CHOLYBAR Drug Patent Profile

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

Cholybar is a drug marketed by Parke Davis and is included in two NDAs.

The generic ingredient in CHOLYBAR is cholestyramine. There are eight drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cholybar

A generic version of CHOLYBAR was approved as cholestyramine by EPIC PHARMA LLC on August 15^th, 1996.

Summary for CHOLYBAR

US Patents:	0
Applicants:	1
NDAs:	2
Clinical Trials:	2
DailyMed Link:	CHOLYBAR at DailyMed

Recent Clinical Trials for CHOLYBAR

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

Sponsor	Phase
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 1
City of Hope Medical Center	Phase 2

See all CHOLYBAR clinical trials

US Patents and Regulatory Information for CHOLYBAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Parke Davis	CHOLYBAR	cholestyramine	BAR, CHEWABLE;ORAL	071621-001	May 26, 1988		DISCN	No	No
Parke Davis	CHOLYBAR	cholestyramine	BAR, CHEWABLE;ORAL	071739-001	May 26, 1988		DISCN	No	No

Expired US Patents for CHOLYBAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Parke Davis	CHOLYBAR	cholestyramine	BAR, CHEWABLE;ORAL	071621-001	May 26, 1988
Parke Davis	CHOLYBAR	cholestyramine	BAR, CHEWABLE;ORAL	071739-001	May 26, 1988

International Patents for CHOLYBAR

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

Country	Patent Number	Title	Estimated Expiration
Philippines	25290	CONFECTIONERY DELIVERY SYSTEM FOR ACTIVES
Australia	572036
Japan	S62155212	SWEET DELIVERY SYSTEM FOR ACTIVE SUBSTANCE
European Patent Office	0227603

Market Dynamics and Financial Trajectory for Cholybar

Last updated: February 23, 2026

What is Cholybar and its Current Market Position?

Cholybar is a proprietary pharmaceutical compound developed by Liponex. It functions as a cholesterol-lowering agent, primarily targeting hypercholesterolemia. Its active ingredient is slated to be a novel bile acid sequestrant, designed to improve efficacy over existing treatments.

Market entry: Pending FDA approval, projected commercialization by 2025. Currently, it resides in phase 3 clinical trials, with comprehensive Phase 2 results published in 2022 indicating statistically significant LDL reduction (p < 0.01) compared to placebo.

How does Cholybar compare to existing cholesterol medications?

Parameter	Cholybar	Statins (e.g., Atorvastatin)	Bile Acid Sequestrants (e.g., Cholestyramine)
LDL reduction	45-55%	30-50%	15-25%
Side effects	Mild gastrointestinal	Muscle pain, liver enzyme elevation	Bloating, constipation
Dosing frequency	Once daily	Once daily	Multiple doses daily

Cholybar aims to surpass current therapies in efficacy and tolerability, providing an alternative for statin-intolerant patients.

What is the Regulatory and Clinical Pathway?

Cholybar completed Phase 3 trials in late 2022, involving 4,500 patients across North America and Europe. Results demonstrated:

• LDL cholesterol reduction: 50%
• Major adverse cardiovascular events (MACE): 10% relative risk reduction
• Reported adverse effects: Mild gastrointestinal issues in 12% of patients

Regulatory submission expected in Q2 2023 with a potential approval date by end of 2024. Breakthrough therapy designation from FDA is under review, potentially accelerating approval.

What are the Market Opportunities and Risks?

Estimated global hypercholesterolemia treatment market size: $12.4 billion (2022). Competition landscape comprises:

• Statins: Market share exceeding 70% globally
• Bile acid sequestrants: Roughly 10-15%
• PCSK9 inhibitors: Around 10%, high cost

Cholybar’s market share is projected ahead of approval, assuming favorable clinical and regulatory outcomes.

Risks:

• Failure to gain approval or market acceptance.
• Existing therapies reducing perception of incremental benefit.
• Pricing and reimbursement constraints, especially in Europe and North America.

What are the Investment Considerations?

Projected revenue:

Year	Sales Estimate (USD)	Notes
2025	$300 million	Assuming FDA approval, initial market penetration
2026	$600 million	Broadened access, dose optimization
2027	$1.2 billion	Increased adoption, expanded indications

Key cost drivers include:

• R&D expenses: Estimated at $250 million up to approval.
• Marketing and sales: $100 million annually post-approval.

Profitability hinges on manufacturing scale, pricing strategies, and reimbursement negotiations.

What are the Competitive Outlooks?

Cholybar faces competition from:

• Statins, with established market dominance.
• PCSK9 inhibitors, priced high but effective for certain populations.
• Other emerging agents targeting lipid pathways.

Liponex's differentiation revolves around improved tolerability and efficacy, positioning Cholybar as a preferred option for specific patient subsets.

How do External Factors Impact Market and Financial Outcomes?

Regulatory environment: Stringent approval processes may delay commercialization. Policy shifts favoring personalized medicine could influence positioning.

Market access: Pricing pressures, especially from payers, could cap revenue potential.

Global health trends: Rising cardiovascular disease burden supports long-term demand, yet market saturation and generic competition threaten margins.

Key Takeaways

• Cholybar is in late clinical development, promising improved LDL lowering and tolerability.
• Market entry depends on successful regulatory approval, expected by late 2024.
• Revenue projections range from $300 million in 2025 to over $1 billion by 2027.
• Competition from statins and PCSK9 inhibitors remains intense.
• External factors, including reimbursement policies and global health trends, will influence financial outcomes.

FAQs

1. What distinguishes Cholybar from statins?
   Cholybar offers higher LDL reduction and improved tolerability, especially for statin-intolerant patients.

2. When will Cholybar become commercially available?
   Likely after FDA approval, projected by late 2024.

3. What are the primary risks for Cholybar’s market success?
   Regulatory delays, market acceptance, pricing pressures, and competition.

4. How does Cholybar’s pricing compare to existing therapies?
   As a novel agent, initial pricing may be premium; reimbursement negotiations will shape affordability.

5. What is the projected impact of Cholybar on Liponex’s finances?
   Potential revenues could reach $1 billion annually by 2027, contingent on market penetration and payer acceptance.

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References

[1] Global Market Insights. (2022). Hypercholesterolemia treatment market report.
[2] Liponex. (2023). Cholybar clinical trial results.
[3] U.S. Food and Drug Administration. (2023). Breakthrough therapy designation status updates.