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
Food and Drug Administration (FDA)	Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2
State University of New York - Downstate Medical Center	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			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
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006

International Patents for NEOPROFEN

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

Country	Patent Number	Title	Estimated Expiration
Germany	60110185
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
Austria	318136

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 NEOPROFEN: An In-Depth Analysis

Last updated: December 27, 2025

Executive Summary

NEOPROFEN, a prominent non-steroidal anti-inflammatory drug (NSAID), has established itself within the analgesic and anti-inflammatory market segment. This report assesses the current market landscape, projected growth trajectories, competitive positioning, regulatory environment, and economic factors impacting NEOPROFEN’s financial outlook. By analyzing key drivers, challenges, and comparative data, stakeholders can better understand NEOPROFEN’s strategic prospects moving forward.

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What is NEOPROFEN?

NEOPROFEN is a proprietary formulation of ibuprofen designed to provide targeted pain relief and anti-inflammatory effects. Approved by regulatory authorities such as the FDA and EMA, NEOPROFEN is marketed for various indications including musculoskeletal pain, dental pain, and fever reduction. Its distinctive pharmacokinetic profile aims at enhanced bioavailability and reduced gastrointestinal side effects, setting it apart in a saturated OTC and prescription NSAID landscape.

Market Overview and Size

Global NSAID Market

• Valued at approximately USD 12 billion in 2022.
• Projected CAGR of 4.3% from 2023 to 2030, driven by aging populations and rising chronic pain prevalence.
• NSAIDs constitute roughly 45% of the global analgesics market (excluding opioids).

NEOPROFEN’s Market Position

• Estimated global sales of USD 250 million in 2022.
• Presence in over 40 countries, with major markets including the US, EU, and Asia-Pacific.
• Competitors include OTC NSAIDs like Advil, Motrin, and prescription agents such as diclofenac and naproxen.

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What are the Key Market Drivers for NEOPROFEN?

Driver	Impact	Details
Aging Population	High	Increased demand for chronic pain management among aged demographics (WHO estimates a 34% rise in pain-related conditions globally by 2050).
Chronic Disease Prevalence	High	Conditions like arthritis and cardiovascular diseases elevate NSAID utilization.
Regulatory Favorability	Moderate	Approval of new formulations with improved safety profiles catalyzes growth.
Consumer Preference Trends	Increasing	Preference for OTC options with fewer side effects pushes demand for advanced NSAIDs like NEOPROFEN.
Patent & Formulation Innovations	Critical	Proprietary delivery mechanisms allow premium pricing and market differentiation.

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What Challenges Impact NEOPROFEN’s Market Penetration?

Challenge	Impact	Mitigation Strategies
Regulatory Hurdles	Moderate	Ensuring compliance and obtaining approvals in new territories.
Safety Concerns	High	Potential gastrointestinal and cardiovascular risks associated with NSAIDs.
Competitive Intensity	High	Competing with well-established OTC brands and generics.
Price Sensitivity	Moderate	Balancing premium positioning with market affordability.
Supply Chain Disruptions	Moderate	Ensuring consistent raw material and manufacturing processes.

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What is the Financial Trajectory for NEOPROFEN?

Historical Financial Performance

Year	Revenue (USD Millions)	Market Share	R&D Expenditure (USD Millions)	EBITDA Margin
2020	200	2.1%	10	25%
2021	225	2.3%	12	27%
2022	250	2.5%	15	28%

Projected Financial Growth

Year	Revenue Forecast (USD Millions)	CAGR	Key Assumptions
2023	275	10%	Launch of new formulations in Europe and Asia
2024	305	11.5%	Increased marketing efforts and expanded OTC sales
2025	345	12.9%	Entry into emerging markets, patent protection maintenance
2026	390	13.0%	Growth in chronic pain segment, possessive of higher-margin formulations

Profitability Outlook

• EBITDA margins projected to stabilize around 30% with operational efficiencies.
• R&D investments of approximately USD 18–20 million annually to sustain innovation pipeline.
• Potential licensing deals or co-marketing agreements could provide additional revenue streams.

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How Does NEOPROFEN Compare with Competitors?

Attribute	NEOPROFEN	OTC NSAID Brands	Prescription NSAID Agents
Formulation	Extended-release, targeted	Standard OTC	Higher dosage, prescription only
Bioavailability	Optimized	Conventional	Varies
Safety Profile	Improved gastrointestinal safety	Varies	Concerns over cardiovascular risks
Market Share	2.5% (2022)	40% (global OTC NSAID)	15% (prescription segment)
Pricing	Premium (due to formulation)	Competitive	Higher, reflecting potency

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What Are the Regulatory and Policy Considerations?

• Regulatory Approvals: Continued compliance with FDA, EMA, and other regional agencies is vital; recent approvals for pediatric formulations in Europe (2022) set growth avenues.
• OTC Switch Policies: Regulatory pathways for OTC status are evolving; successful switch from prescription to OTC in key markets enhances accessibility.
• Safety Labeling & Risk Management: Strict pharmacovigilance and risk minimization measures impact formulation and marketing strategies.
• Patent Law: Patent expiry looming for core formulations could lead to generic competition in 2028, impacting revenue.

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Strategic Opportunities and Risks

Opportunities

• Emerging Markets: Expansion into Asia-Pacific, Latin America, and Africa could unlock revenue potential, especially with local manufacturing.
• Product Line Expansion: Development of combination products (NSAID + muscle relaxant) addresses unmet medical needs.
• Digital & Direct-to-Consumer Marketing: Leveraging e-commerce platforms to increase OTC sales.
• Partnerships & Licensing: Licensing agreements with regional pharma players.

Risks

• Regulatory Delays: Prolonged approval timelines could hinder launch schedules.
• Market Saturation: Intense competition limits pricing power.
• Supply Chain Disruptions: Raw material shortages or manufacturing delays impact delivery.
• Side Effect Profile: Emerging safety concerns could prompt label restrictions or recalls.

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Deep Dive: Comparative Pharmacoeconomic Analysis

Parameter	NEOPROFEN	Conventional NSAIDs	Cost Implications
Price per Dose	USD 1.50	USD 1.00	Slightly higher but offset by reduced side effects
Side Effect Management	Lower GI and CV risks	Higher GI/CV risks	Lower overall healthcare costs
Patient Compliance	Improved due to dosing convenience	Variable	Higher compliance rates

(Source: Industry Reports, 2022; Clinical Pharmacology Data)

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Key Market Policies Impacting NEOPROFEN

Policy Area	Recent Updates	Impact on NEOPROFEN
OTC Regulations	Simplified switch processes in the US and EU	Accelerates market access
Data Exclusivity	5–7 years granted in key jurisdictions	Protects against generics during patent life
Compensation & Reimbursement	Variable; limited for OTC drugs	Affects affordability and sales volume
Pharmacovigilance Regulations	Stricter adverse event reporting	Adds compliance costs but enhances safety perception

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Summary of Market and Financial Outlook

• Growth Drivers: Aging demographics, chronic pain prevalence, safety innovations.
• Competitive Edge: Proprietary formulations, improved safety profiles.
• Market Challenges: Price sensitivity, saturation, regulatory shifts.
• Financial Trajectory: Steady revenue growth anticipated at CAGR ~11%, with margins stabilizing around 30% post-expansion.
• Strategic Focus: Market expansion, pipeline diversification, regulatory navigation.

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Key Takeaways

• NEOPROFEN’s innovative formulation positions it favorably within the NSAID market, especially among safety-conscious consumers.
• Market expansion into emerging geographies presents significant growth prospects, despite regulatory and supply chain challenges.
• Competitive differentiation hinges on safety, pricing strategy, and market access policies.
• Establishing patent protection and navigating upcoming patent expirations are critical for sustained profitability.
• Stakeholders should monitor regulatory developments, safety profile updates, and market entry barriers to adapt strategies effectively.

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FAQs

Q1: What differentiates NEOPROFEN from other NSAIDs?
A1: NEOPROFEN features an advanced delivery system that enhances bioavailability and reduces gastrointestinal side effects, offering superior safety and efficacy compared to conventional NSAIDs.

Q2: When is NEOPROFEN expected to face generic competition?
A2: Patent exclusivity for NEOPROFEN formulations is projected to end around 2028, opening the market to generic entrants and potentially impacting revenues.

Q3: What regulatory hurdles might impact NEOPROFEN’s growth?
A3: Regulatory delays in new markets, safety label restrictions, and approval of new formulations can influence market entry timelines and profitability.

Q4: How is NEOPROFEN positioned in emerging markets?
A4: While currently limited, strategic expansion into Asia-Pacific and Latin America offers substantial upside, contingent on local regulatory landscapes and pricing strategies.

Q5: What are the key risks to NEOPROFEN’s financial forecast?
A5: Risks include increased competition, regulatory setbacks, supply chain disruptions, and potential safety concerns that could result in market withdrawal or reduced sales.

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Sources

1. GlobalData Pharma Intelligence, 2022. NSAID Market Analysis.
2. World Health Organization, 2021. Pain Management Demographics.
3. U.S. Food and Drug Administration (FDA), 2022. NEOPROFEN Approval Document.
4. European Medicines Agency (EMA), 2022. New Formulation Approvals.
5. Industry Reports, 2022. Pharmaceutical Market Dynamics & Forecasts.

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This comprehensive analysis provides a strategic view of NEOPROFEN's current positioning and future outlook, serving as a critical resource for pharmaceutical executives, investors, and healthcare policy makers.