Cyclooxygenase Inhibitor Drug Class List

Drugs in Drug Class: Cyclooxygenase Inhibitor

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	218359-001	Mar 26, 2024		OTC	No	No
Bionpharma	ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	216999-001	Aug 1, 2023		OTC	No	No
Dr Reddys	ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	218247-001	Aug 23, 2024		OTC	No	No
Glenmark Pharms Ltd	ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	218311-001	Apr 26, 2024		OTC	No	No
Granules	ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	216592-001	Jul 13, 2023		OTC	No	No
L Perrigo Co	ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	214836-001	Feb 28, 2023		OTC	No	No

Cyclooxygenase Inhibitor Market Analysis and Financial Projection

The global cyclooxygenase (COX) inhibitor market is undergoing significant transformation, driven by evolving therapeutic demands, patent expirations, and innovation in drug development. Here's an in-depth analysis:

Market Dynamics

1. Growth Projections and Drivers

   • The COX-2 inhibitor market is projected to expand at a 12.5% CAGR, rising from $109.91 billion in 2024 to $355.39 billion by 2034, driven by increasing incidences of arthritis and chronic inflammatory diseases[1][3].
   • North America dominates with 15.2% CAGR through 2034, while emerging markets in Asia-Pacific and Latin America show growth potential due to aging populations and healthcare investments[1][5].
   • Key demand drivers include:
     • Rising global arthritis burden (54 million U.S. adults diagnosed)[5].
     • Post-surgical and cancer-related pain management applications[3].
     • Advancements in drug delivery systems and personalized medicine[3][5].

2. Challenges

   • Safety concerns: Cardiovascular risks linked to long-term COX-2 inhibitor use continue to limit prescribing practices[5][10].
   • Generic competition: Patent expirations (e.g., Celecoxib) have lowered prices, reducing branded drug revenues[5].
   • Regulatory scrutiny: Stricter safety evaluations by the FDA and EMA impact market dynamics[12].

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Patent Landscape

1. Key Legal and Innovation Milestones

   • University of Rochester's invalidated patent: A 2000 lawsuit against Pfizer/Pharmacia highlighted risks of overly broad patents tied to basic research[2][9].
   • Procter & Gamble's 196-patent donation: Transferred COX-2 inhibitor IP to Vanderbilt University, enabling new drug discovery initiatives[7].
   • Next-gen innovations:
     • Structural modifications: Hengrui Pharma’s CN118440065A (2024) improved inhibition via tetrazole group replacements[8].
     • Natural extracts: Patents like WO2002047706A2 explore plant-based COX-2 inhibitors[14].

2. Competitive R&D Strategies

   • Top players: Pfizer, Novartis, Bayer, and Teva dominate through reformulation and combination therapies[3][11].
   • Emerging niches:
     • Biodegradable delivery systems and AI-driven drug design[3][12].
     • Precision medicine targeting biomarkers for inflammatory diseases[5].

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Regional and Therapeutic Opportunities

Region	Key Trends	Market Size (2034)
North America	Aging population and arthritis prevalence drive innovation	$115B+[1][5]
Asia-Pacific	Generic expansion and healthcare infrastructure growth	$96.5B (Cox-1)[6]
Europe	Focus on eco-friendly synthesis and automated manufacturing	$60.9B (hospitals)[6]

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Future Outlook

• R&D focus areas: Cardiovascular risk reduction, tumor growth inhibition, and Alzheimer’s applications[7][12].
• Patent trends: Over 47 active patents on novel structures like VX-548 analogs show intense competition[8][11].
• Market shifts: Biosimilars and biologic-engineered inhibitors expected to capture 30% of the market by 2030[4][12].

Highlight: "COX-2 inhibitors may reduce tumor growth by targeting overexpressed enzymes in cancers," notes Verified Market Reports[5].

This landscape underscores a balance between therapeutic demand, innovation-driven growth, and persistent challenges in safety and IP management.

References

1. https://www.factmr.com/report/3221/cox-2-inhibitors-market
2. https://www.science.org/content/article/patent-headache-rochester-university
3. https://www.openpr.com/news/3924759/cox2-inhibitor-industry-to-expand-at-12-5-cagr-surpassing
4. https://patentpc.com/blog/exploring-patentable-elements-anti-inflammatory-drugs/
5. https://www.verifiedmarketreports.com/product/cox-2-inhibitors-market/
6. https://www.gminsights.com/industry-analysis/cyclooxygenase-1-inhibitor-market
7. https://news.vumc.org/reporter-archive/procter-gamble-patents-to-spark-new-drug-discovery/
8. https://synapse.patsnap.com/blog/breakthrough-pain-relief-innovation-patent-exploration-of-next-generation-nav18-inhibitors
9. https://www.bioworld.com/articles/549182-patent-issued-to-university-of-rochester-setting-off-heated-debate-over-rights-to-cox-2-inhibitors
10. https://www.databridgemarketresearch.com/reports/global-cyclooxygenase-2-inhibitor-market
11. https://synapse.patsnap.com/blog/analysis-on-the-research-progress-of-cox-inhibitor
12. https://www.globenewswire.com/news-release/2024/11/28/2988617/28124/en/COX-2-Selective-NSAIDs-Market-Research-Report-2025-2030-Cumulative-Industry-Revenues-to-Exceed-11-3-Billion-by-2030.html
13. https://synapse.patsnap.com/blog/exploring-diflunisals-revolutionary-randd-successes
14. https://patents.google.com/patent/WO2002047706A2/en