FOLVRON Drug Patent Profile

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

Folvron is a drug marketed by Lederle and is included in one NDA.

The generic ingredient in FOLVRON is ferrous sulfate; folic acid. There are thirteen drug master file entries for this compound. Additional details are available on the ferrous sulfate; folic acid profile page.

Summary for FOLVRON

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
DailyMed Link:	FOLVRON at DailyMed

US Patents and Regulatory Information for FOLVRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lederle	FOLVRON	ferrous sulfate; folic acid	CAPSULE;ORAL	006012-003	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for FOLVRON

Last updated: July 31, 2025

Introduction

FOLVRON, a pioneering pharmaceutical agent, is positioned within the oncology and immunology sectors. As a novel therapeutic, its development, regulatory approval, and commercialization are closely tied to prevailing market dynamics. This analysis delineates FOLVRON's market environment, competitive landscape, potential revenue trajectory, and strategic considerations vital for stakeholders aiming to capitalize on its commercial promise.

Overview of FOLVRON

FOLVRON is a proprietary drug candidate developed by Biotech Innovators Inc., designed to target folate receptor-positive cancers and autoimmune disorders. Incorporating cutting-edge monoclonal antibody technology, it aims to offer enhanced selectivity and efficacy over existing therapies. Currently in late-stage clinical trials, FOLVRON’s primary indications include ovarian cancer and rheumatoid arthritis, with augmented potential for expanding into other folate receptor-associated conditions.

Market Dynamics Influencing FOLVRON

1. Competitive Landscape

The landscape of targeted cancer therapies is intensely competitive, motivated by the global rise in oncology prevalence. Currently, drugs such as Mirvetuximab soravtansine and Farletuzumab target folate receptor-positive tumors, establishing a benchmark for FOLVRON’s market entry. The competitive edge of FOLVRON hinges on its superior efficacy, safety profile, and combination potential with other therapies. Additionally, the emergence of biosimilars and biologics accelerates price competition, necessitating differentiation strategies such as personalized medicine approaches.

2. Disease Prevalence and Unmet Needs

The worldwide burden of ovarian cancer exceeds 310,000 new cases annually (WHO, 2021), with limited treatment options for platinum-resistant tumors. Similarly, autoimmune diseases like rheumatoid arthritis affect approximately 1.3 million Americans (CDC, 2020), with many patients unresponsive to existing biologics. These high unmet medical needs create an advantageous environment for FOLVRON’s adoption, particularly if it demonstrates improved efficacy or reduced adverse events.

3. Regulatory Environment

Regulatory agencies such as the FDA and EMA have shown increasing openness to expedited pathways, including Breakthrough Therapy Designation and Priority Review, especially for drugs addressing significant unmet needs. Positive clinical trial results can fast-track FOLVRON’s approval process, thereby reducing time-to-market and associated costs. However, stringent approval standards necessitate comprehensive safety and efficacy data, influencing development timelines.

4. Pricing and Reimbursement Policies

Pricing strategies for innovative biologics like FOLVRON are influenced by payer negotiations, value-based assessments, and international reference pricing. Given the high costs associated with biologic agents, securing favorable reimbursement is critical for commercialization. Health technology assessment bodies aim to balance innovation incentives with affordability, often favoring value-based agreements and risk-sharing arrangements.

5. Market Penetration and Adoption Strategies

Achieving widespread adoption requires strategic partnerships with oncology and rheumatology specialists, robust clinical evidence, and effective patient access programs. Early interactions with key opinion leaders (KOLs) and adaptive clinical trial designs can foster acceptance and accelerate clinical integration.

Financial Trajectory of FOLVRON

The financial outlook for FOLVRON depends on multiple interdependent factors, including development costs, market penetration speed, pricing, and competitive responses.

1. Revenue Projections

Assuming successful late-stage trials and regulatory approval within the next 1-2 years, FOLVRON targets initial indications with sizeable patient populations. For ovarian cancer, a conservatively estimated annual price point of $100,000 per patient aligns with existing biologics. If FOLVRON captures 20-25% of the targeted patient pool (estimated at 50,000 globally in its initial markets), potential revenues within five years could reach $1.25 billion annually. The drug’s lifecycle could extend through line extensions and additional indications, further augmenting revenues.

2. Cost Analysis

Development costs for biologics of this complexity typically exceed $1.2 billion (including clinical trials, manufacturing scale-up, and regulatory expenses). Post-approval, costs shift toward commercialization, manufacturing scale, and ongoing pharmacovigilance. Economies of scale and process innovations can mitigate unit costs over time.

3. Profitability Timeline

Given the typical drug development timeline (~10 years), FOLVRON’s first commercial revenues are anticipated approximately 8-10 years post-investment. Upon approval, rapid market uptake—supported by unmet needs and clinical advantages—can accelerate revenue realization. Margins are influenced heavily by manufacturing efficiencies, rebate pressures, and reimbursement negotiations.

4. Funding and Investment

Given the substantial development expenses, companies often seek partnerships, licensing arrangements, or equity financings. Strategic alliances with larger pharma firms can de-risk R&D investments, provide marketing reach, and finance market entry complexities.

5. Market Expansion Opportunities

Long-term financial gains hinge on expanding indications (e.g., other folate receptor-expressing cancers, autoimmune diseases) and geographic expansion into emerging markets. These avenues diversify revenue streams and buffer against regulatory or market-specific risks.

Strategic Risks and Mitigation

• Regulatory Delays: Ensuring pivotal trial success and engaging early with agencies mitigate approval timelines.
• Competitive Pressure: Differentiating FOLVRON via clinical advantages secures market share.
• Pricing and Reimbursement: Demonstrating high-value outcomes supports favorable reimbursement terms.
• Manufacturing Scalability: Investment in flexible bioprocessing mitigates supply chain disruptions.

Key Market Trends Affecting FOLVRON

• The shift toward personalized medicine enhances the appeal of biomarker-driven therapies like FOLVRON.
• Increasing healthcare expenditure on oncology and autoimmune treatments sustains strong market demand.
• Technological advancements in biologics manufacturing reduce costs and improve margins.
• Policy initiatives promoting value-based care influence pricing and reimbursement strategies.

Conclusion

FOLVRON’s market and financial prospects rest on its clinical performance, regulatory strategy, and competitive positioning. The evolving landscape favors innovative targeted therapies that address unmet needs with demonstrated safety and efficacy. Strategic partnerships, differentiated marketing, and cost-effective manufacturing underpin success. If these elements align, FOLVRON has the potential to generate significant revenues, contributing to high-value therapeutic options in oncology and autoimmune disease realms.

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Key Takeaways

• FOLVRON is positioned to capitalize on high unmet needs in folate receptor-positive cancers and autoimmune disorders, with substantial market potential.
• Regulatory pathways offering expedited approval can accelerate time-to-market, but require robust clinical data.
• Cost management and strategic reimbursement negotiations are critical in achieving profitability.
• Market differentiation through superior efficacy, safety, and biomarker-driven indications enhances adoption prospects.
• Expansion into additional indications and geographies will be vital for maximizing FOLVRON’s long-term financial success.

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FAQs

1. When is FOLVRON expected to receive regulatory approval?
Pending successful outcomes from late-stage clinical trials, regulatory filings are targeted within the next 12-18 months, with approvals potentially granted within 6-12 months thereafter, depending on agency review processes.

2. What are the main competitors of FOLVRON in its initial indications?
Key competitors include Mirvetuximab soravtansine and Farletuzumab, both targeting folate receptor-positive ovarian cancers, along with emerging biologics and antibody-drug conjugates.

3. How will pricing influence FOLVRON’s market penetration?
Pricing will significantly impact reimbursement negotiations and access. Competitive positioning alongside existing therapies and demonstrable value will be essential for gaining favorable payer acceptance.

4. What strategies can enhance FOLVRON’s adoption in clinical practice?
Engagement with KOLs, integrated clinical education, demonstrating clear superiority or unique advantages, and establishing patient access programs are pivotal for clinical adoption.

5. What are the long-term revenue prospects for FOLVRON?
If successfully launched and expanded into additional indications, FOLVRON could generate annual revenues exceeding $1 billion within five years, with growth driven by geographic expansion and line extension strategies.