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Last Updated: March 26, 2026

Suprofen - Generic Drug Details


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What are the generic drug sources for suprofen and what is the scope of patent protection?

Suprofen is the generic ingredient in one branded drug marketed by Alcon and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for suprofen.

Summary for suprofen
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 4
Raw Ingredient (Bulk) Api Vendors: 84
Clinical Trials: 1
DailyMed Link:suprofen at DailyMed
Recent Clinical Trials for suprofen

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

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all suprofen clinical trials

Medical Subject Heading (MeSH) Categories for suprofen

US Patents and Regulatory Information for suprofen

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Suprofen Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Suprofen?

Suprofen is a nonsteroidal anti-inflammatory drug (NSAID) primarily used in ophthalmology to treat conjunctivitis and other ocular inflammatory conditions. Its global market is limited by clinical scope, regulatory status, and competition.

Market Size and Segmentation

The ophthalmic NSAID market, which includes drugs like diclofenac, ketorolac, and suprofen, was valued at approximately $400 million in 2021 and is projected to grow at a compounded annual growth rate (CAGR) of 4-6% through 2028. Suprofen’s share within this segment remains small due to limited approval, manufacturing discontinuation in some regions, and competition from other NSAIDs.

Regulatory Status and Regional Availability

Supprofen's approval is restricted to specific markets. For example, it was approved in the United States in the 1980s but later withdrawn from the market due to safety concerns and the availability of alternative drugs. Regulatory actions by the FDA and EMA influence its commercial viability elsewhere, with some markets permitting limited use and others limiting or disallowing its sale.

Competitive Landscape

Suprofen faces competition from other ophthalmic NSAIDs like bromfenac, nepafenac, and ketorolac. These drugs exhibit longer durations of action, better safety profiles, and broader approval. The competitive pressure has led to a decline in Suprofen’s market presence. Pharmaceutical companies focus R&D efforts on newer delivery systems, compounds, and indications, reducing demand for older drugs like Suprofen.

Patent and Patent Expiry

Suprofen's patent life has long expired, decreasing exclusivity and allowing generic manufacturers to produce it. This impacts pricing strategies, leading to lower retail prices and eroding profit margins for any remaining manufacturer.

Supply Chain and Manufacturing Trends

Manufacturing of Suprofen is limited, with production mainly by contract manufacturers. Any disruptions or discontinuations influence availability, further limiting market penetration. As it is an older drug, active ingredient synthesis is well-established, but complexities of modern pharmaceutical manufacturing and regulatory compliance diminish the likelihood of renewed or expanded production.

What Is the Financial Trajectory for Suprofen?

Historical Revenue and Market Performance

Suprofen’s revenue peaked in the late 1980s but declined rapidly following market withdrawals, safety concerns, and competition. Since then, it has maintained minimal sales, mostly from generic producers with negligible contribution to overall revenue.

Current Revenue and Market Penetration

In 2022, estimated global sales were below $10 million, mostly from legacy markets and generic supply chains. The drug’s market penetration remains negligible due to regulatory restrictions and obsolescence in ophthalmic practice.

Profitability and Cost Structure

Profit margins for the remaining Suprofen products are thin because of low prices, generic competition, and minimal marketing costs. Manufacturing costs are stable but subject to scale limitations. Regulatory costs are minimal given its limited market status, but potential liabilities from adverse event reporting could influence costs.

Future Revenue Projections

Remaining sales are projected to decline gradually, approaching negligible levels by 2025. Drug developers and generic manufacturers are unlikely to invest significantly in renewal or new indications due to limited market potential and regulatory uncertainties.

Investment Opportunities and Risks

Investors should consider the decline in existing revenue streams, regulatory hurdles for market re-entry, and competition from newer NSAIDs. Any revival depends on reformulation, new indications, or regulatory approvals, all of which face significant barriers.

Key Takeaways

  • Suprofen operates mainly in the niche ophthalmic NSAID market, which is expected to grow modestly.
  • Its regulatory withdrawal or limited approval restricts market presence and growth.
  • The drug faces intense competition from newer NSAIDs with better safety profiles and longer durations of action.
  • Market sales are minimal, primarily from legacy and generic sources; growth prospects are negligible.
  • Future revenue trajectories show continued decline, with significant barriers to market re-entry.

FAQs

1. Why was Suprofen withdrawn from some markets?
Safety concerns and the availability of alternative drugs led regulators like the FDA to withdraw Suprofen in the late 1980s and early 1990s.

2. Are there any ongoing clinical trials involving Suprofen?
No significant clinical trials are active, given its limited approved uses and competition from newer NSAIDs.

3. Can Suprofen be reformulated for other indications?
Possible but unlikely. The drug’s safety profile and regulatory history make repurposing difficult without substantial clinical evidence and approval.

4. How does Suprofen compare to other ophthalmic NSAIDs?
It has a shorter duration of action and higher safety concerns relative to drugs like bromfenac or nepafenac, which are preferred due to efficacy and safety.

5. Will Suprofen regain market approval?
Unlikely in the near term due to outdated formulation, safety concerns, and competition. Market re-approval would require extensive clinical trials and regulatory clearance.


Sources
[1] MarketData Forecast, 2022. Ophthalmic NSAID Market Report.
[2] U.S. Food and Drug Administration (FDA) records.
[3] Pharmaceutical pricing and patent expiry database, 2022.

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