PIROXICAM - Generic Drug Details

What are the generic sources for piroxicam and what is the scope of freedom to operate?

Piroxicam is the generic ingredient in two branded drugs marketed by Pfizer, Breckenridge, Cycle, Egis, Flamingo Pharms, Hikma, Ivax Sub Teva Pharms, Micro Labs, Mylan, Pharmobedient, SCS, Solis Pharms, Strides Pharma, Sun Pharm Industries, Teva, Teva Pharms, Unichem, Watson Labs, and Zydus Lifesciences, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for piroxicam. Nine suppliers are listed for this compound.

Summary for PIROXICAM

US Patents:	0
Tradenames:	2
Applicants:	19
NDAs:	23
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	34
Drug Prices:	Drug price trends for PIROXICAM
Drug Sales Revenues:	Drug sales revenues for PIROXICAM
What excipients (inactive ingredients) are in PIROXICAM?	PIROXICAM excipients list
DailyMed Link:	PIROXICAM at DailyMed

See drug prices for PIROXICAM

See drug sales revenues for PIROXICAM

Recent Clinical Trials for PIROXICAM

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

Sponsor	Phase
RANA AHMAD	PHASE4
University of Oklahoma	PHASE4
Phenikaa University	PHASE3

See all PIROXICAM clinical trials

Pharmacology for PIROXICAM

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for PIROXICAM

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PIROXICAM

M01AC	Oxicams
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for PIROXICAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	PIROXICAM	piroxicam	CAPSULE;ORAL	074043-002	Sep 22, 1992		DISCN	No	No
Strides Pharma	PIROXICAM	piroxicam	CAPSULE;ORAL	210347-001	Jan 26, 2018	AB	RX	No	No
Ivax Sub Teva Pharms	PIROXICAM	piroxicam	CAPSULE;ORAL	074148-001	Jun 3, 1996		DISCN	No	No
Teva	PIROXICAM	piroxicam	CAPSULE;ORAL	074131-001	Dec 11, 1992	AB	RX	No	No
Teva	PIROXICAM	piroxicam	CAPSULE;ORAL	074131-002	Dec 11, 1992	AB	RX	No	No
Strides Pharma	PIROXICAM	piroxicam	CAPSULE;ORAL	210347-002	Jan 26, 2018	AB	RX	No	No

Expired US Patents for PIROXICAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982	RE29668
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982	3,862,319
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982	3,591,564
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982	3,591,584
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982	3,674,876
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982	RE29668

Market Dynamics and Financial Trajectory for Piroxicam: A Comprehensive Analysis

Last updated: January 6, 2026

Summary

Piroxicam, a non-steroidal anti-inflammatory drug (NSAID) introduced in the 1980s, has historically played a significant role in managing pain and inflammation associated with conditions like rheumatoid arthritis and osteoarthritis. Despite its longstanding presence, its market trajectory faces challenges from newer NSAIDs, evolving regulatory landscapes, and changing prescriber preferences. This report examines the current market landscape for piroxicam, analyzing demand drivers, competitive positioning, regulatory influences, and financial forecasts. It further explores emerging trends and assesses future revenue potential within global markets, providing insights for stakeholders considering investment or strategic development involving piroxicam.

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What are the Market Dynamics influencing Piroxicam?

1. Global Market Size and Segmentation

Parameter	Details
Estimated Global NSAID Market (2022)	USD 16.5 billion; projected CAGR 4.8% through 2027 (Source: Grand View Research)[1]
Piroxicam's Market Share	Approx. 5-10% within the NSAID segment, primarily in the chronic pain treatment space
Leading Regions	Europe (largest), North America, Asia-Pacific (growing demand)

2. Therapeutic Demand Drivers

• Chronic Pain Management: Rising prevalence of osteoarthritis and rheumatoid arthritis (RA) fuels demand.
• Elderly Population: Aging demographics correlate with increased NSAID prescriptions, notably in Europe and North America.
• Prescriber Preference Trends: Continued reliance on older NSAIDs like piroxicam in certain markets due to established efficacy and cost factors.

3. Competitive Landscape

Competitors	Market share (%)	Notable Features
Celecoxib (Celebrex)	~15%	COX-2 selective NSAID, offers lower GI risk
Meloxicam	~10%	Tends towards COX-2 selectivity
Diclofenac and Ibuprofen	Combine ~25-30%	Widely generic, lower cost, broad availability
Piroxicam	5-10%	Long half-life, once-daily dosing, established but declining preference

4. Regulatory and Safety Profiles Impact

• Black-Box Warnings: Piroxicam carries warnings for gastrointestinal (GI) bleeding and cardiovascular risks, limiting its use to specific patient groups.
• Generic Status: Widely available as a generic, exerting downward pressure on prices.
• Market Approval Variability: Less favored in North America due to safety concerns, more prevalent in select European markets with broader prescribing practices.

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Financial Trajectory of Piroxicam

1. Revenue Estimations and Trends

Year	Estimated Global Revenue (USD Millions)	Key Notes
2018	USD 150 – 200	Dominated by legacy markets; declining due to safety concerns and generics
2020	USD 120 – 180	Impact from COVID-19 disruptions; increased NSAID competition
2022	USD 100 – 150	Continued decline, but stable in certain regions with brand loyalty
2027 (Projected)	USD 80 – 120	Estimated decline rate: ~4% annually; potential stabilization with niche applications

2. Factors Influencing Revenue

Factor	Impact
Competition from Novel NSAIDs	Intensifying, pressuring piroxicam's market share
Safety Concerns and Litigation	Risk of adverse effect litigation deters prescriptions
Regulatory Restrictions	Stricter prescribing guidelines, especially in North America and parts of Europe
Cost-effectiveness and Generics	Price erosion, though advantageous for cost-sensitive markets

3. Pricing Dynamics

Region	Average Retail Price (USD/tablet)	Trend
North America	USD 0.20 – 0.50	Declining, driven by generics
Europe	USD 0.15 – 0.40	Slight stabilization with brand loyalty in limited markets
Asia-Pacific	USD 0.05 – 0.20	Competitive, growing access

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What Are the Emerging Trends and Future Market Opportunities?

1. Niche and Combination Therapies

• Potential for Combination Drugs: Incorporating piroxicam into fixed-dose combination therapies for improved compliance.
• Localized Delivery Systems: Development of topical formulations or transdermal patches to mitigate systemic side effects.

2. Geographic Expansion

• Expanding in Developing Markets: Increased access and affordability in Asia, Latin America, and Africa could provide incremental revenue streams.
• Regulatory Strategies: Engaging with regulators to mitigate safety concerns through labeling and risk management.

3. Differentiation Through Safety Profiles

• Risk Management Programs: Companies might develop safer formulations or biomarkers for patient selection.
• Prescription Optimization: Emphasizing short-term use and patient education to address safety warnings.

4. Digital and Telemedicine Integration

• Utilizing digital tools for prescribing, monitoring, and patient adherence strategies, especially in remote and underserved regions.

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Comparison with Other NSAIDs: Positioning Piroxicam

Parameter	Piroxicam	Celecoxib	Meloxicam	Diclofenac
Mechanism	Non-selective NSAID	COX-2 selective	Preferential COX-2 inhibitor	Non-selective NSAID
Half-life	~50 hours	11 hours	15-20 hours	1-2 hours
Dosing Frequency	Once daily	Once daily	Once daily	Multiple times per day
Side Effect Profile	GI risk, cardiovascular risk	Lower GI but CV risk concerns	Lower GI risk	GI and CV risks
Regulatory Status	Widely used in Europe; restricted in North America	Approved globally	Widely used globally	Widely used (over the counter in many regions)
Market Share (2022)	5-10%	~15%	~10%	~20-25%

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Regulatory and Policy Environment Impact

Region	Key Policies Affecting Piroxicam	Impact
North America	FDA warnings, black-box labels, restricted indications	Reduced prescribing, declining revenues
Europe	Permitted with caution; some countries restrict long-term use	Maintaining niche markets
Asia-Pacific	Less restrictive, growing acceptance for chronic pain management	Growth opportunity

Regulatory Updates (2022-2023)

• FDA: Continued warnings against long-term use due to CV risks.
• EMA: Similar contraindications but permits short-term use.
• Local Policies: Some countries restrict OTC access, favoring prescription sales.

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Deep Dive: Market Forecasting and Strategic Insights

Forecast Parameter	Projection
Compound Annual Growth Rate (2022-2027)	-3% to -4%
Market Stabilization Opportunities	Limited to niche markets, institutional use, and alternative formulations
Potential Resurgence	Unlikely without significant safety innovations or new indications

Investment Considerations

• Risk: Declining revenues due to safety concerns and generic competition.
• Opportunity: Niche applications, off-label uses, and formulation innovations.
• Partnerships: Collaborations for clinical research to expand indications or improve safety.

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Key Takeaways

• Piroxicam’s global market has experienced consistent decline driven by safety concerns, patent expiry, and competitive NSAID landscape.
• Revenue projections show a continued downward trend, averaging a 3-4% annual decline, with potential stabilization in select European markets.
• Opportunities lie in developing safer formulations, expanding geographic presence in emerging markets, and leveraging combination therapies.
• Competition primarily from COX-2 selective agents limits piroxicam’s appeal, especially in regions with strict safety regulations.
• Regulatory policies globally favor NSAID safety, constraining long-term or high-dose use of piroxicam, necessitating innovative marketing and formulation strategies.

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Frequently Asked Questions (FAQs)

1. What factors have most contributed to the market decline of piroxicam?
Safety concerns regarding gastrointestinal and cardiovascular risks, along with the availability of newer, more selective NSAIDs, have significantly reduced piroxicam's market share. Additionally, patent expiry and price erosion due to generics further contributed to declining revenues.

2. Are there any upcoming formulations or indications for piroxicam?
Currently, no major new formulations or indications are in late-stage development. However, some research explores topical formulations or combination therapies aimed at reducing systemic side effects, representing potential future avenues.

3. How does regulatory oversight impact piroxicam's global sales?
Regulatory agencies such as the FDA and EMA have issued warnings and restrictions, particularly concerning long-term and high-dose use. These policies restrict prescribing practices, impacting sales especially in North America and parts of Europe.

4. Which regions hold the most potential for piroxicam’s niche growth?
Developing countries in Asia-Pacific and Latin America represent opportunities due to increasing access to affordable NSAIDs and evolving healthcare infrastructures. Regulatory flexibility and lower competition in such markets can facilitate growth.

5. How does the safety profile of piroxicam compare to other NSAIDs?
Piroxicam has a higher association with gastrointestinal bleeding and cardiovascular events compared to selective COX-2 inhibitors and some other NSAIDs, making it less preferred in regions with strict safety standards.

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References

[1] Grand View Research. (2022). NSAID Market Size, Share & Trends Analysis Report.