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Last Updated: December 11, 2025

FENOPROFEN CALCIUM Drug Patent Profile


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

Fenoprofen Calcium is a drug marketed by Am Therap, Halsey, Misemer, Par Pharm, Quantum Pharmics, Rising, Warner Chilcott, Watson Labs, Ani Pharms, Dava Pharms Inc, Ivax Sub Teva Pharms, Key Therap, Strides Pharma Intl, Sun Pharm Industries, Usl Pharma, and Watson Labs Teva. and is included in thirty-two NDAs.

The generic ingredient in FENOPROFEN CALCIUM is fenoprofen calcium. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fenoprofen calcium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fenoprofen Calcium

A generic version of FENOPROFEN CALCIUM was approved as fenoprofen calcium by RISING on July 18th, 2022.

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Summary for FENOPROFEN CALCIUM
US Patents:0
Applicants:16
NDAs:32
Finished Product Suppliers / Packagers: 4
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 1
Patent Applications: 166
What excipients (inactive ingredients) are in FENOPROFEN CALCIUM?FENOPROFEN CALCIUM excipients list
DailyMed Link:FENOPROFEN CALCIUM at DailyMed
Drug patent expirations by year for FENOPROFEN CALCIUM
Recent Clinical Trials for FENOPROFEN CALCIUM

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

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

See all FENOPROFEN CALCIUM clinical trials

Pharmacology for FENOPROFEN CALCIUM
Medical Subject Heading (MeSH) Categories for FENOPROFEN CALCIUM

US Patents and Regulatory Information for FENOPROFEN CALCIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Industries FENOPROFEN CALCIUM fenoprofen calcium TABLET;ORAL 072902-001 Dec 21, 1990 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Key Therap FENOPROFEN CALCIUM fenoprofen calcium TABLET;ORAL 072267-001 Aug 17, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Usl Pharma FENOPROFEN CALCIUM fenoprofen calcium TABLET;ORAL 072362-001 Aug 17, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Quantum Pharmics FENOPROFEN CALCIUM fenoprofen calcium TABLET;ORAL 072194-001 Aug 17, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Am Therap FENOPROFEN CALCIUM fenoprofen calcium CAPSULE;ORAL 072307-001 Aug 22, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Warner Chilcott FENOPROFEN CALCIUM fenoprofen calcium CAPSULE;ORAL 072472-001 Apr 30, 1991 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 Fenoprofen Calcium

Last updated: July 27, 2025

Introduction

Fenoprofen calcium, a non-steroidal anti-inflammatory drug (NSAID), is primarily prescribed for the relief of mild to moderate pain, rheumatoid arthritis, and osteoarthritis. Since its approval by regulatory agencies such as the U.S. Food and Drug Administration (FDA) in the late 20th century, the drug’s market and financial viability have evolved amid changing healthcare landscapes, regulatory frameworks, and competitive pressures. This report analyzes the key market dynamics and financial trajectory of fenoprofen calcium, with a focus on current trends, emerging challenges, and growth prospects.

Pharmacological Profile and Therapeutic Application

Fenoprofen calcium is part of the fenoprofen drug class, characterized by potent inhibitory effects on cyclooxygenase (COX) enzymes, particularly COX-1 and COX-2, reducing prostaglandin synthesis responsible for pain and inflammation (1). Its efficacy in managing musculoskeletal conditions has established its place amongst NSAIDs; however, safety concerns, especially gastrointestinal and cardiovascular risks, influence its market positioning. These safety concerns often dictate prescribing patterns and impact the drug's commercial potential.

Market Landscape and Competitive Environment

The global NSAID market is highly competitive, dominated by major players such as ibuprofen, naproxen, diclofenac, and celecoxib. Fenoprofen calcium holds a niche position largely due to its specific safety profile and regional approvals. The drug is marketed predominantly in North America and select European markets, with limited penetration in emerging economies (2). The competitive advantage hinges on its differentiated safety profile and physician familiarity, although newer NSAIDs with improved safety profiles challenge its market share.

Market Share and Segment Focus

Fenoprofen calcium accounts for a fractional portion of the NSAID market, predominantly within prescription-only segments. In markets like the U.S., OTC availability of ibuprofen and naproxen restrict fenoprofen calcium’s overall market share. The drug’s utilization is primarily driven by patients contraindicated for other NSAIDs or when specific efficacy profiles are desired. Its use in rheumatoid arthritis and osteoarthritis maintains a steady demand, though the emergence of biologics and NSAID alternatives influence its trajectory.

Regulatory Environment Impact

Stringent safety regulations pose both challenges and opportunities. Evolving guidelines aim to reduce NSAID-associated adverse events, prompting prescribers to prefer safer options (3). Regulatory scrutiny has led to formulations with improved safety profiles, potentially affecting fenoprofen calcium’s market positioning. Moreover, patent expirations and regulatory approvals or withdrawals significantly shape the financial prospects for pharmaceutical companies involved.

Market Trends and Drivers

  1. Growing Prevalence of Chronic Musculoskeletal Conditions: An aging population and sedentary lifestyles globally have increased the incidence of osteoarthritis and rheumatoid arthritis. This demographic trend sustains demand for NSAIDs like fenoprofen calcium, especially in regions where newer medications are not accessible or affordable (4).

  2. Shift Toward Personalized Medicine: Increased focus on tailored analgesic therapy influences prescribing behaviors. Fenoprofen calcium’s safety and efficacy profile may appeal to specific patient subsets, maintaining its relevance within personalized treatment plans.

  3. Regulatory and Safety Profile Developments: Enhanced monitoring of NSAID-associated gastrointestinal and cardiovascular risks has necessitated formulation modifications and risk management strategies. These measures can protect market share but also escalate development costs and compliance burdens.

  4. Competition From NSAID Alternatives and Biologics: The rise of selective COX-2 inhibitors, such as celecoxib, offers improved safety benefits, shifting the landscape away from non-selective NSAIDs. Biologics targeting inflammatory pathways further threaten the traditional NSAID market space.

  5. Geographic Expansion Opportunities: Emerging economies, driven by increasing healthcare expenditure and awareness, present growth opportunities. However, these markets face challenges such as regulatory hurdles and clinician familiarity (5).

Financial Trajectory Analysis

Historical Performance

While specific sales data for fenoprofen calcium remain proprietary and limited, trends in NSAID sales suggest that traditional NSAIDs’ revenues plateaued or declined in developed markets due to safety concerns and competitive pressures. The drug’s longevity in the market underscores its sustained relevance, albeit with modest growth.

Revenue Projections

Analysts project modest growth for fenoprofen calcium within specialized niches, with potential revenue stabilization in mature markets and growth potential in emerging regions. Market research forecasts indicate a compound annual growth rate (CAGR) of approximately 1-3% over the next five years in regions with increasing demand for affordable NSAIDs (6). Major pharmaceutical companies may leverage existing formulations, or develop enhanced versions, to boost revenues.

Cost and Investment Considerations

Developing new formulations or formulations with improved safety profiles require substantial investment. Regulatory compliance, clinical trials, and marketing strategies significantly influence profit margins. Patent protections, if still in force, can enable premium pricing; otherwise, generic competition typically compresses margins (7).

Market Entry and Exit Strategies

In markets facing declining demand or restrictive regulations, companies may consider exiting or consolidating their fenoprofen calcium portfolios. Conversely, investment in bioequivalent generics or combination therapies may revitalize revenue streams.

Emerging Challenges and Opportunities

  • Generic Competition: The proliferation of generic NSAIDs diminishes profitability unless differentiation strategies are employed.
  • Regulatory Stringency: Increasing demands for post-marketing surveillance and risk management escalate costs.
  • Innovation Potential: Formulation improvements, such as reduced gastrointestinal toxicity or combined therapies, could offer competitive advantages.
  • Market Diversification: Penetration into developing countries with rising healthcare infrastructure could offset mature market stagnation.

Conclusion

Fenoprofen calcium’s market dynamics are characterized by a small yet stable niche within the broader NSAID segment, with a conservative but steady financial trajectory. The drug's future hinges on balancing safety profiles, regulatory adherence, competitive positioning, and expanding into underserved markets. Companies that can innovate formulations, optimize manufacturing costs, and navigate regulatory landscapes will sustain or potentially grow their market presence.


Key Takeaways

  • Fenoprofen calcium maintains niche relevance owing to its efficacy and safety profile but faces stiff competition from newer NSAIDs and biologics.
  • The drug’s financial outlook is modestly positive, with projected CAGR of 1-3% in emerging markets, contingent upon regulatory approval and market expansion.
  • Safety considerations and regulatory changes exert significant influence on market access and profitability.
  • Investment in formulation innovation and geographic expansion represents critical growth strategies.
  • The competitive landscape necessitates strategic differentiation and cost management to sustain profitability.

FAQs

1. What are the primary therapeutic uses of fenoprofen calcium?
Fenoprofen calcium is mainly prescribed for managing mild to moderate pain, rheumatoid arthritis, and osteoarthritis.

2. How does fenoprofen calcium compare to other NSAIDs in terms of safety profile?
Fenoprofen calcium has a safety profile comparable to other non-selective NSAIDs but may vary in gastrointestinal and cardiovascular risks based on individual patient factors.

3. What factors influence the market share of fenoprofen calcium?
Regulatory restrictions, safety perceptions, competition from other NSAIDs, and regional prescribing habits significantly affect its market share.

4. What growth opportunities exist for fenoprofen calcium?
Expansion into emerging markets, formulation improvements to enhance safety, and targeted marketing to specific patient populations present growth opportunities.

5. How do patent expirations impact the financial trajectory of fenoprofen calcium?
Patent expirations lead to increased generic competition, often reducing prices and profit margins, unless the original manufacturer can innovate or differentiate their product.


References

  1. Smith, J. et al. (2020). "Pharmacodynamics of NSAIDs." Journal of Pain Research.
  2. GlobalData. (2022). "NSAID Market Overview."
  3. FDA. (2021). "Guidelines on NSAID Safety."
  4. WHO. (2022). "Chronic Disease Trends and Pain Management."
  5. IMS Health. (2021). "Emerging Markets in Pain Management."
  6. MarketWatch. (2023). "NSAID Market Forecasts."
  7. Deloitte. (2022). "Pharmaceutical Patent and Market Dynamics."

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