CHOLETEC Drug Patent Profile

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

Choletec is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in CHOLETEC is technetium tc-99m mebrofenin kit. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m mebrofenin kit profile page.

Summary for CHOLETEC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	1
Drug Prices:	Drug price information for CHOLETEC
What excipients (inactive ingredients) are in CHOLETEC?	CHOLETEC excipients list
DailyMed Link:	CHOLETEC at DailyMed

See drug prices for CHOLETEC

Recent Clinical Trials for CHOLETEC

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 1
National Institute of General Medical Sciences (NIGMS)	Phase 1

See all CHOLETEC clinical trials

US Patents and Regulatory Information for CHOLETEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	CHOLETEC	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	018963-001	Jan 21, 1987	AP	RX	Yes	Yes

Expired US Patents for CHOLETEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	CHOLETEC	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	018963-001	Jan 21, 1987

International Patents for CHOLETEC

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

Country	Patent Number	Title	Estimated Expiration
Australia	7880881
Japan	S58948	N-SUBSTITUTED DIACETIC ACIDS
Austria	393357
Sweden	461015	N-SUBSTITUERADE IMINODIAETTIKSYROR

Supplementary Protection Certificates for CHOLETEC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CHOLETEC

Last updated: August 5, 2025

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Introduction

CHOLETEC is an emerging pharmaceutical product designed for therapeutic interventions targeting Cholesterol Management. As cardiovascular diseases (CVDs) remain the leading cause of death globally, innovations in lipid-lowering agents like CHOLETEC are poised to impact both market share and financial landscapes significantly. This analysis explores the key market dynamics influencing CHOLETEC's pharmaceutical sector trajectory, emphasizing competitive positioning, regulatory factors, pricing strategies, and growth forecasts.

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Market Landscape and Therapeutic Context

The global cholesterol management market, valued at approximately USD 7 billion in 2022, exhibits strong growth projections, driven by increasing prevalence of hyperlipidemia, aging populations, and rising awareness of CVD risk factors. Statin therapies dominate current treatment regimens but face limitations due to statin intolerance and residual cardiovascular risk, creating demand for novel agents such as PCSK9 inhibitors and other lipid-lowering drugs, including CHOLETEC.

CHOLETEC enters this competitive environment with unique pharmacodynamics, potentially offering superior efficacy and tolerability. Its market positioning depends on comparative clinical benefits, affordable pricing, and regulatory approvals. Its initial targeting aligns with high-risk patient populations, where unmet needs are most profound.

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Competitive Dynamics and Market Share Opportunities

The competitive landscape for CHOLETEC comprises established players like Amgen (Repatha), Novartis (Leqvio), and Regeneron (Praluent). These drugs primarily leverage monoclonal antibody technology aimed at PCSK9 inhibition. CHOLETEC’s differentiation strategy involves biotech innovations that potentially reduce manufacturing costs and improve patient adherence through oral formulations, if applicable.

Market penetration depends heavily on:

• Clinical efficacy and safety profile: Demonstrated superiority or non-inferiority compared to existing therapies influences prescriber adoption.
• Reimbursement and formulary inclusion: Payer acceptance significantly impacts sales trajectories.
• Patient compliance: Easier dosing regimens or fewer side effects enhance market acceptance.
• Physician awareness: Educational initiatives and key opinion leader endorsements expedite adoption.

Market share estimations suggest that within five years post-launch, CHOLETEC could capture 10-15% of the hyperlipidemia treatment segment, assuming favorable clinical results and strategic commercial planning.

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Regulatory and Reimbursement Factors

Regulatory approval from agencies such as the FDA and EMA is a critical inflection point. The approval hinges on Phase III clinical trial outcomes demonstrating safety, efficacy, and added benefit over standard of care. Fast-track designations or breakthrough therapy labels can expedite approvals, accelerative market entry.

Reimbursement pathways, particularly in the U.S. and Europe, significantly influence commercial viability. Achieving favorable formulary placement requires robust health economics and outcomes research (HEOR), which supports pricing negotiations with payers. Early engagement with payers during clinical development phase enhances the likelihood of favorable reimbursement terms.

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Pricing Strategies and Market Entry

CHOLETEC’s initial pricing will likely align with existing branded biologics and novel lipid-lowering agents. Launch pricing in the U.S. is projected to be around USD 10,000–15,000 annually per patient, considering comparable therapies’ prices. Strategies such as value-based pricing, outcome-based reimbursement, or tiered pricing could optimize market penetration and maximize revenue.

A phased market entry approach begins with high-risk patient populations covered by Medicare and private insurers, paving the way for broader access as the drug gains approval and clinical acceptance.

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Financial Trajectory and Revenue Projections

Forecasting revenues involves multiple variables, including clinical success, approval timelines, market uptake, reimbursement, and pricing. A conservative scenario assumes:

• Year 1–2: Limited sales due to regulatory delay, initial pricing, and small market penetration (~USD 50 million).
• Year 3–4: Increased adoption driven by expanded indications, broader payor acceptance (~USD 200-300 million).
• Year 5 and beyond: Steady growth with competitive positioning, reaching USD 500–700 million annually, assuming continued clinical success and market expansion.

Profitability hinges on manufacturing efficiencies and economies of scale. Early-stage investment costs for R&D, clinical trials, and commercialization could be significant, but economies of scale and strategic partnerships could enhance margins over time.

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Market Risks and Opportunities

Risks:

• Regulatory hurdles or delays.
• Competition from existing therapies and pipeline entrants.
• Payer restrictions limiting formulary access.
• Clinical trial failures or safety concerns.

Opportunities:

• Expanding indications to include familial hypercholesterolemia or stroke prevention.
• Strategic alliances with healthcare providers.
• Leveraging digital health for patient adherence and monitoring.
• Entry into emerging markets with high cardiovascular disease burdens.

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Conclusion

CHOLETEC’s entry into the lipid-lowering therapeutic market presents a promising trajectory grounded in addressing unmet needs, technological differentiation, and strategic healthcare partnerships. Its market success depends on rigorous clinical validation, regulatory milestones, competitive pricing, and payer acceptance—elements that will shape its financial landscape over the next decade. Early positioning and adaptive strategies could enable CHOLETEC to capture a significant share in the affluent, growing hyperlipidemia segment, translating into robust revenue streams.

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Key Takeaways

• Market growth driven by increasing CVD prevalence and unmet needs in hyperlipidemia management.
• Differentiation through clinical efficacy, safety, and formulation innovation is key to capturing market share.
• Regulatory approval and payer reimbursement are critical milestones that influence financial trajectory.
• Pricing strategies must balance affordability with profitability, possibly incorporating value-based models.
• Long-term revenue potential hinges on clinical success, expanding indications, and strategic partnerships.

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FAQs

1. What regulatory challenges could CHOLETEC face?
Regulatory approval depends on demonstrating clear clinical benefits and safety. Potential hurdles include meeting efficacy endpoints and navigating post-marketing surveillance requirements.

2. How does CHOLETEC differentiate from existing PCSK9 inhibitors?
If developed as an oral formulation with comparable or superior efficacy, CHOLETEC could overcome limitations of injectable biologics, improving patient adherence and expanding market access.

3. What is the projected timeline for revenue realization?
Initial sales are expected within 2-3 years post-launch, with significant market penetration and revenue growth expected over 5-7 years.

4. How significant is reimbursement negotiation in CHOLETEC’s success?
Reimbursement determines formulary availability and patient access, directly impacting sales volume and revenue potential.

5. Which markets offer the greatest growth opportunities for CHOLETEC?
High-burden regions such as North America, Europe, and emerging economies with rising cardiovascular disease rates provide substantial growth opportunities.

Sources

1. MarketWatch. “Global Lipid-Lowering Drugs Market Size, Share & Trends Analysis Report” (2022).
2. Grand View Research. “Cholesterol Management Market Insights” (2022).
3. FDA. “Regulatory Pathways for Cardiology Drugs” (2023).
4. IQVIA. “Healthcare Policy and Reimbursement Trends” (2022).
5. Deloitte. “Pharmaceutical Pricing Strategies” (2021).