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	020607-001	Dec 24, 1997
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997

International Patents for ARTHROTEC

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

Country	Patent Number	Title	Estimated Expiration
South Africa	9103353
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
Austria	121625
Spain	2071312
Ireland	911486
World Intellectual Property Organization (WIPO)	9116895
Denmark	0527887

Market Dynamics and Financial Trajectory for ARTHROTEC: An In-Depth Analysis

Last updated: July 29, 2025

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Introduction

ARTHROTEC is a pharmaceutical combination drug primarily used for the management of osteoarthritis-associated pain. It contains two active ingredients: Diclofenac, a non-steroidal anti-inflammatory drug (NSAID), and Misoprostol, a prostaglandin analog that amplifies the gastrointestinal safety profile of NSAIDs. As a complex formulation targeting a prevalent condition, ARTHROTEC's market dynamics are influenced by a multifaceted interplay of clinical efficacy, regulatory landscapes, demographic trends, and competitive pressures. This analysis explores these factors and projects the drug’s financial trajectory within a competitive pharmaceutical environment.

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Market Landscape

Global Osteoarthritis Prevalence and Market Size

Osteoarthritis (OA) affects over 300 million people worldwide, making it one of the most common degenerative joint diseases [[1]]. The global OA therapeutics market was valued at approximately USD 4.4 billion in 2020 and is projected to reach USD 6.3 billion by 2026, growing at a CAGR of around 6.3% [[2]]. The escalated prevalence, especially among aging populations, supports sustained demand for symptom management drugs like ARTHROTEC.

Key Healthcare Drivers

• Aging Population: The global demographic shift toward older populations significantly inflates OA incidence, notably in North America, Europe, and Asia-Pacific regions [[3]].
• Rising Obesity Rates: Excess weight contributes to joint stress, amplifying the OA burden [[4]].
• Advances in Pain Management: Increasing preference for combination therapies that balance efficacy with safety enhances ARTHROTEC’s market potential.

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Regulatory and Clinical Considerations

Regulatory Status and Approval Pathways

ARTHROTEC’s components—Diclofenac and Misoprostol—are individually approved in various regions, with approved indications primarily for pain management. However, combining these drugs under a proprietary label requires regulatory clearance, emphasizing safety profiling, especially concerning gastrointestinal and reproductive side effects [[5]]. Regulatory authorities like the FDA and EMA demand extensive clinical data to support combination safety and efficacy, particularly in populations vulnerable to NSAID-related adverse effects.

Clinical Efficacy and Safety Profile

The combination’s rationale is to mitigate NSAID-induced gastrointestinal toxicity via Misoprostol co-administration. Clinical trials demonstrate that ARTHROTEC effectively reduces OA pain while decreasing gastrointestinal adverse events compared to NSAIDs alone [[6]]. Nevertheless, Misoprostol’s side effects—such as diarrhea and abdominal cramping—may limit tolerability, impacting market acceptance.

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Competitive Landscape

ARTHROTEC faces competition from multiple fronts:

• NSAID Monotherapies: Generic diclofenac, ibuprofen, and naproxen dominate the market, offering cost-effective options.
• Gastroprotective Agents: Proton pump inhibitors (PPIs) like omeprazole are used adjunctively to reduce NSAID-induced GI toxicity.
• Other NSAID-Misoprostol Combinations: Marketed formulations like Arthrotec, which contain similar constituents, provide direct competition.
• Non-Pharmacological Alternatives: Physical therapy, corticosteroid injections, and emerging biologics shift some patient segments from oral NSAIDs.

Market share gains for ARTHROTEC depend significantly on its ability to differentiate through clinical benefits, safety profile, and payer reimbursement strategies.

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Economic and Financial Trajectory

Pricing and Reimbursement Considerations

• Pricing Strategy: Given the availability of generic NSAIDs and over-the-counter options, ARTHROTEC's premium pricing hinges on demonstrated superior safety and efficacy.
• Reimbursement Environment: Insurance coverage and formulary inclusion are critical. Evidence demonstrating cost-effectiveness relative to standard therapies enhances reimbursement prospects.

Market Penetration and Adoption Rate

ARTHROTEC’s adoption depends on prescriber familiarity, patient tolerability, and regulatory endorsement. Market penetration is likely to be incremental, initially targeting patients at higher risk for gastrointestinal complications who require NSAID therapy.

Revenue Projections

Assuming conservative market penetration of 5-10% among OA patients in developed markets within five years, and considering a price point of USD 2-5 per tablet, potential revenues could range from USD 100 million to USD 500 million annually globally. Factors such as patent protections, lifecycle management, and strategic marketing will influence these figures.

Patent and Market Exclusivity

Patent protection and exclusivity rights significantly impact financial outlooks. While ARTHROTEC’s formulation might benefit from patent protections, patent expirations could open avenues for generics, eroding market share and profits.

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Market Challenges and Opportunities

Challenges:

• Generic Competition: The widespread availability of generic NSAIDs limits pricing power.
• Side Effect Profile: Tolerability issues and contraindications restrict use in certain populations.
• Regulatory Hurdles: Stringent safety data requirements could delay approval or restrict indications.

Opportunities:

• Personalized Medicine: Identifying high-risk populations to optimize therapy benefits.
• Combination Therapy Innovations: Potential to combine with other pharmacologics targeting OA or comorbidities.
• Regional Expansion: Emerging markets with rising OA prevalence present growth prospects.

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Conclusion: Future Outlook for ARTHROTEC

ARTHROTEC’s market positioning hinges on its clinical advantage in mitigating NSAID-related gastrointestinal toxicity. Its financial trajectory depends on successful regulatory navigation, strategic pricing, and evolving clinical guidelines favoring combination therapies. As the global OA burden intensifies with demographic shifts, ARTHROTEC stands to benefit from a growing patient base, provided it effectively differentiates itself amid a backdrop of generic competition and safety considerations.

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Key Takeaways

• The global osteoarthritis market is expanding, driven by aging populations and rising obesity, creating favorable demand conditions for drugs like ARTHROTEC.
• Regulatory approval and clinical validation of ARTHROTEC's combination efficacy and safety are pivotal for market penetration.
• Competition from generics and other NSAID formulations constrains pricing power; differentiation based on safety profile is crucial.
• Financial success relies on strategic pricing, reimbursement negotiations, and targeted marketing toward high-risk patient populations.
• Future growth hinges on expanding regional markets, personalized treatment approaches, and potential lifecycle management.

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FAQs

1. What distinguishes ARTHROTEC from other NSAID therapies?
ARTHROTEC combines Diclofenac with Misoprostol, aiming to provide analgesic effects while reducing gastrointestinal side effects common with NSAID monotherapy.

2. What are the primary safety concerns associated with ARTHROTEC?
Potential side effects include gastrointestinal disturbances, diarrhea, and contraindications in pregnant women due to Misoprostol’s abortifacient properties.

3. How does the patent landscape influence ARTHROTEC’s market prospects?
Patent protections provide exclusivity, enabling higher pricing and market share retention. Patent expirations could lead to increased competition from generics, impacting revenues.

4. Which regions offer the most growth potential for ARTHROTEC?
Emerging markets in Asia-Pacific and Latin America present expanding patient populations and healthcare infrastructure for OA management.

5. What strategic measures could enhance ARTHROTEC’s market adoption?
Focused clinical education, reimbursement negotiations, and positioning in guidelines emphasizing combination therapy benefits will strengthen its market presence.

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References

[1] World Health Organization. (2020). Osteoarthritis Fact Sheet.
[2] MarketsandMarkets. (2021). Osteoarthritis Therapeutics Market Report.
[3] Cooper C, et al. (2010). The Global Burden of Osteoarthritis: A Systematic Review. Osteoarthritis Cartilage.
[4] Sun Y, et al. (2018). Obesity and Osteoarthritis: The Link and Potential Interventions. J Orthop Res.
[5] U.S. Food and Drug Administration. (2022). Regulatory Requirements for Combination Drugs.
[6] Rodriguez-Merchan EC. (2020). Osteoarthritis management strategies. Clin Rheumatol.