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Last Updated: January 5, 2025

ORUVAIL Drug Patent Profile


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

Oruvail is a drug marketed by Wyeth Pharms Inc and is included in one NDA.

The generic ingredient in ORUVAIL is ketoprofen. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ketoprofen profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Oruvail

A generic version of ORUVAIL was approved as ketoprofen by TEVA on December 22nd, 1992.

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Summary for ORUVAIL
Drug patent expirations by year for ORUVAIL
Recent Clinical Trials for ORUVAIL

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

SponsorPhase
University of RochesterPhase 2/Phase 3
Mae Stone Goode FoundationPhase 2/Phase 3
Sanford ResearchEarly Phase 1

See all ORUVAIL clinical trials

US Patents and Regulatory Information for ORUVAIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Pharms Inc ORUVAIL ketoprofen CAPSULE, EXTENDED RELEASE;ORAL 019816-003 Feb 8, 1995 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Pharms Inc ORUVAIL ketoprofen CAPSULE, EXTENDED RELEASE;ORAL 019816-002 Feb 8, 1995 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Pharms Inc ORUVAIL ketoprofen CAPSULE, EXTENDED RELEASE;ORAL 019816-001 Sep 24, 1993 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ORUVAIL Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Oruvail

Introduction to Oruvail

Oruvail, a non-steroidal anti-inflammatory drug (NSAID), is primarily used in the management of various musculoskeletal and inflammatory conditions. It contains ketoprofen, a potent anti-inflammatory and analgesic agent, and is available in prolonged-release capsules.

Therapeutic Indications

Oruvail is recommended for the treatment of several conditions, including rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute articular and periarticular disorders, cervical spondylitis, low back pain, gout, and dysmenorrhoea. It also helps in controlling pain and inflammation following orthopaedic surgery[1][4].

Market Demand

The demand for NSAIDs like Oruvail is driven by the prevalence of chronic pain and inflammatory conditions. With an aging population and increasing incidence of conditions such as osteoarthritis and rheumatoid arthritis, the market for these drugs remains robust.

Prevalence of Target Conditions

  • Osteoarthritis: Affects millions worldwide, with the prevalence expected to increase due to the aging population.
  • Rheumatoid Arthritis: Another significant market driver, with a global prevalence that underscores the ongoing need for effective treatments.
  • Other Conditions: Conditions like ankylosing spondylitis, gout, and dysmenorrhoea also contribute to the demand for Oruvail[1][4].

Competitive Landscape

The NSAID market is highly competitive, with numerous brands and generic options available. Oruvail competes with other NSAIDs and newer classes of drugs that target similar conditions.

Key Competitors

  • Other NSAIDs: Drugs like ibuprofen, naproxen, and diclofenac are widely used alternatives.
  • Biologics and DMARDs: For conditions like rheumatoid arthritis, biologics and disease-modifying antirheumatic drugs (DMARDs) are increasingly popular, offering a more targeted approach to treatment[1][4].

Pricing and Reimbursement

The pricing of Oruvail is influenced by several factors, including the cost of production, market competition, and reimbursement policies.

Pricing Strategy

  • List Price: The list price of Oruvail is generally in line with other NSAIDs, although it may vary by region and market.
  • Reimbursement: In many countries, Oruvail is covered by health insurance plans, which helps in maintaining its market share. However, the extent of coverage can vary[1][4].

Financial Performance

While specific financial data for Oruvail is not readily available, we can infer some financial dynamics from the broader pharmaceutical market and the performance of similar drugs.

Revenue Streams

  • Prescription Sales: The primary revenue stream for Oruvail comes from prescription sales. The drug's efficacy and the breadth of its indications contribute to its revenue.
  • Market Penetration: Oruvail's market penetration is influenced by its brand recognition, marketing efforts, and the prescribing habits of healthcare professionals[1][4].

Challenges and Risks

Adverse Effects and Safety Concerns

Oruvail, like other NSAIDs, is associated with several adverse effects, including gastrointestinal bleeding, cardiovascular risks, and renal impairment. These risks can impact its market performance and financial trajectory.

  • Gastrointestinal Risks: Elderly patients are particularly at risk, and the use of the lowest effective dose for the shortest duration is recommended to minimize these risks[1][4].
  • Cardiovascular Risks: High doses and long-term use of NSAIDs, including Oruvail, have been linked to an increased risk of arterial thrombotic events such as myocardial infarction and stroke[1].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of any pharmaceutical product. Changes in regulations or safety guidelines can significantly impact sales.

  • Reporting Adverse Reactions: Healthcare professionals are required to report any suspected adverse reactions, which helps in continuous monitoring of the drug's safety profile[1].

Future Outlook

The future outlook for Oruvail is influenced by several factors, including the evolution of treatment options for its target conditions and changes in market dynamics.

Emerging Treatments

  • Biologics and New Therapies: The development of biologics and other targeted therapies may reduce the market share of traditional NSAIDs like Oruvail.
  • Generic Competition: The potential for generic versions of Oruvail could also impact its revenue as generics often offer a cheaper alternative[1][4].

Market Expansion

  • Global Markets: Expanding into new markets, especially in regions with growing healthcare needs, could provide opportunities for growth.
  • Diversification: Diversifying the product portfolio to include other therapeutic areas or formulations could help mitigate risks associated with a single product[1][4].

Key Takeaways

  • Therapeutic Indications: Oruvail is used for a wide range of musculoskeletal and inflammatory conditions.
  • Market Demand: Driven by the prevalence of chronic pain and inflammatory conditions.
  • Competitive Landscape: Highly competitive with other NSAIDs and newer classes of drugs.
  • Pricing and Reimbursement: Influenced by production costs, competition, and reimbursement policies.
  • Financial Performance: Revenue primarily from prescription sales, with challenges from adverse effects and regulatory changes.
  • Future Outlook: Influenced by emerging treatments, generic competition, and market expansion opportunities.

FAQs

What are the primary therapeutic indications for Oruvail?

Oruvail is indicated for the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute articular and periarticular disorders, cervical spondylitis, low back pain, gout, and dysmenorrhoea, as well as for controlling pain and inflammation following orthopaedic surgery[1][4].

What are the potential adverse effects of Oruvail?

Oruvail can cause gastrointestinal bleeding, cardiovascular risks, renal impairment, and other adverse effects. Elderly patients are at increased risk of serious consequences from these adverse reactions[1][4].

How does Oruvail compare to other NSAIDs in the market?

Oruvail competes with other NSAIDs like ibuprofen, naproxen, and diclofenac. Its market share is influenced by its efficacy, safety profile, and prescribing habits of healthcare professionals[1][4].

What is the impact of generic competition on Oruvail?

The potential for generic versions of Oruvail could reduce its revenue as generics often offer a cheaper alternative, which could attract price-sensitive consumers and healthcare providers[1][4].

How does the regulatory environment affect Oruvail's financial trajectory?

Changes in regulations or safety guidelines can significantly impact sales. Continuous monitoring of adverse reactions and compliance with regulatory requirements are crucial for maintaining market presence[1].

Sources

  1. Medicines.org.uk: Oruvail 200mg Capsules - Summary of Product Characteristics.
  2. Oruka Therapeutics: Third Quarter 2024 Financial Results (Note: This source is not directly related to Oruvail but provides context on pharmaceutical market dynamics).
  3. Baron Capital Group: A Multi-Billion-Dollar Drug Market (Note: This source is not directly related to Oruvail but provides context on pharmaceutical market dynamics).
  4. Medsafe: Oruvail SR 200 mg capsules - New Zealand Data Sheet.
  5. GlobeNewswire: Oruka Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update (Note: This source is not directly related to Oruvail but provides context on pharmaceutical market dynamics).

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