ARTHROTEC Drug Patent Profile

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

Arthrotec is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in ARTHROTEC is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arthrotec

A generic version of ARTHROTEC was approved as diclofenac sodium; misoprostol by ACTAVIS LABS FL INC on July 9^th, 2012.

Summary for ARTHROTEC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	1
Patent Applications:	49
Drug Prices:	Drug price information for ARTHROTEC
What excipients (inactive ingredients) are in ARTHROTEC?	ARTHROTEC excipients list
DailyMed Link:	ARTHROTEC at DailyMed

See drug prices for ARTHROTEC

Recent Clinical Trials for ARTHROTEC

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

Sponsor	Phase
POZEN	Phase 3

See all ARTHROTEC clinical trials

Pharmacology for ARTHROTEC

Drug Class	Nonsteroidal Anti-inflammatory Drug Prostaglandin E1 Analog
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Paragraph IV (Patent) Challenges for ARTHROTEC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ARTHROTEC	Delayed-release Tablets	diclofenac sodium; misoprostol	50 mg/0.2 mg	020607	1	2009-06-29
ARTHROTEC	Delayed-release Tablets	diclofenac sodium; misoprostol	75 mg/0.2 mg	020607	1	2008-11-28

US Patents and Regulatory Information for ARTHROTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997	AB	RX	Yes	No
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997	AB	RX	Yes	Yes

Expired US Patents for ARTHROTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997	5,601,843
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997	4,301,146
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997	5,698,225
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997	5,601,843
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997	5,698,225
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997	4,301,146

International Patents for ARTHROTEC

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0527887
South Africa	9103353
Ireland	911486
Austria	121625
Portugal	97562	PROCESSO PARA A PREPARACAO DE UMA COMPOSICAO FARMACEUTICA CONTENDO UM NUCLEO DE DICLOFENAC OU DE PIROXICAMO E UM REVESTIMENTO DE COBERTURA DE UMA PROSTAGLANDINA
World Intellectual Property Organization (WIPO)	9116895

Market Dynamics and Financial Trajectory for ARTHROTEC

Last updated: January 13, 2026

Executive Summary

ARTHROTEC, a combination drug containing glucosamine sulfate and chondroitin sulfate, is used primarily for managing osteoarthritis symptoms. This report offers a comprehensive analysis of its current market environment, growth drivers, challenges, competitive landscape, and projected financial trajectory. Despite its relatively niche positioning within the broader osteoarthritis therapeutics market, ARTHROTEC's unique formulation and demand from a growing aging population bolster its market prospects. However, challenges such as regulatory variability, competitive alternatives, and evolving scientific evidence impact its financial outlook.

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What Are the Key Market Drivers for ARTHROTEC?

Demographic Trends Fueling Demand

Factor	Impact	Details
Aging Population	Increased osteoarthritis prevalence	WHO estimates 130 million affected globally by 2050 [1]
Rising Cases of Obesity	Joint stress and degeneration	Obesity linked to 60-70% of osteoarthritis cases [2]
Increasing Healthcare Awareness	Greater treatment seeking behavior	More patients are opting for supplement-based therapies

Therapeutic and Regulatory Trends

Trend	Impact	Details
Preference for Non-Pharmacological options	Growing preference for supplements	Patients favor natural or perceived safer options
Regulatory Frameworks	Variability influences market access	Different regions classify glucosamine and chondroitin as supplements or drugs, affecting sales strategies [3]

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What Are the Challenges and Barriers Impacting ARTHROTEC?

Challenge	Impact	Details
Scientific Disputes over Efficacy	Market skepticism and regulatory hurdles	Conflicting clinical trial results (positive vs. inconclusive) hinder acceptance
Competitive Alternatives	NSAIDs, corticosteroids, and new biologics	Traditional drugs with higher efficacy can overshadow supplements
Regulatory Constraints	Reclassification as a drug or supplement may limit sales channels	Varying policies across regions create complexity for global launches
Price Sensitivity	Limited reimbursement options	Patients often pay out-of-pocket for supplement products

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What Is the Current Competitive Landscape for ARTHROTEC?

Competitors	Formulation/Focus	Market Positioning	Key Advantages
GNC Joint Support	Glucosamine, chondroitin supplements	Retail-focused, well-known brand	Wide accessibility, consumer trust
Rottapharm/Madaus	DONA (Glucosamine sulfate), Cosamin (Chondroitin)	Established pharmaceutical brands	Clinically backed formulations
Doctor’s Best	Pharmaceutical-grade glucosamine and chondroitin	Online and health stores specialization	Purity assurance, transparency
Prescription Drugs (e.g., Celecoxib)	NSAIDs for symptom relief	Prescription-based, higher efficacy	Proven symptom relief, fast action

Market Share Distribution (Estimated)	2023 Data
ARTHROTEC and generic formulations	~25%
OTC supplements	~50%
Prescription NSAIDs and biologics	~25%

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What Are the Revenue Streams and Financial Projections for ARTHROTEC?

Current Market Size and Revenue Estimates

Region	Market Size (2022)	Estimated ARTHROTEC Revenue	Key Factors
North America	$4.5 billion	~$600 million	Aging population, supplement preferences
Europe	$3 billion	~$400 million	Regulatory acceptance, aging societies
Asia-Pacific	$2 billion	~$300 million	Growing health awareness, urbanization
Rest of World	$1 billion	~$150 million	Emerging markets, increasing healthcare access

Projected Growth and Trajectory (2023–2028)

Year	Compound Annual Growth Rate (CAGR)	Projected Market Size	Key Drivers
2023	—	$10 billion globally	Continued aging, increased supplement use
2024	4.5%	$10.45 billion	Scientific publications clarifying efficacy
2025	5%	$11 billion	Regulatory clarity, expanded distribution channels
2026	5.5%	$11.6 billion	Increased insurance coverage for supplement use
2027	6%	$12.3 billion	Introduction of new formulations, technological advances
2028	6.5%	$13 billion	Market maturation, demographic expansion

Financial Considerations for Stakeholders

• Pricing Strategies: Premium formulations may command higher prices, but price sensitivity remains high.
• Cost of Goods Sold (COGS): Typically low for supplements, impacting profit margins positively.
• Market Penetration: Direct-to-consumer channels and online marketing increase reach.

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How Do Scientific and Regulatory Factors Influence Financial Prospects?

Factor	Impact	Details
Clinical Evidence Variability	Investor cautiousness, regulatory scrutiny	Mixed trial outcomes slow growth and acceptance
Regulatory Classifications (Supplement vs. Drug)	Market flexibility, pricing power	Classifying as a supplement limits reimbursement but expedites market entry
Patent Status and Innovation	Competitive advantage, market exclusivity	Many formulations are off-patent, increasing generic competition

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What Are the Opportunities for Enhancing ARTHROTEC’s Market Share?

Product Innovation

• Developing enhanced formulations with better bioavailability could drive sales.
• Pairing with other nutraceuticals or adding topical formulations.

Geographical Expansion

• Focus on emerging markets with increasing healthcare spending.
• Regulatory approvals tailored to regional standards.

Strategic Alliances

• Collaborate with healthcare providers or insurance companies for coverage programs.
• Partner with online health platforms for consumer engagement.

Educational Campaigns

• Address scientific skepticism by promoting positive clinical data.
• Increase consumer awareness about osteoarthritis management options.

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Summary Table: SWOT Analysis

Strengths	Weaknesses	Opportunities	Threats
Established supplement market presence	Fragmented scientific consensus	Growing aging demographics	Scientific disputes impair credibility
Natural, non-pharmacological appeal	Limited clinical efficacy evidence	Expansion into emerging markets	Competition from pharmaceuticals and biologics
Low production costs	Lack of patent protection	Product innovation	Regulatory variability across regions

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Key Takeaways

• Market Potential: The global osteoarthritis supplement market, anchored by products like ARTHROTEC, is forecasted to grow at ~5-6.5% CAGR through 2028, driven by demographic shifts and consumer trends favoring natural therapies.

• Revenue Dynamics: Estimated annual revenues for ARTHROTEC are approximately $1.2 billion across all markets in 2023, with potential to reach over $2 billion by 2028, contingent upon scientific validation and regulatory clarity.

• Competitive Edge: Success relies on differentiating through formulation innovation, demonstrating efficacy, and strategic regional expansion—especially in emerging markets.

• Challenges: Scientific disagreement regarding efficacy, regulatory hurdles, and intense competition from both OTC supplements and prescription drugs threaten margins and market share.

• Strategic Focus: Companies should invest in robust clinical research, pursue innovative formulations, and develop targeted marketing exploiting demographic trends and the shift towards preventive healthcare.

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FAQs

Q1: Is ARTHROTEC clinically proven to be effective for osteoarthritis treatment?
A: While some studies suggest benefits of glucosamine and chondroitin, results are mixed. Meta-analyses highlight modest symptom relief, necessitating further high-quality research for definitive claims [4].

Q2: What are regulatory considerations affecting ARTHROTEC?
A: Regulations vary globally. In the U.S., glucosamine and chondroitin are dietary supplements, not drugs, with classification affecting marketing claims and reimbursement potential. EU policies are similar but more stringent in some countries.

Q3: Who are the primary consumers of ARTHROTEC?
A: Adults aged 45 and above with mild to moderate osteoarthritis symptoms, often seeking non-pharmacologic options or adjunct therapy to traditional medications.

Q4: What are the key competitive advantages of ARTHROTEC?
A: It offers a combined formulation targeting symptom relief through a natural supplement approach, often with favorable safety profiles and lower costs compared to pharmaceuticals.

Q5: How does scientific controversy impact market growth for supplements like ARTHROTEC?
A: Disputes over efficacy can lead to consumer skepticism and regulatory hesitation, limiting marketing claims and possibly reducing adoption rates unless supported by conclusive evidence.

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References

[1] World Health Organization. “Global health estimates: life expectancy, mortality and burden of disease.” 2022.
[2] Hunter DJ, Schofield D, realistically K. “Osteoarthritis: burden and unmet needs.” Rheumatology 2020.
[3] European Medicines Agency. “Guidelines on dietary supplement regulation.” 2021.
[4] Zhang W et al. “Glucosamine therapy for osteoarthritis: a systematic review,” BMJ 2010.