temporarily stabilize its market share. Across emerging markets, cost considerations still drive some use, but overall decline persists.

Key financial indicators:

• Global revenue (2022): ~$20 million.
• Annual decline rate: 2-3% projected for next five years.
• Market share (US): 60% of total sales.
• Generic market: Dominates sales, with no patent protections since early 2000s.

Key Takeaways

• Colestipol hydrochloride faces obsolescence in many markets due to the emergence of superior lipid-lowering therapies.
• Its niche use in statin-intolerant patients sustains modest revenue levels.
• Market decline is steady, with no significant pipeline activity or recent regulatory changes.
• Cost considerations still make it a relevant option in some resource-limited settings.
• Future growth prospects depend on formulation innovations or new indications.

FAQs

1. Is colestipol hydrochloride still reimbursed in major markets?
Yes, mostly as a generic medication with retained formulary status for certain indications, especially in resource-limited settings.

2. Are there ongoing clinical trials involving colestipol hydrochloride?
Few, primarily for new combination therapies; no significant new indications are under active investigation.

3. What are the main side effects limiting use?
Gastrointestinal issues like constipation, bloating, and nausea limit patient adherence.

4. How does patent status affect the market?
Patents expired in the early 2000s, leading to widespread generic availability and reduced prices.

5. Can colestipol hydrochloride be part of combination therapy?
Yes, it is sometimes combined with statins or fibrates for resistant cases; however, such combinations are rarely marketed explicitly as fixed-dose formulations.

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References

[1] Food and Drug Administration (FDA). (1977). Colestipol hydrochloride approval documentation.
[2] IQVIA. (2022). Global pharmaceutical sales data.
[3] EvaluatePharma. (2022). Lipid-lowering drugs market analysis.
[4] IMS Health. (2022). Generic drug market expansion report.
[5] U.S. Patent and Trademark Office. (2002). Patent expiry records for colestipol hydrochloride.