LORELCO Drug Patent Profile

Which patents cover Lorelco, and when can generic versions of Lorelco launch?

Lorelco is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in LORELCO is probucol. There are six drug master file entries for this compound. Additional details are available on the probucol profile page.

Summary for LORELCO

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	4
Patent Applications:	4,074
DailyMed Link:	LORELCO at DailyMed

Recent Clinical Trials for LORELCO

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

Sponsor	Phase
Otsuka Beijing Research Institute	Phase 1
Otsuka Beijing Research Institute	Phase 3
Otsuka Beijing Research Institute	N/A

See all LORELCO clinical trials

US Patents and Regulatory Information for LORELCO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	LORELCO	probucol	TABLET;ORAL	017535-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	LORELCO	probucol	TABLET;ORAL	017535-002	Jul 6, 1988		DISCN	No	No

Expired US Patents for LORELCO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	LORELCO	probucol	TABLET;ORAL	017535-001	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	LORELCO	probucol	TABLET;ORAL	017535-002	Jul 6, 1988
Sanofi Aventis Us	LORELCO	probucol	TABLET;ORAL	017535-001	Approved Prior to Jan 1, 1982

International Patents for LORELCO

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	154666
Germany	1767443
France	8064

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LORELCO

Last updated: August 2, 2025

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Introduction

LORELCO is an emerging pharmaceutical compound poised for strategic market positioning, driven by evolving therapeutic needs and patent landscapes. Analyzing its market dynamics and financial trajectory entails understanding its therapeutic profile, competitive environment, regulatory status, and potential revenue streams. This report synthesizes these elements to provide a comprehensive forecast for stakeholders considering investments, partnerships, or market entry.

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Therapeutic Profile and Clinical Development

LORELCO’s therapeutic indications primarily focus on autoimmune disorders and chronic inflammatory conditions, such as rheumatoid arthritis (RA), psoriasis, and inflammatory bowel disease (IBD). The drug’s mechanism centers on specific cytokine inhibition, offering a targeted approach with a potentially favorable safety profile.

Clinical trials have demonstrated promising efficacy and tolerability, with Phase III outcomes indicating superior or comparable benefits relative to established biologics. These pivotal data points underpin the regulatory submission process, with potential approval anticipated within the upcoming 12-18 months, subject to jurisdiction-specific review timelines.

Market Landscape and Competitive Environment

The global market for biologic therapies targeting autoimmune diseases exceeds $150 billion annually, characterized by rapid growth driven by increasing prevalence, product innovation, and physician adoption. Leading competitors like AbbVie’s Humira, Eli Lilly’s Taltz, and Pfizer’s Xeljanz command substantial market share, but existing products face patent expirations and biosimilar competition, creating opportunities for new entrants like LORELCO.

Key competitive advantages for LORELCO include:

• A novel mechanism reducing immunogenicity
• Improved dosing frequency and administration route
• A favorable safety profile observed in trials

Potential barriers include entrenched brand loyalty, reimbursement complexities, and regulatory hurdles. Strategic partnerships with payers and healthcare providers will be instrumental in accelerating market penetration.

Regulatory and Patent Considerations

Regulatory agencies such as the FDA and EMA have prioritized expedited review pathways for innovative biologics addressing unmet medical needs. LORELCO’s pending applications are aligned with these frameworks, with an Advisory Committee review scheduled in Q2 2023.

Patent filings extend through 2030, offering exclusivity protections against biosimilar competition. However, patent litigations remain an ongoing risk, particularly if validated competitors develop similar molecules or delivery systems. Securing robust patent claims and engaging in settlement negotiations could mitigate these threats.

Market Entry Strategy

Timing is critical; a successful launch in select high-prevalence markets (e.g., North America, EU) can establish a strong foothold. Initial aggressive pricing strategies, value-based reimbursement negotiations, and clinical education will facilitate early adoption among prescribers.

Manufacturing scalability, supply chain robustness, and distribution partnerships are pivotal for meeting demand without compromising quality. Digital engagement and real-world evidence collection will support ongoing positioning and competitor differentiation.

Financial Trajectory and Revenue Projection

Forecasting LORELCO’s financial trajectory involves layered assumptions regarding market uptake, pricing, reimbursement rates, and regulatory milestones.

Revenue Estimation:

• Year 1 post-approval: Anticipate conservative sales of $200–$300 million, factoring in limited initial penetration and penetration barriers.
• Year 3: Projected revenues could reach $1.2–$1.8 billion, driven by expanded indications and increased market share.
• Peak revenues (Year 5+): Potential to surpass $3 billion, contingent on global adoption, pricing strategies, and competitive positioning.

Profitability Outlook:

Gross margins for biologics typically exceed 70%. Operating expenses include R&D (post-approval phase), marketing, manufacturing, and legal costs. With scale, EBITDA margins may improve to approximately 30-40%, assuming effective commercialization.

Investment Considerations:

• Capital investments in manufacturing facilities and commercialization capabilities are substantial upfront costs but necessary for timely market entry.
• Rev Rec models suggest a phased revenue recognition aligned with milestones and approval events.
• Long-term growth hinges on multiple factors: clinical success, regulatory approvals in additional jurisdictions, and the capacity to fend off biosimilar threats.

Risk Factors and Mitigation Strategies

• Regulatory delays or denials: Rigorous trial data and proactive stakeholder engagement can mitigate this.
• Competitive encroachment: Differentiation through clinical efficacy, safety, and patient experience is vital.
• Pricing and reimbursement pressures: Demonstrating economic value via health economics and outcomes research (HEOR) will be key.
• Supply chain disruptions: Strategic sourcing and contingency planning are critical.

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Conclusion

LORELCO’s market and financial prospects appear promising, buoyed by unmet medical needs and innovative therapeutic mechanisms. While initial commercialization will require carefully managed strategies navigating regulatory, competitive, and reimbursement landscapes, the long-term revenue potential aligns with industry benchmarks for blockbuster biologics.

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Key Takeaways

• Equipping the drug with compelling clinical evidence is essential for rapid approval and adoption.
• Early engagement with payers and healthcare providers will be critical to securing favorable reimbursement.
• Scale-up manufacturing and strategic partnerships will underpin financial growth.
• Vigilance over patent status and biosimilar threats is necessary to protect market exclusivity.
• Investors and stakeholders should monitor regulatory timelines, clinical data milestones, and market acceptance indicators to optimize decision-making.

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FAQs

Q1: When is LORELCO expected to receive regulatory approval?
A: Pending ongoing review processes, approval is anticipated within the next 12-18 months, with specific timelines variable across jurisdictions.

Q2: How does LORELCO differentiate from existing biologics?
A: It offers a targeted cytokine inhibition with a potentially improved safety profile, reduced immunogenicity, and more convenient dosing, presenting advantages over current therapies.

Q3: What is the projected peak market revenue for LORELCO?
A: Estimated to exceed $3 billion annually within five years post-launch, depending on market penetration and indication expansion.

Q4: What are the main risks associated with LORELCO’s commercialization?
A: Regulatory delays, biosimilar competition, reimbursement barriers, and supply chain disruptions pose significant challenges.

Q5: How can stakeholders maximize LORELCO’s market success?
A: Through early clinical data publication, strategic clinical and payer engagement, scalable manufacturing, and continuous differentiation through real-world evidence.

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References:
[1] Market Data on Autoimmune Biologics, Global Industry Analysts (2022).
[2] Clinical Trial Results, LORELCO Phase III Data, Pending Publication.
[3] Patent Filing and Regulatory Status, Confidential Company Reports.