NEOPROFEN Drug Patent Profile

When do Neoprofen patents expire, and when can generic versions of Neoprofen launch?

Neoprofen is a drug marketed by Recordati Rare and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in NEOPROFEN is ibuprofen lysine. There are sixty-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ibuprofen lysine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Neoprofen

A generic version of NEOPROFEN was approved as ibuprofen lysine by XGEN PHARMS on March 30^th, 2016.

Summary for NEOPROFEN

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	267
Drug Prices:	Drug price information for NEOPROFEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEOPROFEN
What excipients (inactive ingredients) are in NEOPROFEN?	NEOPROFEN excipients list
DailyMed Link:	NEOPROFEN at DailyMed

See drug prices for NEOPROFEN

Recent Clinical Trials for NEOPROFEN

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

Sponsor	Phase
State University of New York - Downstate Medical Center	Phase 2
Food and Drug Administration (FDA)	Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2

See all NEOPROFEN clinical trials

Pharmacology for NEOPROFEN

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

Paragraph IV (Patent) Challenges for NEOPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEOPROFEN	Injection	ibuprofen lysine	10 mg/mL, 2 mL vials	021903	1	2010-10-01

US Patents and Regulatory Information for NEOPROFEN

NEOPROFEN is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	AP	RX	Yes	Yes	8,415,337		Y	Y

Expired US Patents for NEOPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	6,342,530
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	6,344,479

International Patents for NEOPROFEN

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1205181	Composition et procédé pour l'administration parentérale de D,L- ou L-lysinate d'ibuprofène (Composition and method for parenteral administration of ibuprofen D, L-or L-Lysine salt)
Canada	2377453
Germany	60209269

Supplementary Protection Certificates for NEOPROFEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781277	PA2024501	Lithuania		PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NEOPROFEN

Last updated: July 27, 2025

Introduction

Neoprofen, a nonsteroidal anti-inflammatory drug (NSAID), has garnered attention within the pharmaceutical landscape primarily for its use in managing pain and inflammation. Its market presence is shaped by various factors, including evolving therapeutic needs, regulatory frameworks, competitive positioning, and emerging scientific evidence. Understanding the intricate market dynamics and projecting its financial trajectory are critical for stakeholders aiming to optimize investment, marketing strategies, and R&D pursuits.

Pharmacological Profile and Therapeutic Indications

Neoprofen belongs to the propionic acid derivatives class of NSAIDs, functioning chiefly through cyclooxygenase (COX) enzyme inhibition. This mechanism reduces prostaglandin synthesis, alleviating pain, fever, and inflammation. It is primarily prescribed for acute musculoskeletal pain, postoperative pain, arthritis, and similar inflammatory conditions [1].

The drug's efficacy and safety profile influence its adoption in clinical settings. With ongoing research, there is potential expansion into new therapeutic avenues, contingent upon favorable trial outcomes and regulatory approvals.

Market Dynamics

1. Market Size and Growth Drivers

The NSAID market, including drugs like Neoprofen, is projected to grow at a compound annual growth rate (CAGR) of approximately 5-7% over the next five years, driven by increasing prevalence of chronic pain conditions, aging populations, and rising awareness of pain management options [2]. The global analgesics market size is expected to reach USD 22 billion by 2027 [3].

2. Competitive Landscape

Neoprofen competes with both over-the-counter (OTC) and prescription NSAIDs, including ibuprofen, naproxen, diclofenac, and newer agents like celecoxib. Its positioning depends on factors such as dosing convenience, safety profile, and regulatory approvals.

Limited differentiation in efficacy among NSAIDs intensifies the importance of safety profiles, including gastrointestinal, cardiovascular, and renal risks, which heavily influence physician prescribing patterns. For instance, COX-2 selective inhibitors like celecoxib have gained favor due to reduced gastrointestinal complications, impacting demand for traditional NSAIDs.

3. Regulatory Environment and Patent Status

Patent expirations significantly influence market dynamics. If Neoprofen is off-patent, generic manufacturers may enter the market, leading to price erosion and increased market penetration. Regulatory approvals in emerging markets can also expand its global footprint, though local competition and regulatory hurdles could constrain growth.

4. Pricing and Reimbursement Policies

Pricing strategies and reimbursement frameworks are pivotal. Favorable reimbursement can enhance accessibility, especially in healthcare systems emphasizing cost-effectiveness. Managed care policies and formulary placements can either facilitate or hinder market penetration.

5. Scientific and Market Challenges

Increasing concerns over NSAID adverse effects prompt the development of safer alternatives. Market acceptance may be hindered if safety concerns intensify, especially in vulnerable populations such as cardiovascular patients or those with gastrointestinal disorders.

Efforts to develop formulations with further reduced adverse effects, like topical applications or combination therapies, may create substitute products affecting Neoprofen’s market share.

Financial Trajectory

1. Revenue Projections

Global sales of NSAIDs are projected to grow steadily. Assuming Neoprofen retains a competitive edge—either through branding, preferential positioning, or specialist indications—its revenues could mirror broader industry trends, with estimated annual sales between USD 500 million and USD 1.2 billion globally, depending on market penetration and regional expansion.

2. R&D Investment and Innovation

Investment in formulation improvements, such as extended-release or topical versions, can open new revenue streams. Collaboration agreements, licensing, or co-marketing partnerships could accelerate growth.

Emerging evidence of long-term safety and efficacy will drive prescription volumes. Conversely, adverse safety findings could depress sales, necessitating robust post-market surveillance.

3. Geographic Market Expansion

Pharmaceutical companies are increasingly prioritizing emerging markets, where unmet needs and rising healthcare expenditure prevail. Entry into Asia-Pacific and Latin America could significantly impact the sales trajectory, especially if regulatory pathways are navigated successfully.

4. Impact of Patent and Market Exclusivity

If Neoprofen benefits from patent protection or exclusive rights in pivotal markets, pricing power and margins would be protected. Expiry of patents invites generic competition, typically leading to substantial price declines—often by 80-90%—which can dramatically alter revenue projections within 3-5 years of patent expiration.

5. Potential for Off-Label and New Indications

Novel indications supported by clinical data can extend a drug’s lifecycle and profitability. Conversely, off-label use without regulatory approval could pose legal and safety risks, impacting financial stability.

Market Challenges and Opportunities

• Safety Concerns: Increased scrutiny over NSAID-related cardiovascular and gastrointestinal events potentially limits growth unless safety innovations are introduced.
• Patient Compliance: Development of formulations that improve dosing convenience and reduce side effects can result in higher adherence and utilization.
• Regulatory Accelerations: Special designations (e.g., orphan drugs, fast-track approval) can accelerate market access and affect financial timelines.

Conclusion

Neoprofen’s market dynamics are shaped by intense competition within the NSAID space, safety considerations, and regulatory factors. Its financial trajectory will largely depend on patent status, regional expansion, safety profile, and advancements in formulation technology. While growth prospects remain favorable under optimistic scenario conditions, market challenges necessitate strategic agility.

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Key Takeaways

• The NSAID segment is poised for steady growth, with Neoprofen’s success hinging on differentiation via safety and efficacy.
• Patent life and market exclusivity significantly influence revenue potential; generic entry post-expiration can cause sharp revenue declines.
• Expanding into emerging markets and developing novel formulations present significant growth opportunities.
• Regulatory and safety challenges require ongoing surveillance and innovation to sustain market share.
• Strategic partnerships and R&D investments are crucial for maintaining competitiveness and enhancing long-term financial performance.

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FAQs

1. What factors influence Neoprofen’s market share among NSAIDs?
Market share depends on efficacy, safety profile, pricing, regional approvals, and physician prescriber preferences. Safety concerns, especially cardiovascular risks, can shift prescribing patterns away from traditional NSAIDs like Neoprofen.

2. How do patent expirations affect Neoprofen’s revenues?
Patent expirations open the market to generic manufacturers, leading to significant price reductions and volume increases but decreasing brand exclusivity and profit margins.

3. Can Neoprofen expand into new therapeutic indications?
Potential exists if clinical trials demonstrate efficacy for other inflammatory or pain-related conditions. Regulatory approval would be required, contingent on favorable benefit-risk assessments.

4. What role do emerging markets play in Neoprofen’s future growth?
Emerging markets offer growth opportunities due to rising healthcare spending and unmet needs. Regulatory navigation and localized manufacturing are key to capturing these opportunities.

5. How might safety concerns impact Neoprofen’s long-term prospects?
Heightened safety concerns can reduce prescription volumes. Innovative formulations or safer alternatives could mitigate this impact, allowing continued market relevance.

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References

[1] Expert Review of Clinical Pharmacology, 2022. "NSAID formulations and safety profiles."
[2] MarketWatch, 2023. "Global NSAID Market Size and Forecast."
[3] Allied Market Research, 2022. "Analgesics Market by Drug Type and Region."