Oxaprozin - Generic Drug Details

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

Oxaprozin is the generic ingredient in four branded drugs marketed by Solubiomix, Pfizer, Abraxeolus, Actavis Elizabeth, Amneal Pharms Co, Beximco Pharms Usa, Chartwell, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan Pharms Inc, Norvium Bioscience, Sandoz, Sun Pharm Inds Inc, Teva, and Watson Labs, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for oxaprozin. Twelve suppliers are listed for this compound.

Summary for oxaprozin

US Patents:	0
Tradenames:	4
Applicants:	15
NDAs:	16
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	3
Patent Applications:	6,906
Drug Prices:	Drug price trends for oxaprozin
What excipients (inactive ingredients) are in oxaprozin?	oxaprozin excipients list
DailyMed Link:	oxaprozin at DailyMed

See drug prices for oxaprozin

See drug sales revenues for oxaprozin

Recent Clinical Trials for oxaprozin

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

Sponsor	Phase
Fuji Yakuhin Co., Ltd.	Phase 1
Mochida Pharmaceutical Company, Ltd.	Phase 1
Federal University of São Paulo	Phase 4

See all oxaprozin clinical trials

Pharmacology for oxaprozin

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

Anatomical Therapeutic Chemical (ATC) Classes for oxaprozin

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

US Patents and Regulatory Information for oxaprozin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	OXAPROZIN	oxaprozin	TABLET;ORAL	075848-001	Feb 9, 2001		DISCN	No	No
Teva	OXAPROZIN	oxaprozin	TABLET;ORAL	075849-001	Jul 3, 2002		DISCN	No	No
Actavis Elizabeth	OXAPROZIN	oxaprozin	TABLET;ORAL	075843-001	Oct 3, 2001		DISCN	No	No

Oxaprozin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxaprozin

Introduction

Oxaprozin, a non-steroidal anti-inflammatory drug (NSAID), has been a significant player in the treatment of painful rheumatic and inflammatory conditions since its approval in 1992. Here, we delve into the market dynamics and financial trajectory of oxaprozin, exploring its current market status, growth drivers, and financial performance.

Market Size and Growth

The oxaprozin market is anticipated to experience substantial growth in the coming years. As of 2023, the market size was evaluated at approximately USD 1.2 billion and is expected to grow with a compound annual growth rate (CAGR) of 4.5%[1].

Key Drivers of Growth

Several factors are driving the growth of the oxaprozin market:

Rising Prevalence of Arthritis and Musculoskeletal Disorders

The increasing prevalence of arthritis and musculoskeletal disorders is a significant driver. As the global population ages, the demand for effective pain relief solutions like oxaprozin is on the rise[4].

Convenience of Administration

Oxaprozin offers the convenience of once-daily administration, which is a major advantage over other NSAIDs that require more frequent dosing. This convenience enhances patient compliance and satisfaction[3].

Efficacy and Tolerability

Clinical data suggest that oxaprozin is comparable in effectiveness to other NSAIDs like aspirin, ibuprofen, and naproxen in treating rheumatoid arthritis and osteoarthritis. Additionally, oxaprozin has been shown to produce fewer gastrointestinal side effects than aspirin, making it a preferred option for many patients[3].

Financial Performance

Historical Context

In the past, the launch of generic versions of oxaprozin and other NSAIDs has significantly impacted the financial performance of pharmaceutical companies. For instance, Dr. Reddy’s Laboratories saw a substantial increase in revenues from their North American generics business, including the launch of generic versions of NSAIDs, which contributed significantly to their financial growth[2].

Current Market

The current market for oxaprozin is characterized by a mix of branded and generic products. The approval of new formulations, such as the 300 mg capsules under the proprietary name Coxanto, has expanded the market offerings and potentially increased revenue streams[5].

Competitive Landscape

The competitive landscape for oxaprozin includes both innovator products and generic versions. The original innovator product, Daypro, has been available since 1992, and subsequent generic versions have entered the market. The recent approval of Coxanto (oxaprozin 300 mg capsules) adds another layer to the competitive landscape, offering a smaller dosing increment which could attract more patients[5].

Geographic Market Mix

The market for oxaprozin is not limited to a single region but is spread globally. International revenues play a significant role, with markets outside the U.S. contributing substantially to the overall revenue. For example, international revenues accounted for a significant portion of the API and formulations revenues for companies like Dr. Reddy’s Laboratories[2].

Risks and Challenges

Safety Profile

While oxaprozin has a favorable safety profile compared to other NSAIDs, it still carries the typical risks associated with NSAIDs, such as cardiovascular thrombotic events, gastrointestinal adverse events, and renovascular adverse effects. These risks are mitigated through careful dosing and monitoring[5].

Regulatory Considerations

Regulatory approvals and compliance are crucial for the financial trajectory of oxaprozin. The FDA's approval of new formulations and the ongoing monitoring of safety data ensure that the product remains safe and effective for patients. The elimination of the loading dose option for Coxanto to mitigate the first-dose Cmax issue is an example of regulatory oversight[5].

Financial Projections

Given the current market dynamics, the oxaprozin market is expected to continue its growth trajectory. With a projected CAGR of 4.5%, the market is anticipated to reach significant milestones in the coming years. This growth will be driven by increasing demand, new product launches, and the expanding global reach of oxaprozin[1].

Key Takeaways

• The oxaprozin market is expected to grow with a CAGR of 4.5%, driven by the rising prevalence of arthritis and musculoskeletal disorders.
• Oxaprozin offers once-daily administration, which enhances patient compliance and satisfaction.
• The drug has a favorable efficacy and tolerability profile compared to other NSAIDs.
• The competitive landscape includes both innovator and generic products, with new formulations like Coxanto expanding market offerings.
• Regulatory compliance and safety monitoring are crucial for maintaining the product's safety and effectiveness.

FAQs

What is oxaprozin used for?

Oxaprozin is used for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis[5].

What are the key benefits of oxaprozin?

Oxaprozin offers once-daily administration, fewer gastrointestinal side effects compared to aspirin, and comparable efficacy to other NSAIDs[3].

What are the risks associated with oxaprozin?

The key risks include cardiovascular thrombotic events, gastrointestinal adverse events, and renovascular adverse effects, which are typical for NSAIDs[5].

How is the oxaprozin market expected to grow?

The oxaprozin market is expected to grow with a CAGR of 4.5%, driven by increasing demand and new product launches[1].

What is the current market size of oxaprozin?

As of 2023, the oxaprozin market size was approximately USD 1.2 billion[1].

Sources

1. Dataintelo: Oxaprozin Market Research Report 2032.
2. Annual Reports: BUILDING BLOCKS OF GROWTH - Annual Reports.
3. PubMed: Oxaprozin. A preliminary review of its pharmacodynamic.
4. Market Research Intellect: Oxaprozin - Market Research Intellect.
5. FDA: Coxanto (Oxaprozin) - FDA.