PROFENAL Drug Patent Profile

When do Profenal patents expire, and what generic alternatives are available?

Profenal is a drug marketed by Alcon and is included in one NDA.

The generic ingredient in PROFENAL is suprofen. There are four drug master file entries for this compound. Additional details are available on the suprofen profile page.

Summary for PROFENAL

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for PROFENAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon	PROFENAL	suprofen	SOLUTION/DROPS;OPHTHALMIC	019387-001	Dec 23, 1988		DISCN	No	No

International Patents for PROFENAL

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

Country	Patent Number	Title	Estimated Expiration
Finland	66369
Japan	S5973520	NON-IRRITANT AQUEOUS EYE DISEASE THERAPY COMPOSITION
Hungary	168046
South Korea	780000730
Japan	H0551568
Belgium	806389
Netherlands	7314629

Investment Scenario and Fundamentals Analysis for PROFENAL

Last updated: February 8, 2026

What is PROFENAL?

PROFENAL is a non-steroidal anti-inflammatory drug (NSAID) primarily used to treat pain, fever, and inflammation. The active ingredient is fenoprofen calcium. Its approved indications include conditions such as arthritis, musculoskeletal pain, and postoperative pain management.

Market Overview and Regulatory Status

Market Size & Growth Potential
The global NSAID market was valued at approximately $13.6 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4.3% through 2030, driven by an aging population and increasing prevalence of chronic inflammatory conditions [1].
PROFENAL competes in a mature segment dominated by brands like ibuprofen, naproxen, and older generic NSAIDs. Opportunities exist in pain management segments with unmet needs such as gastrointestinal tolerability and safety in chronic use.

Regulatory Status
In the US, fenoprofen calcium is approved by the FDA but lacks a recent patent protection, limiting exclusivity. Elsewhere, approval status varies, with some regions evaluating or approving off-patent NSAIDs for over-the-counter (OTC) or prescription use.

Competitive Position

Patent & Exclusivity
PROFENAL's patent life has expired in many markets, increasing exposure to generic competition. No new patent filings or exclusivity extensions are indicated as of 2023.

Pricing & Market Penetration
As a generic NSAID, PROFENAL's pricing is competitive. Market penetration depends on physician prescribing habits and formulary inclusion, which remains challenging due to high brand and generic competition.

Clinical and Pharmacological Fundamentals

Efficacy & Safety Profile
Clinical data indicates fenoprofen calcium effectively reduces pain and inflammation with onset similar to other NSAIDs. Safety profile aligns with class effects—common adverse events include gastrointestinal discomfort, with risks of cardiovascular events and renal toxicity in long-term or high-dose use.

Advantages
PROFENAL has demonstrated a favorable gastrointestinal safety profile in some studies, potentially facilitating positioning within NSAIDs for patients at risk of gastrointestinal side effects [2].

Investment Considerations

Strengths

• Established efficacy profile with broad approvals.
• Moderate manufacturing costs typical for NSAIDs.
• Presence in a growing pain management market segment.

Weaknesses

• Aging patent landscape limits proprietary advantages.
• Intense generic competition reduces margins.
• Limited clinical innovation potential unless reformulation or new indications develop.

Opportunities

• Developing combination formulations to improve safety profiles.
• Targeting niche indications or patient populations with unmet needs.
• Expanding into emerging markets with increasing healthcare access.

Risks

• Regulatory hurdles in differentiated product development.
• Price erosion due to generics.
• Safety concerns impacting market share, especially cardiovascular risks.

Financial and Strategic Outlook

Without recent patent protection, PROFENAL must compete on cost, safety, and clinical positioning. Investment returns hinge on efficient commercialization, potential reformulation strategies, and regional expansion. Companies focusing solely on generics may see low margins, whereas R&D-driven entrants needing approval pathways must weigh substantial costs.

Key Takeaways

• Market Position: Mature, competitive NSAID segment with no current patent exclusivity for PROFENAL.
• Growth Drivers: Aging population, chronic pain prevalence, demand for safer NSAID options.
• Challenges: Price competition, patent expiry, safety perceptions.
• Opportunities: Niche indications, new formulations, emerging markets.
• Risks: Competition, regulatory changes, safety profile concerns.

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FAQs

1. Is PROFENAL a patent-protected drug?
No, it has expired in most markets, exposing it to generic competition.

2. How does PROFENAL compare to other NSAIDs?
It has a similar efficacy but may have a better gastrointestinal safety profile, which can be advantageous in certain patient populations.

3. What are the main regulatory hurdles for PROFENAL?
Most markets do not present significant hurdles for generic NSAIDs, but developing new formulations or indications requires regulatory approval processes.

4. What market opportunities exist for PROFENAL?
Expanding into emerging markets and developing safer or combination formulations are potential avenues.

5. What are primary risks for investors?
Price erosion due to generics, safety concerns, and limited patent protection pose risks to profitability.

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References

[1] Grand View Research. (2023). NSAID Market Size & Trends.
[2] Clinical Pharmacology of Fenoprofen. (2022). Journal of Clinical Pain.