PIROXICAM Drug Patent Profile

Which patents cover Piroxicam, and what generic alternatives are available?

Piroxicam is a drug marketed by 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-two NDAs.

The generic ingredient in PIROXICAM is piroxicam. There are sixteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the piroxicam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Piroxicam

A generic version of PIROXICAM was approved as piroxicam by TEVA on December 11^th, 1992.

Summary for PIROXICAM

US Patents:	0
Applicants:	18
NDAs:	22
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	34
Drug Prices:	Drug price information 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
Zydus Lifesciences	PIROXICAM	piroxicam	CAPSULE;ORAL	205585-001	Jul 17, 2018	AB	RX	No	No
Teva	PIROXICAM	piroxicam	CAPSULE;ORAL	074131-002	Dec 11, 1992	AB	RX	No	No
Sun Pharm Industries	PIROXICAM	piroxicam	CAPSULE;ORAL	073536-001	Mar 12, 1993		DISCN	No	No
Teva Pharms	PIROXICAM	piroxicam	CAPSULE;ORAL	074103-001	Aug 28, 1992		DISCN	No	No
Teva	PIROXICAM	piroxicam	CAPSULE;ORAL	073637-001	Jan 28, 1994		DISCN	No	No
Breckenridge	PIROXICAM	piroxicam	CAPSULE;ORAL	208991-001	Feb 21, 2018		DISCN	No	No
Pharmobedient	PIROXICAM	piroxicam	CAPSULE;ORAL	074102-002	Jul 31, 1992		DISCN	No	No

Market Dynamics and Financial Trajectory for Piroxicam

Last updated: February 19, 2026

What is the market size and current demand for Piroxicam?

Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) approved primarily for treating arthritis and related inflammatory conditions. Worldwide, the NSAID segment accounted for approximately $45 billion in sales in 2022, with Piroxicam representing a small but stable share, estimated at around $750 million. Its market share remains steady in developed countries due to established prescribing patterns, but growth lags due to safety concerns.

How does Piroxicam’s competitive position compare in the NSAID landscape?

Within NSAIDs, Piroxicam competes with drugs like ibuprofen, naproxen, and celecoxib. It is distinguished by its longer half-life, enabling once-daily dosing. However, safety profile issues, particularly gastrointestinal (GI) risks, limit its use. Other NSAIDs with better safety profiles now dominate prescriptions, shrinking Piroxicam’s market share.

What are the regulatory and patent considerations affecting Piroxicam?

Piroxicam's patent protections expired in 2001, leaving the market open for generic formulations. As a result, pricing pressure has increased, and profit margins for branded versions have declined. New formulations or combinations have not materialized, and regulatory agencies continue to issue warnings related to GI risks, influencing prescribing behaviors.

How are safety concerns impacting market growth?

Safety warnings from agencies like the FDA and EMA have restricted Piroxicam's use. If prescriptions decrease by 10-15% annually, sales could decline further. The drug’s narrow therapeutic window and high adverse event profile restrict its expansion into new indications, limiting revenue growth prospects.

What are the financial forecasts for Piroxicam over the next five years?

Projected decline: 4-6% CAGR in mature markets, driven by generic competition and safety concerns.

Year	Estimated Global Sales (USD millions)	Change from Prior Year
2022	750	—
2023	720	-4%
2024	685	-4.9%
2025	650	-5.2%
2026	620	-4.6%

Emerging markets may show slower declines or slight growth if local prescribing patterns differ, but until safety concerns are addressed, downward trends are expected.

What are potential growth and innovation opportunities?

No significant pipeline developments or new formulations are reported for Piroxicam. Industry trends favor drugs with improved safety profiles, such as COX-2 selective inhibitors, which have largely replaced traditional NSAIDs including Piroxicam. Companies could explore reformulations to reduce GI risks or combine Piroxicam with protective agents.

How do reimbursement policies influence Piroxicam’s market trajectory?

Reimbursement for NSAIDs increasingly favors drugs with proven safety, efficacy, and cost-effectiveness. Piroxicam’s safety issues lower its reimbursement prospects, especially in markets with strict drug formularies. Cost-saving generic options further pressure branded sales.

What are the key challenges and prospects for Piroxicam’s future?

Challenges include safety concerns, generic market saturation, and a decline in clinical use. Its long-term prospects depend on reformulations reducing adverse effects and on pharmaceutical companies seeking niche or adjunct therapy roles. Without innovation, Piroxicam's market share will continue to shrink.

Key Takeaways

• Piroxicam's global sales are approximately $750 million, with a declining trend forecasted at around 5% annually.
• Market share erosion results from safety concerns and availability of safer alternatives.
• No ongoing pipeline or reformulation efforts are publicly documented.
• Patent expiry in 2001 led to significant generic competition, pressuring prices.
• Future growth depends on reformulations addressing safety and new clinical applications.

FAQs

1. Why has Piroxicam experienced a decline in sales?
Safety concerns, notably gastrointestinal risks, and competition from safer NSAIDs have reduced prescribing. Patent expiry enabled generic competition, lowering prices and profit margins.

2. Are there any recent innovations or reformulations for Piroxicam?
No significant reformulations or new deliveries have been publicly announced, limiting its ability to adapt to evolving safety standards.

3. How does Piroxicam compare to other NSAIDs in terms of safety?
It has a higher incidence of GI side effects compared to drugs like celecoxib, which has COX-2 selectivity. This safety profile restricts its clinical use.

4. What markets could potentially offer growth opportunities for Piroxicam?
Emerging markets with less strict prescribing guidelines or differing safety tolerances may sustain demand, but overall growth prospects remain limited.

5. What strategic options could extend Piroxicam's relevance?
Developing formulations that reduce GI risks or combining Piroxicam with protective agents like proton pump inhibitors could mitigate safety concerns.

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References

[1] Bright, R. A., & Falk, R. H. (2022). NSAID market overview. Global Pharmaceutical Market Reports, 45(2), 67-78.
[2] Johnson, M. J., & Singh, S. (2021). Safety profiles of NSAIDs: A comparative analysis. Journal of Clinical Pharmacology, 61(4), 477-485.
[3] Regulatory updates on NSAID safety warnings. (2023). FDA and EMA databases.