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Last Updated: January 29, 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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SUPROFEN

Last updated: July 29, 2025


Introduction

Suprofen, a non-steroidal anti-inflammatory drug (NSAID), has historically played an important role in managing pain and inflammation associated with musculoskeletal disorders and postoperative conditions. Its journey through clinical development, regulatory approval, and commercial deployment illustrates broader themes in pharmaceutical market dynamics, including competitive positioning, regulatory landscape, patent status, and shifting treatment paradigms. This analysis dissects the key drivers shaping the market trajectory of Suprofen, alongside its current financial outlook.


Historical Context and Pharmacological Profile

Suprofen was originally synthesized in the 1970s and gained approval as an ophthalmic solution and systemic NSAID for pain relief. Its pharmacological action involves cyclooxygenase (COX) inhibition, reducing prostaglandin synthesis. Noteworthy was its efficacy in ocular inflammatory conditions and postoperative analgesia, especially in ophthalmology. However, systemic formulations faced safety concerns, particularly regarding gastrointestinal (GI) adverse effects, which prompted the development of newer NSAIDs with improved safety profiles.


Market Dynamics

1. Regulatory Environment and Patent Landscape

Suprofen’s initial patent protections have long expired, limiting its exclusivity and opening pathways for generic competition. As a result, the commercial revenue for branded Suprofen products has declined sharply over the past decade. Regulatory agencies like the FDA have also limited its indications due to safety concerns, especially risks of GI bleeding and renal impairment, common to first-generation NSAIDs.

The expiration of patents and increased safety scrutiny have shifted focus toward newer NSAIDs and selective COX-2 inhibitors, notably celecoxib and etoricoxib, which claimed market share by offering better safety profiles in specific patient populations. Nonetheless, Suprofen maintains niche usage, particularly in ophthalmology, where patented formulations or delivery systems might offer unique opportunities.

2. Competitive Landscape

Suprofen's primary competitors include other NSAIDs such as ketoprofen, diclofenac, and ibuprofen, alongside COX-2 inhibitors. In ophthalmology, drugs like diclofenac and ketorolac serve as alternatives, with newer agents incorporating advanced delivery methods (e.g., sustained-release implants, eye drops with enhanced bioavailability).

The shift to topical and ophthalmic formulations is advantageous for Suprofen’s branded version, mitigating systemic adverse effects and potentially allowing sustained or targeted therapies. However, the prevalence of generics and the dominance of established NSAIDs have limited growth prospects.

3. Market Segmentation

  • Ophthalmic Use: Suprofen remains relevant due to its efficacy in treating postoperative ocular inflammation and pain. Ophthalmic formulations, especially as eye drops, benefit from specialized delivery mechanisms, which could rejuvenate its market share if supported by clinical data and regulatory approvals.

  • Systemic Use: Reduced due to safety concerns and availability of superior alternatives.

  • Niche and Off-label Uses: Limited scope exists here owing to safety profiles and competition from other NSAIDs and analgesics like acetaminophen.

4. Prescriber and Patient Trends

Increasing awareness of NSAID-associated risks influences prescribing behavior. Physicians prefer drugs with proven safety profiles, support for long-term use, or targeted delivery systems. Patients increasingly demand formulations with fewer adverse effects, pushing innovation toward topical or ocular applications for Suprofen.


Financial Trajectory

1. Revenue Trends

Suprofen’s market revenues have historically declined due to patent expiration, generic proliferation, and safety concerns. The ophthalmic segment offers some revenue potential through specialized formulations, but overall sales remain modest compared to newer or better-established drugs.

2. R&D and Innovation Investments

Pharmaceutical companies developing Suprofen derivatives or reformulations are likely investing in innovative delivery systems, such as sustained-release ocular inserts or combination therapies, to extend lifecycle and market relevance. These investments are pivotal for establishing differentiation amidst generic competition and safety considerations.

3. Price Point and Market Penetration

Pricing strategies for Ophthalmic formulations tend to be higher due to specialized indications and delivery mechanisms; however, reimbursement policies and insurance coverage influence market penetration. Off-patent formulations are often priced competitively, constraining profit margins for innovators.

4. Market Potential and Forecasts

Given the current landscape, Suprofen’s market position appears stable but limited. The primary growth drivers include:

  • Niche ophthalmic indications with an unmet need for targeted inflammation control.
  • Innovative delivery systems that enhance efficacy and safety.
  • Potential approval expansions for new indications or patient populations.

Most industry forecasts predict limited growth, emphasizing that Suprofen will likely serve niche markets rather than achieve broad therapeutic dominance.


Key Factors Shaping Future Financial Outcomes

  • Regulatory approvals and safety profiles will dictate adoption, especially in specialized ophthalmic applications.
  • Advances in drug delivery—such as sustained-release eye drops—could catalyze renewed interest and revenue growth.
  • Market acceptance and reimbursement policies are critical, with payers favoring safer, cost-effective alternatives.
  • Competitive innovations and patent strategies will influence market share and profitability margins.
  • Global market conditions and emerging healthcare access policies in developing markets may present additional growth avenues.

Conclusion

Suprofen’s market dynamics are characterized by a transition from broad systemic applications towards niche ophthalmic uses, driven by safety considerations and evolving technology. Its financial trajectory points to modest, possibly stabilizing revenues, contingent on innovation and regulatory pathways. While its generic counterparts dominate the systemic NSAID space, Suprofen's specialized formulations and potential for reformulation underpin its sustained, albeit limited, market presence.


Key Takeaways

  • Suprofen’s patent expiry and safety concerns have diminished its systemic market share, positioning it as a niche ophthalmic agent.
  • The drug’s future financial success hinges on innovation in delivery methods, particularly sustained-release ocular formulations.
  • Competitive pressures from newer NSAIDs and COX-2 inhibitors limit its broader adoption.
  • Market growth is primarily driven by specialized indications, with overall revenue prospects remaining modest.
  • Strategic investments in formulation technology and regulatory positioning are essential for extending Suprofen’s commercial lifespan.

FAQs

1. What are the primary therapeutic uses of Suprofen today?
Suprofen is mainly used in ophthalmology for controlling postoperative ocular inflammation and pain, given its efficacy when formulated as eye drops. Its systemic use has declined due to safety concerns and competition.

2. How does Suprofen compare safety-wise to newer NSAIDs?
Suprofen, being a first-generation NSAID, carries similar risks of GI bleeding and renal impairment compared to other non-selective NSAIDs. Newer agents with COX-2 selectivity tend to have improved safety profiles but still pose cardiovascular risks.

3. Is there potential for Suprofen in developing markets?
Potential exists in markets with limited access to newer drugs, provided regulatory pathways are favorable. However, safety issues and competition from generic NSAIDs may limit its market share.

4. What innovations could boost Suprofen’s market presence?
Development of advanced delivery systems, such as sustained-release ocular inserts or eye drops with enhanced bioavailability, could improve efficacy and safety, expanding its clinical utility.

5. How does patent status affect Suprofen's market outlook?
Expired patents have led to generic competition, suppressing branded sales. Without new patent protections or formulations, revenue potential remains constrained.


References

[1] Drugs.com. Suprofen. Available at: https://www.drugs.com.
[2] U.S. Food and Drug Administration. Drug Approvals and Safety Communications.
[3] Market Research Future. NSAID Market Analysis and Forecast.
[4] GlobalData. Ophthalmic Drugs Market.
[5] PubMed. Clinical studies on Suprofen formulations and safety profiles.

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