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:	278
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2
State University of New York - Downstate Medical Center	Phase 2
Food and Drug Administration (FDA)	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
Canada	2377453
European Patent Office	1249234	Méthode de prévention de la rétinopathie chez les nouveaux-nés prématurés (Method of preventing retinopathy of prematurity in a neonate)
Mexico	PA02003033	METODO PARA PREVENIR RETINOPATIA PREMATURA EN UN NEONATO. (METHOD OF PREVENTING RETINOPATHY OF PREMATURITY IN A NEONATE.)
Japan	2002326929	METHOD FOR PREVENTING RETINOPATHY OF PREMATURITY IN HEWBORN INFANT
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)
Austria	293444
Germany	60110185

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

NEOPROFEN Market Analysis and Financial Projection

Last updated: April 24, 2026

NEOPROFEN: Market Dynamics and Financial Trajectory

NEOPROFEN is a brand name for the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen (commonly formulated as topical gel in many markets). Market dynamics for ketoprofen products are shaped by (1) class-level NSAID demand (pain and inflammation), (2) switchability across NSAIDs (substitution is frequent), (3) channel concentration (pharmacies plus outpatient clinics), and (4) competitive intensity from multiple generics with steep price competition. The financial trajectory typically follows a genericization curve: revenue peak pre-generic, then erosion in mature markets, with upside mainly from new geographies, packaging reformats, and differentiated product forms (for example, topical delivery).

Below is the market-structure view and the financial pattern investors and R&D teams typically use for NEOPROFEN-style ketoprofen brands, anchored to how the ketoprofen NSAID class trades after patent expiry.

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What drives demand for NEOPROFEN (ketoprofen) across channels?

1) Use case maps to repeatable, clinic- and OTC-style consumption

Ketoprofen-based products track with persistent prevalence of:

• Musculoskeletal pain
• Sports and minor injury pain
• Inflammatory conditions treated in outpatient settings
• Chronic pain regimens where NSAIDs are used intermittently

Topical NSAIDs shift volume toward:

• Pharmacy retail replenishment
• Clinic recommendations for localized pain
• Reduced systemic-risk comparisons versus oral NSAIDs, which can influence prescriber preference in specific patient segments (local tolerability and risk profile are key).

2) Competitive substitution is structurally high

NEOPROFEN competes inside the NSAID class and often inside ketoprofen generics as well. Substitution tends to occur when:

• Multiple labeled strengths and formulations exist
• Generic equivalents are widely available
• Physicians treat by class rather than by single brand
• Payers and formularies standardize NSAID coverage

This structure compresses pricing after maturity because switching costs are low.

3) Differentiation comes from formulation and local market compliance

For topical ketoprofen brands, price and share outcomes often hinge on:

• Gel penetration and dosing convenience (posology clarity and tube size matter)
• Label claims (indication wording and approved patient populations)
• Bioavailability and tolerability perceptions versus competing NSAIDs
• Package formats that align with physician prescribing habits

In practice, “brand” value persists when the product is perceived as reliably effective and easy to use, not when molecule-level novelty exists.

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How do pricing and margins typically evolve as NEOPROFEN matures?

1) Post-patent pricing trajectory: rapid erosion, then stabilization

For brands with ketoprofen active substance, the common pathway is:

• Pre-generic phase: brand pricing holds, promotion supports share.
• Generic entry: price compression accelerates and share migrates to lowest-priced equivalents, especially where wholesalers and retailers push price.
• Maturity: unit price stabilizes but at a lower baseline; margin becomes dependent on mix (pack size), promotional intensity, and trade terms.

2) Margin mix: channel and contract terms matter more than molecule

Unlike specialty drugs with payer constraints tied to evidence, mature OTC or semi-OTC-style NSAID markets usually monetize through:

• Wholesaler and distributor rebates
• Pharmacy margins
• Trade promotions and end-cap placements
• Volume discounts on higher tube sizes

Cost control is often dominated by:

• Packaging formats and SKUs
• Distribution efficiency
• Trade spend intensity

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What does the financial trajectory look like in real-world terms?

Because NEOPROFEN is a ketoprofen brand, its financial trajectory usually follows ketoprofen NSAID sector mechanics, not blockbuster-style launch economics. The typical value drivers and turning points are:

1) Revenue curve: peak then plateau with incremental growth levers

A realistic curve for a mature ketoprofen brand is:

• Peak revenue around the end of brand exclusivity
• Downtrend after genericization due to pricing pressure and substitution
• Plateau with continued modest growth only if the company:
  • expands into underpenetrated geographies
  • introduces new formulations (where allowed)
  • improves compliance through packaging or dosing convenience
  • runs targeted channel promotions

2) Cash flow pattern: declining gross margin but stable working capital

As unit price declines:

• Gross margin compresses, but volumes can remain steady if share loss is limited.
• Operating leverage improves only if marketing and overhead scale down proportionally.
• Working capital can improve if distribution terms are tightened and receivable cycles shorten.

3) Investment profile: low-to-moderate pipeline option value

For investors, ketoprofen topical brands generally score:

• Low probability of large incremental revenue per brand SKU
• Higher value from portfolio breadth (more SKUs or more geographies)
• Risk concentrated in regulatory lifecycle events and competitive pricing

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Competitive landscape: what pressures NEOPROFEN’s share and price?

1) Generic ketoprofen and therapeutic alternatives

Ketoprofen competes against:

• Other topical NSAIDs (same anatomical pain segments)
• Oral NSAIDs and combination analgesic products
• Other local analgesics and anti-inflammatory actives depending on market rules

This broad therapeutic overlap increases the speed at which buyers can switch.

2) Retail and pharmacy power

Pharmacy chains and wholesalers often negotiate:

• Price tiers by SKU
• Promotional calendars and stocking requirements
• Private label or “value” assortment substitution

That dynamic limits brand power once multiple equivalents are available.

3) Marketing intensity becomes the battleground

As molecule IP fades, marketing spend shifts toward:

• Indication reinforcement (localized pain)
• Patient-friendly instructions
• Safety messaging (where relevant)
• Seasonal boosts around injury and activity periods

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Regulatory and product lifecycle effects on revenue timing

Ketoprofen topical products typically face revenue-shaping events like:

• Variation approvals (formulation changes)
• Manufacturing site changes
• Label updates and safety communications
• Periodic re-registration cycles in specific jurisdictions

These do not create sudden revenue steps like a new molecular entity, but they can cause short-term supply constraints or relabeling-driven channel delays that temporarily affect revenue.

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Financial trajectory scenarios: how outcomes diverge after generic entry

Scenario A: “Share-retention” plays out

Revenue declines slower than category due to:

• Strong pharmacy relationships
• Better perceived effectiveness or tolerability
• Dosing convenience and packaging
• Local brand recognition

Financial pattern: moderate revenue erosion, faster margin erosion, relatively stable cash generation.

Scenario B: “Low-cost substitution” dominates

Revenue declines faster due to:

• Aggressive generic pricing
• Weak trade terms
• Lower promotional intensity
• Reduced shelf presence

Financial pattern: faster revenue contraction, sharper margin loss, higher volatility from promotional pricing.

Scenario C: “Formulation differentiation” extends the runway

Revenue is maintained longer through:

• New pack formats (dose size, tube volume)
• Enhanced delivery vehicle changes (where regulatory allows)
• Indication wording expansion in specific markets

Financial pattern: slower unit price decline, improved volume retention, margin better supported by differentiation.

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Key metrics to track for NEOPROFEN’s financial trajectory

Even without proprietary sales data, investors can monitor the economic signals that control pricing and revenue in this category:

Metric	What it indicates	Why it matters for NEOPROFEN
Competitive number of equivalents	Degree of substitution pressure	More equivalents usually means lower price and faster share loss
Wholesale-to-retail discount levels	Trade competitiveness	Determines if NEOPROFEN stays shelf-relevant
Average selling price (ASP) trend	Pricing power vs generics	ASP compression tracks generic maturity
Rx vs OTC share	Channel economics	OTC and pharmacy retail drive different margin structures
SKU and pack size mix	Revenue stability through “unit economics”	Larger packs can stabilize revenue after ASP falls
Promotional spend intensity	Short-term volume support	Can slow share loss but compress margin

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Key Takeaways

• NEOPROFEN is a ketoprofen NSAID brand, and its market dynamics follow mature NSAID mechanics: high substitution, price compression, and volume-dependent revenue.
• The typical financial trajectory is post-exclusivity decline, then stabilization at lower pricing, with incremental gains driven mainly by geographic expansion, formulation/pack differentiation, and channel execution.
• Long-term profitability depends more on trade terms, mix, and shelf presence than on molecule-level novelty.
• The category’s competitive pressure makes revenue growth possible but incremental; large upside usually requires differentiation that changes channel economics or reduces effective substitution.

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FAQs

1) Is NEOPROFEN a standalone unique molecule?
No. NEOPROFEN is tied to the ketoprofen NSAID class, where competitive substitution by equivalents and other topical/oral NSAIDs is structurally common.

2) What most affects NEOPROFEN pricing in mature markets?
Generic ketoprofen availability and competing NSAID alternatives drive pricing pressure, with shelf and trade negotiations determining the effective price.

3) Does NEOPROFEN revenue behave like a blockbuster launch?
No. The revenue pattern in this class usually looks like exclusivity peak, then erosion with partial stabilization, driven by channel and competitive pricing rather than sustained high pricing power.

4) Where can NEOPROFEN still grow after genericization?
Growth is typically incremental through underpenetrated geographies, differentiated topical formulation or pack formats, and sustained channel execution.

5) What are the best leading indicators of NEOPROFEN financial trajectory?
ASP trend, equivalent count, wholesale-to-retail discounting, promotional intensity, and SKU/pack mix.

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References

[1] European Medicines Agency (EMA). NSAIDs: information on use and safety communications (class context). https://www.ema.europa.eu/
[2] World Health Organization (WHO). Analgesics and anti-inflammatory medicines (general public health context for NSAID use). https://www.who.int/
[3] FDA (U.S. FDA). NSAID class safety labeling and consumer drug information (class context). https://www.fda.gov/drugs