DICLOFENAC SODIUM; MISOPROSTOL - Generic Drug Details

What are the generic sources for diclofenac sodium; misoprostol and what is the scope of freedom to operate?

Diclofenac sodium; misoprostol is the generic ingredient in two branded drugs marketed by Pfizer, Actavis Labs Fl Inc, Amneal Pharms, Exela Holdings, Micro Labs, Sandoz, Yung Shin Pharm, and Zydus Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Twelve suppliers are listed for this compound.

Summary for DICLOFENAC SODIUM; MISOPROSTOL

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	12
DailyMed Link:	DICLOFENAC SODIUM; MISOPROSTOL at DailyMed

Pharmacology for DICLOFENAC SODIUM; MISOPROSTOL

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

Anatomical Therapeutic Chemical (ATC) Classes for DICLOFENAC SODIUM; MISOPROSTOL

A02BB	Prostaglandins
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

G02AD	Prostaglandins
G02A	UTEROTONICS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for DICLOFENAC SODIUM; MISOPROSTOL

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 DICLOFENAC SODIUM; MISOPROSTOL

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
Micro Labs	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	204355-002	Jul 15, 2021	AB	RX	No	No
Yung Shin Pharm	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	205143-001	Feb 19, 2020	AB	RX	No	No
Zydus Pharms	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	206771-001	Jun 12, 2023		DISCN	No	No
Exela Holdings	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	200540-001	Mar 14, 2014		DISCN	No	No

Expired US Patents for DICLOFENAC SODIUM; MISOPROSTOL

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

Market Dynamics and Financial Trajectory for Diclofenac Sodium and Misoprostol

Last updated: July 28, 2025

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Introduction

The pharmaceutical landscape for anti-inflammatory and gastrointestinal therapeutics continues to evolve, driven by regional regulations, medical guidelines, patent statuses, and emerging clinical data. Diclofenac Sodium, a non-steroidal anti-inflammatory drug (NSAID), and Misoprostol, a prostaglandin analog, are often co-formulated for specific gastrointestinal indications, notably in preventing NSAID-induced gastric ulcers. Analyzing their market dynamics and fiscal trajectory provides insights valuable for investors, manufacturers, and healthcare policymakers.

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Market Overview

Diclofenac Sodium remains among the most prescribed NSAIDs globally, owing to its efficacy in managing pain and inflammation associated with musculoskeletal conditions, rheumatoid arthritis, and osteoarthritis. The compound's widespread use has been historically supported by a broad patent portfolio. However, patent expirations and the advent of biosimilars and generics have contributed to significant price erosion and increased market competition, especially in the U.S. and European markets.

Misoprostol's primary role lies in gastrointestinal protection and obstetrics. Its utility as a mucosal protectant against NSAID-induced ulcers has sustained demand, particularly amid global efforts to broaden NSAID use with safer profiles. Regulatory shifts, notably approvals for its use in labor induction and abortion protocols, expand its market scope. Yet, regulatory scrutiny and safety concerns regarding side effects temper growth projections, especially in conservative markets.

Co-formulation Trends: The combination of Diclofenac and Misoprostol, branded as Arthrotec in certain markets, exemplifies strategic innovation. This formulation aims to mitigate gastrointestinal adverse effects of NSAIDs, positioning it as a premium therapeutic option. The clinical validation of such combinations influences market adoption, particularly among high-risk patient groups.

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Market Drivers

• Growing Prevalence of Chronic Pain and Arthritis: An aging global population fuels demand for NSAIDs. The WHO reports over 350 million cases of osteoarthritis worldwide, bolstering the demand for Diclofenac-based therapies [1].

• Increased Awareness of NSAID-Induced Gastrointestinal Risks: Elevated prescription of gastroprotective agents like Misoprostol in conjunction with NSAIDs reflects a proactive approach to adverse event mitigation, expanding the combined therapy market.

• Regulatory Expansions and Approvals: Clearer labeling, safety updates, and approval for new indications influence physician prescribing behaviors favorably.

• Pharmacoeconomic Shifts: Cost-effective generics reduce barriers to access, though brand-name co-formulations maintain premium pricing segments.

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Market Challenges

• Safety and Side Effect Profiles: NSAIDs pose cardiovascular risks, while Misoprostol’s gastrointestinal side effects limit its tolerability, constraining utilization in some patient populations [2].

• Regulatory and Legal Hurdles: Stringent oversight, particularly regarding Misoprostol’s use in reproductive health, influences market access in specific regions.

• Generic Competition: Patent expirations catalyze price reductions. Diclofenac's patent expiry in many regions has increased generic penetration, pressuring branded sales.

• Market Saturation and Off-Label Use: Overprescription of NSAIDs, coupled with off-label practices, introduces regulatory challenges and risks of adverse events, influencing clinical guidelines.

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Financial Trajectory

Revenue Trends: The global NSAID market was valued at approximately $6 billion in 2020, with Diclofenac contributing a substantial share. Forecasts project a compound annual growth rate (CAGR) of 2-4% through 2028, driven by aging demographics and expanded indications [3].

Impact of Patent Expiries: The decline in Diclofenac branded products is offset somewhat by robust sales of generic versions, maintaining overall revenue streams. For co-formulations like Arthrotec, limited formulary penetration and patent exclusivities sustain higher profit margins initially.

Geographic Variances: Developed markets like North America and Europe exhibit stable growth, constrained by regulatory scrutiny. Emerging markets, notably Asia-Pacific, demonstrate faster growth driven by increasing healthcare access and local manufacturing capacities.

Investment and R&D: Companies investing in reformulations, such as extended-release formulations or novel delivery mechanisms, aim to capture niche markets. Venture capital and pharmaceutical R&D continue seeking safer NSAID alternatives, indirectly impacting Diclofenac’s market share.

Role of Reimbursement Policies: In markets with comprehensive insurance coverage, co-formulations are more accessible, positively influencing sales. Conversely, lack of reimbursement dampens growth prospects.

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Future Outlook

The convergence of clinical advancements, regulatory conformity, and strategic marketing will shape the financial trajectory. The market is expected to experience moderate growth, with shifts toward personalized medicine where NSAID formulations are tailored to patient-specific risks.

Innovations in drug delivery—such as transdermal patches and controlled-release formulations—offer potential to extend product life cycles. The ongoing debate surrounding NSAID safety underscores the importance of alternative analgesic development, which could influence Diclofenac’s market dominance.

In terms of regional expansion, Asia-Pacific, Latin America, and parts of Africa present opportunistic growth vectors due to increasing healthcare infrastructure and rising disease burden.

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Key Takeaways

• The Diclofenac sodium and Misoprostol market is characterized by mature product lines facing pricing pressures from generics, yet sustained demand via combination formulations.

• Demographic shifts and rising chronic disease prevalence underpin continuous demand, particularly in emerging markets.

• Safety concerns serve as both a market challenge and an avenue for pharmaceutical innovation, fostering development of safer NSAID alternatives.

• Reimbursement policies, regional regulations, and ongoing clinical validations significantly influence revenue prospects.

• Strategic investments into formulations, combination therapies, and alternative delivery mechanisms are essential for maintaining market relevance.

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FAQs

1. How do patent expirations impact the marketability of Diclofenac Sodium?
Patent expirations lead to increased generic competition, driving down prices and eroding branded product revenue. Companies mitigate this by developing new formulations, combination products, or expanding indications to sustain profitability.

2. What factors influence the adoption of Diclofenac and Misoprostol co-formulations?
Safety profiles, clinical guidelines, regulatory approvals, and reimbursement policies influence adoption. Physician familiarity and patient tolerability also play critical roles.

3. Are there notable regional differences in market growth?
Yes. Developed regions face saturation and regulatory restrictions, limiting growth. Emerging markets exhibit rapid expansion due to unmet needs, increased healthcare access, and local manufacturing.

4. What are the primary risks associated with these drugs?
NSAIDs like Diclofenac pose cardiovascular and gastrointestinal risks; Misoprostol can cause diarrhea and uterine contractions. These safety concerns affect prescribing patterns and regulatory status.

5. How might future innovations influence the market?
Advances in drug delivery, personalized medicine, and the development of NSAID replacements can reshape demand, offering safer, more targeted therapy options.

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Citations

[1] World Health Organization. Osteoarthritis Fact Sheet. 2022.
[2] Lanza FL, et al. "Appropriate use of NSAIDs and gastroprotection." Gastroenterology, 2007.
[3] MarketWatch. "NSAID Market Forecast to 2028." 2021.