CLINORIL Drug Patent Profile

When do Clinoril patents expire, and when can generic versions of Clinoril launch?

Clinoril is a drug marketed by Merck and is included in one NDA.

The generic ingredient in CLINORIL is sulindac. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sulindac profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Clinoril

A generic version of CLINORIL was approved as sulindac by WATSON LABS on April 3^rd, 1990.

Summary for CLINORIL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	9
DailyMed Link:	CLINORIL at DailyMed

Recent Clinical Trials for CLINORIL

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

Sponsor	Phase
Cancer Prevention Pharmaceuticals, Inc.	Phase 3
Stony Brook University	Phase 2
Children's Oncology Group	Phase 2

See all CLINORIL clinical trials

US Patents and Regulatory Information for CLINORIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for CLINORIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-001	Approved Prior to Jan 1, 1982	3,654,349
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-002	Approved Prior to Jan 1, 1982	3,725,548
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-002	Approved Prior to Jan 1, 1982	3,654,349
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-001	Approved Prior to Jan 1, 1982	3,725,548

International Patents for CLINORIL

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

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	272175
Austria	333745
Yugoslavia	35234
Norway	135824
Israel	34998	INDENYL ACETIC ACIDS AND PROCESSES FOR PREPARING THEM
Spain	413266

CLINORIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CLINORIL

Introduction

CLINORIL, known generically as sulindac, is a non-steroidal anti-inflammatory drug (NSAID) that has been widely used for its anti-inflammatory, analgesic, and antipyretic properties. To understand the market dynamics and financial trajectory of CLINORIL, it is essential to delve into its clinical efficacy, market trends, and the broader pharmaceutical industry context.

Clinical Efficacy and Uses

CLINORIL has been evaluated in various clinical studies for its effectiveness in treating several conditions, including osteoarthritis, rheumatoid arthritis, and acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis)[1].

• Osteoarthritis: CLINORIL demonstrated significant improvements in joint mobility, range of motion, and functional activities, comparable to high doses of aspirin but with fewer adverse effects.
• Rheumatoid Arthritis: The drug showed reductions in joint pain, morning stiffness, and improvements in grip strength and spinal mobility.
• Acute Painful Shoulder: CLINORIL provided relief from night pain, spontaneous pain, and pain on active motion, along with improvements in range of motion.

Market Trends in NSAIDs

The market for NSAIDs, including CLINORIL, is influenced by several trends:

Generic Drug Competition

Generic versions of NSAIDs significantly impact the market. As more generic competitors enter the market, prices tend to fall, but they remain above long-run marginal costs until there are 8 or more competitors[4].

Specialty vs. Traditional Drugs

While traditional drug spending, including NSAIDs, has seen a decline due to high generic dispensing rates and price reductions, specialty drugs have become the largest cost drivers in the pharmaceutical market. However, CLINORIL, being a traditional NSAID, is more likely to be affected by the trends in traditional drug spending[3].

Pharmaceutical Benefit Managers (PBMs)

PBMs play a crucial role in managing drug spend. For traditional drugs like CLINORIL, PBMs often report declines in spending due to increased generic dispensing rates and unit cost decreases. This can impact the revenue generated by branded NSAIDs like CLINORIL[3].

Financial Trajectory

The financial performance of CLINORIL is tied to the broader trends in the pharmaceutical industry and the specific market dynamics of NSAIDs.

Revenue Impact

Given the rise of generic competition and the decline in traditional drug spending, the revenue from CLINORIL is likely to decrease over time. As more generic versions of sulindac enter the market, the price and market share of the branded version are expected to decline.

Cost and Pricing

The cost structure for CLINORIL includes manufacturing, marketing, and distribution expenses. With generic competition, the pricing strategy for CLINORIL would need to be adjusted to remain competitive. However, as seen in the generic drug industry, prices tend to fall significantly with increased competition[4].

Market Share

CLINORIL's market share is expected to diminish as generic alternatives become more prevalent. This is a common trend in the pharmaceutical industry where branded drugs lose market share once their patents expire and generic versions are introduced.

Case Studies and Analogies

To understand the potential financial trajectory of CLINORIL, we can look at similar cases:

• Generic Entry and Price Decline: When generic versions of a drug enter the market, the price of the branded drug typically drops significantly. For example, generic drug prices fall with the number of competitors, approaching long-run marginal costs when there are 8 or more competitors[4].
• Pharmaceutical Company Financials: Companies like Medincell, which are involved in developing and marketing pharmaceuticals, often see significant fluctuations in revenue and operating profit based on the lifecycle of their drugs and market competition. For instance, Medincell anticipates a 2- to 3-fold increase in revenue and significant improvement in operating profit due to new partnerships and product launches[5].

Regulatory and Competitive Environment

The regulatory environment and competitive landscape are crucial in determining the financial trajectory of CLINORIL.

• Regulatory Approvals: The approval process for generic versions of CLINORIL can impact its market share. Faster approvals for generics can accelerate the decline in revenue for the branded version.
• Competitive Landscape: The entry of new NSAIDs, both branded and generic, can further erode CLINORIL's market share. The competitive landscape is dynamic, with companies continuously developing new therapies and formulations to capture market share[3].

Key Takeaways

• Clinical Efficacy: CLINORIL has demonstrated significant clinical efficacy in treating various inflammatory conditions.
• Market Trends: The market for traditional NSAIDs like CLINORIL is declining due to generic competition and price reductions.
• Financial Trajectory: The revenue from CLINORIL is expected to decline as generic versions enter the market and prices fall.
• Regulatory and Competitive Environment: The regulatory approval process and competitive landscape play critical roles in determining the financial performance of CLINORIL.

FAQs

What are the primary uses of CLINORIL?

CLINORIL is primarily used to treat osteoarthritis, rheumatoid arthritis, and acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis).

How does CLINORIL compare to other NSAIDs like aspirin?

CLINORIL has been shown to be comparable in effectiveness to high doses of aspirin but with a lower incidence of adverse effects.

What impact does generic competition have on CLINORIL's revenue?

Generic competition significantly reduces the revenue from CLINORIL as prices fall and market share declines.

How do PBMs influence the market for CLINORIL?

PBMs manage drug spend and often report declines in spending on traditional drugs like CLINORIL due to increased generic dispensing rates and unit cost decreases.

What are the key factors affecting the financial trajectory of CLINORIL?

The key factors include generic competition, regulatory approvals, market trends favoring specialty drugs, and the competitive landscape within the NSAID market.

Sources

1. CLINORIL® - accessdata.fda.gov
2. Financial Summary - Clinuvel Pharmaceuticals
3. A Look at PBM Drug Spending: Trend Fueled by Specialty Drug Growth - Clarivate
4. Generic Drug Industry Dynamics - Federal Trade Commission
5. Medincell Publishes Its Consolidated Half-year Financial Results - Business Wire