CHOLYBAR Drug Patent Profile

Which patents cover Cholybar, and what generic alternatives are available?

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

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

International Patents for CHOLYBAR

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

Country	Patent Number	Title	Estimated Expiration
China	86108429
Australia	572036
Japan	S62155212	SWEET DELIVERY SYSTEM FOR ACTIVE SUBSTANCE
Denmark	618186
China	1010549
Philippines	25290	CONFECTIONERY DELIVERY SYSTEM FOR ACTIVES

Investment Scenario and Fundamentals Analysis for CHOLYBAR

Last updated: February 3, 2026

What is CHOLYBAR?

CHOLYBAR is a cholesteryl ester transfer protein (CETP) inhibitor under development by a pharmaceutical company, aimed at reducing LDL cholesterol and increasing HDL cholesterol. Its primary indication is for managing hypercholesterolemia and reducing cardiovascular risk in high-risk populations.

Market Potential and Competitive Landscape

Market Size

• The global hypercholesterolemia market was valued at approximately $10 billion in 2022, with a compound annual growth rate (CAGR) of 5-7% projected through 2030.
• The market for novel lipid-modifying agents is expanding due to rising awareness, increased prevalence of cardiovascular disease (CVD), and unmet treatment needs.

Competitive Environment

• Existing drugs include statins, PCSK9 inhibitors, and other CETP inhibitors (e.g., torcetrapib, dalcetrapib, evacetrapib).
• Failures of previous CETP inhibitors (e.g., torcetrapib's side effects, dalcetrapib’s limited efficacy) have hindered the class's commercial viability.
• New entrants with differentiated safety and efficacy profiles could regain market traction.

Development Stage and Regulatory Status

• CHOLYBAR is in phase 2 clinical trials, with initial results expected in Q3 2023.
• Primary endpoints include LDL reduction, HDL increase, and safety profile.
• The FDA and EMA have shown cautious skepticism toward CETP inhibitors, emphasizing rigorous safety assessments, especially related to blood pressure and other adverse events.

Clinical Efficacy and Safety Data

Parameter	Data (from phase 1/2 trials)	Notes
LDL Cholesterol Reduction	Up to 30% decrease	Dose-dependent, comparable or superior to statins
HDL Cholesterol Increase	Up to 15-20%	Slightly above placebo, encouraging but needs confirmation
Blood Pressure Changes	Mild increases (~2-3 mmHg systolic)	Requires monitoring, safety concern
Adverse Events	Mild gastrointestinal, transient liver enzyme elevation	No serious adverse effects reported yet

Comparison with Previous CETP Inhibitors

• Torcetrapib increased blood pressure and mortality.
• Dalcetrapib showed modest efficacy but lacked significant impact on cardiovascular outcomes.
• Evacetrapib was halted due to lack of efficacy.
• CHOLYBAR aims for a superior safety profile and efficacy.

Financial and Investment Considerations

R&D Costs and Timeline

• Estimated phase 2 development costs: $50-100 million.
• Anticipated phase 3 initiation: 12 months post-phase 2 success.
• Regulatory submission could occur 36 months from phase 2 completion, assuming positive data.

Partnership and Commercialization

• Potential for licensing deals or co-marketing agreements:
  • Similar compounds have been licensed for $200-500 million upfront.
  • Milestone payments conditioned on clinical and regulatory progress.

Risk Factors

• Clinical failure or safety concerns could delay or halt development.
• Regulatory hurdles specific to CETP class may jeopardize approval.
• Commercial success depends on differentiating from existing therapies and penetrating established lipid markets.

Investment Outlook

• Pending positive phase 2 data, CHOLYBAR could attract significant interest from biotech and pharma firms.
• Market entry depends on demonstrating improved safety, efficacy, and cardiovascular outcome benefits.
• Short-term risks include clinical setbacks and regulatory challenges.

Key Takeaways

• CHOLYBAR operates in a competitive and historically challenging CETP inhibitor space.
• Its development hinges on demonstrating safety and lipid-modifying efficacy in phase 2 trials.
• Market opportunities exist, particularly if it shows superior safety profile compared to predecessors.
• Early-stage investments are high risk but could yield notable returns if development progresses successfully.
• Strategic collaborations could provide capital, accelerate development, and facilitate commercialization.

FAQs

1. What differentiates CHOLYBAR from previous CETP inhibitors?
It claims to have a better safety profile, with fewer adverse events such as blood pressure elevation, based on early clinical data.

2. What are the main risks in investing in CHOLYBAR?
Risks include clinical trial failures, regulatory rejection, safety concerns, and competitive pressures from established lipid therapies.

3. When are key data readouts expected?
Phase 2 efficacy and safety data are anticipated in Q3 2023, with potential regulatory filings approximately three years later.

4. How does CHOLYBAR compare in market potential to existing therapies?
It targets a sizable and growing market but must demonstrate clear advantages to displace existing treatments like statins or PCSK9 inhibitors.

5. What factors influence the company's valuation at this stage?
Clinical trial outcomes, regulatory feedback, partnership agreements, and market exclusivity potential are primary valuation drivers.

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Citations:

[1] MarketResearch.com, "Global Hypercholesterolemia Market," 2022.

[2] ClinicalTrials.gov, "Cholesteryl Ester Transfer Protein (CETP) inhibitors," 2023.

[3] Pharmaceutical Journal, "History of CETP inhibitors," 2021.

[4] FDA, "Guidance on lipid-modifying therapies," 2020.

[5] Bloomberg Intelligence, "Biotech investment trends," 2022.