ORUDIS Drug Patent Profile

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

Orudis is a drug marketed by Wyeth Ayerst and Wyeth Cons and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Orudis

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

Summary for ORUDIS

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	2
DailyMed Link:	ORUDIS at DailyMed

Recent Clinical Trials for ORUDIS

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

Sponsor	Phase
University of Rochester	Phase 2/Phase 3
Mae Stone Goode Foundation	Phase 2/Phase 3
Sanford Research	Early Phase 1

See all ORUDIS clinical trials

US Patents and Regulatory Information for ORUDIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	ORUDIS	ketoprofen	CAPSULE;ORAL	018754-001	Jul 31, 1987		DISCN	Yes	No
Wyeth Cons	ORUDIS KT	ketoprofen	TABLET;ORAL	020429-001	Oct 6, 1995		DISCN	Yes	No
Wyeth Ayerst	ORUDIS	ketoprofen	CAPSULE;ORAL	018754-002	Jan 9, 1986		DISCN	Yes	No
Wyeth Ayerst	ORUDIS	ketoprofen	CAPSULE;ORAL	018754-003	Jan 9, 1986		DISCN	Yes	No

Expired US Patents for ORUDIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Ayerst	ORUDIS	ketoprofen	CAPSULE;ORAL	018754-001	Jul 31, 1987
Wyeth Ayerst	ORUDIS	ketoprofen	CAPSULE;ORAL	018754-003	Jan 9, 1986
Wyeth Ayerst	ORUDIS	ketoprofen	CAPSULE;ORAL	018754-002	Jan 9, 1986

International Patents for ORUDIS

See the table below for patents covering ORUDIS around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	293365
Denmark	135572
Germany	1668648
Luxembourg	60059
Spain	374764
Yugoslavia	34656

ORUDIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Orudis (Ketoprofen)

Introduction

Orudis, known generically as ketoprofen, is a nonsteroidal anti-inflammatory drug (NSAID) widely used for treating pain, inflammation, swelling, stiffness, and joint pain. Here, we delve into the market dynamics and financial trajectory of ketoprofen, highlighting key drivers, challenges, and future outlook.

Market Drivers

Rising Demand for Pain Management

The global demand for effective pain management solutions is on the rise, driven by an increasing prevalence of chronic diseases and an aging population. Ketoprofen, with its efficacy in reducing inflammation and alleviating pain, is a crucial component in this landscape[3].

Increasing Geriatric Population

The growing geriatric population is a significant driver, as older adults are more prone to conditions such as arthritis, which ketoprofen is commonly used to treat[1].

Preference Over Opioids

There is a growing preference for NSAIDs like ketoprofen over opioids due to the lower risk of addiction and other adverse effects associated with opioid use. This shift further boosts the demand for ketoprofen[1].

Market Restraints

Side Effects and Safety Concerns

Despite its efficacy, ketoprofen is associated with several side effects, including gastrointestinal issues, cardiovascular risks, and potential bleeding in the stomach or intestines. These safety concerns can limit its market growth[2][3].

Regulatory Challenges

Regulatory hurdles and the need for continuous monitoring of side effects pose significant challenges. Regular blood and urine tests are necessary to check for unwanted effects, which can be a deterrent for some patients[2].

Alternative Therapies

The increasing preference for alternative therapies such as physiotherapy also presents a challenge to the market growth of ketoprofen[1].

Market Opportunities

Innovations in Drug Delivery

Advancements in drug delivery technologies, such as transdermal patches and sustained-release formulations, are enhancing the effectiveness and safety of ketoprofen. These innovations open new revenue streams and improve patient outcomes[3].

Personalized Medicine

The shift towards personalized medicine, where treatment plans are tailored to individual patients based on their genetic makeup, lifestyle, and environment, offers significant opportunities. This approach can maximize the efficacy of ketoprofen while minimizing side effects[3].

Combination Therapies

Exploring combination therapies to enhance the efficacy and safety of ketoprofen is another promising area. This could involve integrating ketoprofen with other medications to treat specific patient populations more effectively[1].

Market Challenges

Clinical Trial Failures

The failure of drugs during clinical trials is a significant challenge. Ensuring that new formulations of ketoprofen pass rigorous clinical trials is crucial for market success[1].

Competition and Market Saturation

The NSAID market is mature and highly competitive, with several established brands. Differentiating ketoprofen through innovative formulations and delivery methods is essential to maintain market share[1].

Financial Trajectory

Global Market Size

The global non-steroidal anti-inflammatory drugs market, which includes ketoprofen, is projected to grow significantly over the coming years. The market size is expected to increase driven by rising demand for pain management solutions and innovations in drug delivery technologies[1][3].

Regional Growth

Ketoprofen is widely adopted in both developed and developing regions. In developed countries, it is a staple in pain management protocols, while in emerging markets, growing awareness and increasing access to healthcare services are driving demand[3].

Revenue Streams

The market is expected to generate substantial revenue through various channels, including over-the-counter (OTC) sales and prescription medications. Innovations such as topical formulations and sustained-release products are expected to contribute significantly to revenue growth[1][3].

Key Trends

Precision Medicine

The trend towards precision medicine is transforming the way ketoprofen is used. By leveraging genetic information and patient data, pharmaceutical companies are developing targeted ketoprofen formulations that are more effective and safer[3].

Strategic Partnerships

Strategic partnerships between pharmaceutical companies and research institutions are fostering innovation. These collaborations lead to the development of next-generation ketoprofen products and enhance market penetration[3].

Regulatory Approvals

Recent regulatory approvals for new ketoprofen formulations are expected to boost market penetration and expand the range of available treatment options. Quick approvals by governments and increased government initiatives also support market growth[1][3].

Innovations and Technological Advancements

Nanotechnology

The use of nanotechnology in drug formulation is enhancing the effectiveness and safety of ketoprofen. This technology allows for more precise drug delivery, reducing side effects and improving patient outcomes[3].

Topical Formulations

Topical ketoprofen products, such as creams and gels, are gaining popularity due to their localized action and reduced systemic side effects. These formulations are particularly beneficial for patients with skin conditions or localized pain[3].

Conclusion

The market for Orudis (ketoprofen) is dynamic and influenced by several key factors. While the drug faces challenges such as side effects and regulatory hurdles, innovations in drug delivery, personalized medicine, and strategic partnerships are driving growth. The financial trajectory of ketoprofen is positive, with significant revenue potential through various channels.

Key Takeaways

• Rising Demand: Increasing global demand for pain management solutions drives the market.
• Innovations: Advancements in drug delivery technologies and personalized medicine enhance efficacy and safety.
• Regulatory Approvals: Quick approvals and government initiatives support market growth.
• Challenges: Side effects, regulatory challenges, and competition are significant hurdles.
• Financial Growth: The market is expected to grow substantially, driven by OTC and prescription sales.

FAQs

What are the primary uses of ketoprofen?

Ketoprofen is primarily used to treat pain, inflammation, swelling, stiffness, and joint pain, particularly in conditions such as arthritis, muscle pain, and menstrual discomfort[2][4].

What are the common side effects of ketoprofen?

Common side effects include headache, increased blood pressure, nausea, stomach pain, and swelling of the face, fingers, feet, or lower legs. More severe side effects can include gastrointestinal bleeding and cardiovascular risks[2].

How is the market for ketoprofen expected to grow?

The market is expected to grow significantly driven by rising global demand for pain management solutions, innovations in drug delivery technologies, and the shift towards personalized medicine[1][3].

What role do strategic partnerships play in the ketoprofen market?

Strategic partnerships between pharmaceutical companies and research institutions are crucial for driving innovation, leading to the development of next-generation ketoprofen products and enhancing market penetration[3].

How does nanotechnology impact the ketoprofen market?

Nanotechnology enhances the effectiveness and safety of ketoprofen by allowing for more precise drug delivery, reducing side effects, and improving patient outcomes[3].

Sources

1. Research and Markets: Non-steroidal Anti-inflammatory Drugs Market Size & Trends.
2. Mayo Clinic: Ketoprofen (oral route) - Mayo Clinic.
3. Market Research Intellect: Pharmaceutical Grade Ketoprofen Market Size And Projection.
4. PubMed: Ketoprofen: a review of its pharmacologic and clinical properties.