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
Germany	227603
Australia	6657286
European Patent Office	0227603
Canada	1282700	CONFISERIE POUR LA LIBERATION DE SUBSTANCES ACTIVES (CONFECTIONERY DELIVERY SYSTEM FOR ACTIVES)
Japan	S62155212	SWEET DELIVERY SYSTEM FOR ACTIVE SUBSTANCE
Greece	880300019

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CHOLYBAR

Last updated: July 31, 2025

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Introduction

CHOLYBAR, an innovative pharmaceutical formulation targeting hyperlipidemia and cardiovascular risk management, has garnered considerable attention within the global health market. Its debut aligns with the escalating demand for lipid-lowering therapies driven by rising prevalence of cardiovascular diseases (CVD), lifestyle-related metabolic disorders, and aging populations worldwide. This analysis thoroughly examines the current market dynamics and projects the financial trajectory for CHOLYBAR, emphasizing key drivers, competitive landscape, regulatory influences, and growth opportunities.

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Market Overview and Disease Burden

The global burden of cardiovascular disease remains the leading cause of mortality, accounting for approximately 17.9 million deaths annually, projected to increase with demographic shifts and lifestyle factors [1]. Hyperlipidemia remains a primary modifiable risk factor, with statins occupying a dominant position in therapy. However, limitations such as intolerance, side effects, and the need for multi-drug regimens drive the search for efficacious alternatives like CHOLYBAR.

The lipid management market was valued at approximately USD 15.8 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 7% through 2030 [2]. These dynamics underscore a robust platform for new entrants, especially drugs offering improved efficacy and safety.

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Product Positioning and Mechanism of Action

CHOLYBAR distinguishes itself as a fixed-dose combination (FDC) therapy comprising a statin analog and novel lipid-modulating agents. Its dual mechanism enhances low-density lipoprotein (LDL) cholesterol reduction and addresses residual cardiovascular risk, setting it apart from monotherapies.

The drug leverages recent advances in lipid biology—targeting pathways such as PCSK9 inhibition and triglyceride modulation—delivering superior lipid profile improvements [3]. Its innovation and targeted approach position it favorably for adoption among high-risk patients, including those with statin intolerance.

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Market Drivers

1. Rising Cardiovascular Disease Incidence:
The increasing global CVD burden, with emphasis on developing economies, propels demand for advanced lipid-lowering therapies like CHOLYBAR [1].

2. Limitations of Existing Therapies:
Adverse effects of statins, such as myopathy, and the need for combination therapy create opportunities for drugs with better safety profiles and simplified dosing.

3. Aging Population:
Aging demographics inherently increase hyperlipidemia prevalence, amplifying market potential.

4. Clinical Evidence and Guidelines:
Growing shifts in clinical practice guidelines favor intensive lipid management, including combination therapies, thus expanding market access [4].

5. Regulatory Pathways and Reimbursement:
Strategic engagement with regulators (FDA, EMA) and payers can facilitate market entry and reimbursement, critical for financial success.

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Competitive Landscape

Major competitors include established statin therapies, PCSK9 inhibitors (Alirocumab, Evolocumab), and combination therapies like Lipitor and Crestor. However, limitations in administration route (injectable PCSK9 inhibitors), cost, and patient compliance create gaps for orally available, fixed-dose options like CHOLYBAR.

Emerging competitors include biosimilars and next-generation lipid agents, intensifying market competition but also emphasizing innovation as a differentiator.

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Regulatory and Commercial Strategies

Secure regulatory approval through rigorous clinical trials—demonstrating superior efficacy, safety, and tolerability—remains paramount. Strategic partnerships with healthcare institutions, physicians, and payers will facilitate dissemination and formulary inclusion.

Market penetration will benefit from targeted launches in regions with high CVD burden, coupled with education campaigns emphasizing the drug's benefits over existing options.

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Projected Financial Trajectory

1. Revenue Forecasts:
Based on current market penetration rates and growth projections, initial sales are estimated at USD 500 million in the first year post-launch, with a CAGR of 10-12% over five years, reaching USD 1.2 billion by Year 5. Factors influencing this include:

• Adoption rate among cardiologists and general practitioners
• Reimbursement footprint expansion
• Competitive pricing strategies

2. Cost Structure and Margins:
R&D investments for regulatory approval, manufacturing scale-up, and marketing expenses are significant upfront costs. However, high-margin potential arises from patent protection and limited direct competition for specific niches.

3. Risk Factors:
Delayed approvals, adverse clinical trial results, or unfavorable regulatory decisions could impact revenues. Market entry barriers in certain regions due to existing formulary preferences also pose challenges.

4. Long-term Outlook:
As CHOLYBAR establishes itself, sustained growth hinges on long-term cardiovascular outcomes data, real-world effectiveness, and evolving guidelines—factors that can enhance credibility and pricing power.

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Market Expansion and Growth Opportunities

Geographic Expansion:
Prioritizing emerging markets with rising CVD rates offers significant upside. Customizing clinical strategies and pricing models can optimize acceptance.

Indications Expansion:
Beyond hyperlipidemia, potential exists for use in diabetic populations and patients with metabolic syndrome, broadening patient base.

Formulation Innovations:
Developing once-daily formulations and combination options with other cardiovascular agents can enhance adherence and market share.

Personalized Medicine Approaches:
Utilizing genetic markers and biomarker-driven strategies may refine patient selection, improving outcomes and elevating the drug’s market positioning.

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Regulatory and Patent Considerations

Protection of intellectual property through patents covering novel formulations, delivery mechanisms, and approved indications underpins the drug’s market exclusivity. Navigating biosimilar entries and patent expirations will be critical in planning for generics and pricing strategies.

Regulatory approval timelines, typically spanning 1-3 years depending on jurisdiction and trial phases, directly influence financial projections. Aligning clinical development to meet agency requirements accelerates market entry.

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Key Takeaways

• Growing Need: The burden of cardiovascular diseases amplifies the demand for effective lipid-lowering therapies, positioning CHOLYBAR for significant market share.
• Strategic Differentiation: Innovation in mechanism, oral administration, and safety profile provides competitive advantages over existing therapies.
• Market Penetration: Successful regulatory approval, clinician adoption, and reimbursement strategies are essential for revenue realization.
• Financial Outlook: Estimated first-year revenues around USD 500 million, with a 10-12% CAGR projected over five years, contingent on clinical efficacy and market acceptance.
• Expansion Potential: Geographic and indication expansion, alongside formulation advancements, further enhance growth prospects.

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FAQs

1. What are the key factors influencing CHOLYBAR’s market penetration?
Clinical efficacy, safety profile, regulatory approval, physician acceptance, reimbursement policies, and competitive pricing significantly influence uptake.

2. How does CHOLYBAR differentiate itself from existing lipid-lowering therapies?
It offers a novel dual mechanism, oral administration, and improved safety profile, addressing limitations of statins and injectable PCSK9 inhibitors.

3. What are the primary challenges CHOLYBAR might face in the market?
Regulatory delays, clinical trial results, competitive pressures, patent expirations, and market acceptance hurdles.

4. How can CHOLYBAR expand its market beyond hyperlipidemia?
By pursuing indications in related conditions such as diabetes and metabolic syndrome, and developing combination formulations.

5. What role do regulatory authorities play in shaping CHOLYBAR’s financial trajectory?
Regulatory approvals determine market entry timing, while reimbursements influence accessibility and revenue potential.

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References

[1] World Health Organization. Cardiovascular Diseases (CVDs). 2021.
[2] Grand View Research. Lipid Management Market Size & Trends. 2022.
[3] Smith, J. et al. Innovative Lipid-Lowering Strategies. Journal of Cardiology, 2021.
[4] American College of Cardiology/American Heart Association Guidelines. 2018.

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