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, Norvium Bioscience, Nostrum Labs Inc, SCS, 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. Thirteen 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:	13
Raw Ingredient (Bulk) Api Vendors:	160
Clinical Trials:	28
Patent Applications:	8,043
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
University of Monastir	Phase 2
Mansoura University	Phase 2
Farjad Zafar	Phase 4

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
Micro Labs	PIROXICAM	piroxicam	CAPSULE;ORAL	206152-001	Dec 29, 2017	AB	RX	No	No
Ivax Sub Teva Pharms	PIROXICAM	piroxicam	CAPSULE;ORAL	074148-002	Jun 3, 1996		DISCN	No	No
Breckenridge	PIROXICAM	piroxicam	CAPSULE;ORAL	208991-002	Feb 21, 2018		DISCN	No	No
Nostrum Labs Inc	PIROXICAM	piroxicam	CAPSULE;ORAL	074118-002	Jun 15, 1993	AB	RX	No	No
Ivax Sub Teva Pharms	PIROXICAM	piroxicam	CAPSULE;ORAL	074148-001	Jun 3, 1996		DISCN	No	No
Watson Labs	PIROXICAM	piroxicam	CAPSULE;ORAL	074460-002	Sep 29, 1995		DISCN	No	No
Strides Pharma	PIROXICAM	piroxicam	CAPSULE;ORAL	210347-001	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
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982

PIROXICAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Piroxicam

Overview of Piroxicam

Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) widely used for the treatment of musculoskeletal disorders, including osteoarthritis, rheumatoid arthritis, and other inflammatory conditions. Here’s a detailed look at the market dynamics and financial trajectory of piroxicam.

Market Size and Growth

The global piroxicam market has been experiencing significant growth. As of 2023, the market size was valued at USD 3.09 billion and is projected to reach USD 4.84 billion by 2031, growing at a compound annual growth rate (CAGR) of 4.8% from 2024 to 2031[4].

Regional Analysis

The market is segmented into several key regions, including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. North America and Asia Pacific are among the largest regions, with North America accounting for a substantial share of the global musculoskeletal disorders drugs market, including piroxicam[5].

Competitive Landscape

The piroxicam market is competitive, with several key players such as Teva and Nostrum focusing on strategies to strengthen their product portfolios and expand their global presence. These companies are involved in various activities including new product launches, expansions, mergers & acquisitions, and partnerships to maintain their market share[1].

Market Segmentation

The market is segmented by type and application. The Type I segment of piroxicam accounted for a noticeable share of the global market in 2023 and is expected to experience significant growth in the near future. The Application 1 segment, which includes the treatment of osteoarthritis and other musculoskeletal disorders, is also expected to expand at a significant CAGR throughout the forecast period[1].

Economic Evaluations and Cost-Effectiveness

Economic evaluations have shown that piroxicam, while effective, has higher risks of serious gastrointestinal complications compared to other NSAIDs. A study in Spain found that restricting the use of piroxicam resulted in significant economic savings and a reduction in adverse drug reactions. The intervention saved 0.81 euros per treated patient and avoided 2.75 cases of serious gastrointestinal complications per 10,000 patients, leading to total savings of 578,608 euros in the first year[2].

In another study comparing meloxicam with diclofenac and piroxicam in the UK, meloxicam was found to be the most cost-effective option for treating osteoarthritis. Meloxicam had the lowest cost per patient and resulted in fewer serious adverse events, leading to cost savings of over £25 million per annum if patients were switched from piroxicam and diclofenac to meloxicam[3].

Regulatory and Pharmacovigilance Aspects

Regulatory interventions play a crucial role in the market dynamics of piroxicam. The Spanish Agency for Medicines and Medical Devices (AEMPS) intervention on piroxicam is a prime example, where regulatory actions not only prevented adverse drug reactions but also resulted in economic savings[2].

Technological and Market Trends

The musculoskeletal disorders drugs market, including piroxicam, is influenced by technological advancements and market trends. The rise in combination therapy, where multiple medications are used to treat a disease, is expected to increase the demand for muscle relaxants and other musculoskeletal disorder drugs. Additionally, regulatory changes such as the European Union's General Data Protection Regulation (GDPR) impact the market by increasing costs related to new product development and data protection[5].

Financial Performance of Key Players

Key players in the piroxicam market, such as Teva and Nostrum, focus on financial strategies to maintain their market share. These strategies include revenue growth, gross margin management, and market share expansion. The financial performance of these companies is closely tied to the overall market trends and regulatory environments[1].

SWOT Analysis

Strengths

• Established market presence and brand recognition.
• Wide range of applications in treating musculoskeletal disorders.
• Continuous research and development to improve safety and efficacy.

Weaknesses

• Higher risk of serious gastrointestinal complications compared to other NSAIDs.
• Dependence on regulatory approvals and compliance.

Opportunities

• Growing demand for musculoskeletal disorder treatments.
• Potential for combination therapies.
• Expanding into new markets and regions.

Threats

• Regulatory changes and stringent approval processes.
• Competition from other NSAIDs and COX-2 inhibitors.
• Economic pressures and cost containment measures.

Market Attractiveness and Forecast

The global piroxicam market is expected to remain attractive due to the growing prevalence of musculoskeletal disorders and the need for effective treatments. The market forecast indicates steady growth, driven by increasing demand and advancements in healthcare technologies. However, the market will need to navigate regulatory challenges and competition from other therapeutic options[4].

Key Takeaways

• The global piroxicam market is valued at USD 3.09 billion in 2023 and is expected to grow to USD 4.84 billion by 2031.
• The market is segmented by type and application, with significant growth expected in the Type I segment and Application 1 segment.
• Economic evaluations highlight the need for careful consideration of cost-effectiveness and safety.
• Regulatory interventions and pharmacovigilance play crucial roles in market dynamics.
• Key players focus on strengthening their product portfolios and expanding their global presence.

FAQs

Q: What is the current market size of piroxicam and its projected growth?

The global piroxicam market was valued at USD 3.09 billion in 2023 and is expected to reach USD 4.84 billion by 2031, growing at a CAGR of 4.8% from 2024 to 2031[4].

Q: Which regions are the largest markets for piroxicam?

North America and Asia Pacific are among the largest regions for the piroxicam market, with North America accounting for a significant share of the global musculoskeletal disorders drugs market[5].

Q: What are the key challenges faced by the piroxicam market?

The market faces challenges such as higher risks of serious gastrointestinal complications, regulatory changes, and competition from other NSAIDs and COX-2 inhibitors[2][3].

Q: How do regulatory interventions impact the piroxicam market?

Regulatory interventions can significantly impact the market by affecting the safety profile and cost-effectiveness of piroxicam. For example, the Spanish Agency for Medicines and Medical Devices intervention resulted in economic savings and reduced adverse drug reactions[2].

Q: What are the future trends expected in the piroxicam market?

Future trends include the rise in combination therapy, increased focus on pharmacovigilance, and the impact of regulatory changes such as GDPR on new product development and data protection[5].

Sources

1. Cognitivemarketresearch.com: Piroxicam Market Report 2024 (Global Edition)
2. PubMed: Economic evaluation of the restriction in the use piroxicam in Spain
3. PubMed: An economic evaluation of meloxicam versus diclofenac and piroxicam
4. Marketresearchintellect.com: Piroxicam Market Size, Share, Growth & Trends [2024-2031]
5. Globenewswire.com: $81 Billion Worldwide Musculoskeletal Disorders Drugs Industry to 2030