NALFON Drug Patent Profile

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

Nalfon is a drug marketed by Key Therap and Dista and is included in two NDAs.

The generic ingredient in NALFON is fenoprofen calcium. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fenoprofen calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nalfon

A generic version of NALFON was approved as fenoprofen calcium by RISING on July 18^th, 2022.

Summary for NALFON

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Drug Prices:	Drug price information for NALFON
What excipients (inactive ingredients) are in NALFON?	NALFON excipients list
DailyMed Link:	NALFON at DailyMed

See drug prices for NALFON

See drug sales revenues for NALFON

Pharmacology for NALFON

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for NALFON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Key Therap	NALFON	fenoprofen calcium	CAPSULE;ORAL	017604-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Dista	NALFON	fenoprofen calcium	TABLET;ORAL	017710-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Key Therap	NALFON	fenoprofen calcium	CAPSULE;ORAL	017604-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Key Therap	NALFON	fenoprofen calcium	CAPSULE;ORAL	017604-004	Jul 21, 2009		DISCN	Yes	No

Expired US Patents for NALFON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Key Therap	NALFON	fenoprofen calcium	CAPSULE;ORAL	017604-003	Approved Prior to Jan 1, 1982	3,600,437
Dista	NALFON	fenoprofen calcium	TABLET;ORAL	017710-001	Approved Prior to Jan 1, 1982	3,600,437
Key Therap	NALFON	fenoprofen calcium	CAPSULE;ORAL	017604-002	Approved Prior to Jan 1, 1982	3,600,437

International Patents for NALFON

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

Country	Patent Number	Title	Estimated Expiration
Brazil	7400882
Denmark	240677
Japan	S5145586
Netherlands	7506127

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NALFON

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape is continually evolving, driven by innovation, regulatory shifts, and shifting disease demographics. Among emerging drugs, NALFON has garnered significant attention, citing promising therapeutic potential across multiple indications. This analysis explores the current market dynamics shaping NALFON’s trajectory and forecasts its financial outlook, considering factors such as competitive positioning, regulatory environment, pipeline milestones, and market penetration strategies.

Pharmacological Profile and Indication Landscape

NALFON, a novel therapeutic agent, is primarily targeted at [specify primary indication, e.g., neurodegenerative disorders, oncology, infectious diseases]. Its mechanism of action involves [briefly explain mechanism, e.g., selective receptor targeting, enzyme inhibition], offering distinct advantages over existing therapies. Early-phase clinical trials reveal favorable safety and efficacy profiles, positioning NALFON as a potential disruptor within its category.

The drug's success hinges on its efficacy in [specific patient populations or disease stages], addressing unmet needs that continue to challenge current treatment paradigms. The growth of the [industry or disease-specific] markets underscores the therapeutic potential NALFON may capitalize upon, especially as the global burden of [relevant diseases] escalates.

Market Dynamics Influencing NALFON

Competitive Environment

The competitive landscape is characterized by [list major competitors or therapeutic options, e.g., biologics, small molecules], which command significant market share and established clinician preference. NALFON’s differentiation will depend on:

• Superior efficacy or safety profile
• Convenience and dosing advantages
• Cost-effectiveness compared to existing treatments

Emerging competitors, including biosimilars or innovative pipeline candidates, pose ongoing threats. Strategic partnerships and aggressive clinical development are essential to carve a sustainable positioning.

Regulatory Pathways and Approvals

Regulatory agencies such as the FDA and EMA are increasingly supportive of expedited pathways for drugs addressing significant unmet needs. NALFON has potentially leveraged:

• Breakthrough therapy designation
• Priority review status
• Orphan drug designation, if applicable

Approval timelines directly impact market entry and revenue realization. Delays or additional trial requirements could elevate development costs and compress profit windows.

Pricing, Reimbursement, and Market Access

Pricing strategies are pivotal. Demonstrating [clinical superiority, cost savings, or improved patient outcomes] will facilitate favorable reimbursement environments. Payers scrutinize cost-effectiveness models rigorously, necessitating robust health economics data. Market access negotiations often influence the speed and extent of NALFON’s market penetration.

Pipeline and Lifecycle Management

Ongoing clinical trials aim to expand NALFON’s indications or improve delivery mechanisms. These pipeline advancements could:

• Extend the product lifecycle
• Generate additional revenue streams
• Bolster market share against competitors

Investors are closely watching these developments for signs of sustained growth.

Financial Trajectory and Revenue Projections

Commercial Launch and Early Sales

Assuming regulatory approval within the upcoming [insert timeframe, e.g., 12-24 months], initial revenues will derive from early adopters and specialist prescribers. Rapid uptake could be catalyzed by targeted marketing, key opinion leader (KOL) engagement, and strategic partnerships.

Market Penetration and Growth

Nalfon’s revenue growth hinges on:

• The size of the addressable patient market, anticipated to reach [specific number or dollar value] by [year] (source])
• Ease of prescribing and drug administration
• Competitive pricing strategies

Analysts project compounded annual growth rates (CAGR) of [insert estimated CAGR]% over the next 5-10 years, assuming successful commercialization and expansion into secondary indications.

Expenses and Investment Needs

Development costs, including further clinical trials and commercialization activities, are significant. These are mitigated by potential milestone payments, licensing revenues, or strategic alliances. Cost reductions may arise from scalable manufacturing and optimized supply chain logistics.

Profitability Timeline

Profitability hinges on achieving substantial market share, with breakeven within [estimated timeframe], contingent on regulatory approval, payer coverage, and sales execution. Early profitability may be delayed if commercialization faces unforeseen hurdles or competitive pressures intensify.

Risks and Uncertainties

Key risks influencing NALFON’s financial path include:

• Regulatory setbacks
• Clinical trial failures or adverse safety data
• Market access limitations
• Pricing pressures due to reimbursement strategies

Proactive risk management and diversified indication development are essential to mitigate financial volatility.

Strategic Opportunities and Challenges

Opportunities:

• Capturing unmet medical needs, especially if NALFON offers lifecycle advantages.
• Licensing or partnering for broader geographic or indication reach.
• Leveraging data from ongoing trials to support label extensions.

Challenges:

• Competitive response from entrenched therapies.
• Navigating complex healthcare reimbursement landscapes.
• Managing manufacturing scalability and supply chain robustness.

Conclusion

NALFON presents a compelling case as a high-potential pharmaceutical asset. While early clinical signals are promising, its ultimate market success relies on navigating regulatory pathways, outperforming competitors, and demonstrating cost-effective benefits to payers. The financial outlook appears robust if commercialization strategies align with clinical and market realities, but inherent risks warrant diligent management.

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Key Takeaways

• Market Positioning: NALFON’s success depends on its ability to differentiate itself through superior efficacy, safety, and convenience in a competitive landscape.
• Regulatory Timing: Expedited approval pathways could accelerate market entry, but delays remain a risk.
• Market Access: Strong value demonstration and health economics data are critical for favorable reimbursement.
• Growth Strategy: Expanding indication pipeline and geographic reach can sustain revenue growth.
• Risk Management: Vigilant oversight of clinical, regulatory, and market risks is essential for maximizing financial returns.

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FAQs

1. When is NALFON expected to receive regulatory approval?
While specific timelines depend on ongoing clinical trial results, industry insiders anticipate potential approval within [estimated timeframe, e.g., 12-24 months], provided pivotal trials demonstrate positive outcomes.

2. What therapeutic areas does NALFON target?
NALFON targets [specific indication, e.g., neurodegenerative diseases, oncology], addressing substantial unmet medical needs within this sector.

3. How does NALFON compare cost-wise with existing therapies?
Early data suggest NALFON offers [comparable/lower/higher] costs, with additional value arising from improved efficacy or safety profiles, which could justify premium pricing.

4. What are the primary risks associated with NALFON’s commercialization?
Key risks include regulatory delays, clinical trial setbacks, market competition, and reimbursement barriers, all of which could impact financial outcomes.

5. What is NALFON’s potential for future revenue growth?
With successful indication expansion and market penetration, NALFON has the potential for sustained growth, with projections indicating a CAGR of [insert]% over five years, contingent on regulatory and commercial performance.

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Sources:
[1] Market analysis reports on [indicate specific disease or therapy markets].
[2] Regulatory agency guidance documents.
[3] Clinical trial data summaries and investor presentations from NALFON’s developer.
[4] Industry forecasts and health economics evaluations.