Diclofenac sodium - Generic Drug Details

What are the generic drug sources for diclofenac sodium and what is the scope of patent protection?

Diclofenac sodium is the generic ingredient in nine branded drugs marketed by Actavis Mid Atlantic, Alembic, Amneal, Amneal Pharms, Aurolife Pharma Llc, Cipla, Encube, Glenmark Pharms Ltd, Hikma, Padagis Israel, Perrigo Pharma Intl, Sun Pharma Canada, Fougera Pharms, Haleon Us Holdings, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon Research, Sandoz, Sciegen Pharms Inc, Novartis, Javelin Pharms Inc, Apotex, Epic Pharma Llc, Lupin Ltd, Lupin Pharms, Novel Labs Inc, Pai Holdings Pharm, Twi Pharms, Watson Labs Inc, Zydus Lifesciences, Horizon, Nuvo Pharms Inc, Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Chartwell Rx, Micro Labs, Pliva, Roxane, Teva, Teva Pharms, Umedica, Unique, Dexcel Ltd, Novast Labs, Vpna, Pfizer, Actavis Labs Fl Inc, Exela Holdings, Yung Shin Pharm, and Zydus Pharms, and is included in seventy-four NDAs. There are twenty patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diclofenac sodium has forty-two patent family members in fifteen countries.

There are twenty-one drug master file entries for diclofenac sodium. One hundred and twenty-eight suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for diclofenac sodium

International Patents:	42
US Patents:	20
Tradenames:	9
Applicants:	53
NDAs:	74
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	128
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	161
Patent Applications:	6,907
Drug Prices:	Drug price trends for diclofenac sodium
Drug Sales Revenues:	Drug sales revenues for diclofenac sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for diclofenac sodium
What excipients (inactive ingredients) are in diclofenac sodium?	diclofenac sodium excipients list
DailyMed Link:	diclofenac sodium at DailyMed

See drug prices for diclofenac sodium

See drug sales revenues for diclofenac sodium

Recent Clinical Trials for diclofenac sodium

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

Sponsor	Phase
British University In Egypt	PHASE2
Mariam Hesham Mahmoud Abdelfattah Eissa	NA
Sohag University	NA

See all diclofenac sodium clinical trials

Generic filers with tentative approvals for DICLOFENAC SODIUM

Applicant	Application No.	Strength	Dosage Form
		1.5% W/W	SOLUTION;TOPICAL
		2%	SOLUTION;TOPICAL
		2%	SOLUTION;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for diclofenac sodium

Drug Class	Nonsteroidal Anti-inflammatory Drug Anti-coagulant Calculi Dissolution Agent
Mechanism of Action	Cyclooxygenase Inhibitors Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Prostaglandin Production Decreased Coagulation Factor Activity

Anatomical Therapeutic Chemical (ATC) Classes for diclofenac sodium

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

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DYLOJECT	Injection	diclofenac sodium	37.5 mg/mL, 1 mL single-dose vials	022396	1	2015-12-15
PENNSAID	Topical Solution	diclofenac sodium	2.0%	204623	1	2014-06-03
PENNSAID	Topical Solution	diclofenac sodium	1.5%	020947	1	2012-07-11
SOLARAZE	Topical Gel	diclofenac sodium	3%	021005	1	2009-12-16

US Patents and Regulatory Information for diclofenac sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No			Y
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No			Y
Yung Shin Pharm	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	205143-002	Feb 19, 2020	AB	RX	No	No
Exela Holdings	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	200540-002	Mar 14, 2014		DISCN	No	No
Amneal Pharms	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	203995-002	Nov 25, 2016	AB	RX	No	No
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000		DISCN	Yes	No

Expired US Patents for diclofenac sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037-001	Mar 28, 1991
Novartis	VOLTAREN	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	019201-002	Jul 28, 1988
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000
Novartis	VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037-001	Mar 28, 1991
Fougera Pharms	SOLARAZE	diclofenac sodium	GEL;TOPICAL	021005-001	Oct 16, 2000
Novartis	VOLTAREN	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	019201-003	Jul 28, 1988

International Patents for diclofenac sodium

Country	Patent Number	Title	Estimated Expiration
Israel	198161	ג'ל דיכלופני (Diclofenac gel)
South Africa	200903135	Diclofenac gel
World Intellectual Property Organization (WIPO)	2007112272
Israel	194185	פורמולציות של דיקלופנאק במינון נמוך וציקלודקסטרין ושימוש בהן לשיכוך כאבים (Formuations of low dose diclofenac and beta-cyclodextrin and use thereof for effecting analgesia)
Brazil	PI0709409
China	104606126	DICLOFENAC GEL

Market Dynamics and Financial Trajectory for Diclofenac Sodium

Last updated: November 14, 2025

Introduction

Diclofenac sodium stands as a cornerstone in the non-steroidal anti-inflammatory drug (NSAID) category, primarily prescribed for pain management, inflammation reduction, and musculoskeletal conditions. Its extensive clinical utility, alongside a competitive landscape influenced by regulatory, patent, and technological shifts, makes understanding its market dynamics critical for stakeholders. This analysis dissects the prevailing factors shaping Diclofenac sodium's market and projects its financial trajectory within global pharmaceutical markets.

Market Overview and Historical Context

Established as one of the most prescribed NSAIDs globally, Diclofenac sodium has remained a mainstay in pain management. Originally introduced in the 1970s, its widespread adoption is bolstered by robust efficacy in conditions such as osteoarthritis, rheumatoid arthritis, and acute musculoskeletal injuries [1]. The compound's core formulations—oral tablets, topical gels, patches, and injectable forms—have diversified its application base.

Historically, the drug enjoyed patent protection differentiating brand formulations from generics—primarily till patent expiration in various jurisdictions around the early 2010s. The consequent proliferation of generics precipitated significant price competition but maintained consumer reliance due to established efficacy and safety profiles.

Current Market Dynamics

Regulatory Factors

Regulatory strides, notably the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), have implemented stringent safety evaluations for NSAIDs, including post-market surveillance of adverse cardiovascular and gastrointestinal risks associated with Diclofenac sodium [2]. These measures influence prescribing behaviors and formulation development, often favoring lower-dose or alternative delivery mechanisms.

Patent and Generic Competition

Patent expirations have spurred intense generic competition, exerting downward pressure on pricing and margins. However, branded formulations continue to dominate in certain regions owing to brand loyalty and perceived safety assurances. Despite this, the generic market's growth enhances accessibility and volume sales but compresses revenue per unit.

Formulation Innovations

Recent technological advances have enabled development of new formulations—hydrogel patches, transdermal systems, and combination medications—aimed at improving efficacy, safety, and patient compliance [3]. These innovations promote market renewal, especially amidst ongoing safety concerns with traditional oral forms.

Market Penetration and Geographic Dynamics

Emerging markets, notably in Asia-Pacific and Latin America, contribute a significant share of sales volume due to increasing healthcare expenditure, rising prevalence of musculoskeletal disorders, and lower generic pricing barriers [4]. Conversely, stringent regulatory landscapes in North America and Europe influence product availability, reimbursement criteria, and prescribing habits.

Competitive Landscape

Apart from generics, key branded players like Novartis with Voltaren and Mylan with Datril maintain market relevance through marketing, quality assurance, and new formulation pipelines. Additionally, the development of biosimilars and combination therapies further diversifies the competitive environment.

Financial Trajectory Analysis

Revenue Trends

Global sales of Diclofenac sodium are projected to witness modest CAGR (Compound Annual Growth Rate) fluctuations over the next five years, influenced heavily by patent landscapes and regulatory influences. According to recent market reports [5], the NSAID market is expected to grow at approximately 4-5% annually, with Diclofenac sodium comprising a substantial portion, especially in OTC segments.

Market Drivers

1. Increasing Prevalence of Chronic Conditions: Osteoarthritis and rheumatoid arthritis prevalence are rising globally, underpinning sustained demand.
2. Enhanced Formulations and Delivery Systems: Innovations leading to improved safety profiles (e.g., reduced gastrointestinal risks) bolster consumption.
3. Emerging Market Expansion: Growth in healthcare infrastructure and affordability drives increased adoption.

Market Challenges

1. Safety Concerns and Regulatory Restrictions: Elevated cardiovascular risk warnings have prompted usage limitations and shifted prescribing patterns.
2. Competition from Other NSAIDs and COX-2 Selective Inhibitors: Drugs like celecoxib offer similar efficacy with potentially better safety profiles but face their own market challenges.
3. Pricing Pressure: High generic penetration depresses gross margins, requiring strategic focus on differentiation through formulation or branding.

Forecasted Financial Outlook

While exact revenue figures vary regionally, industry consensus forecasts that Diclofenac sodium's global market value will stabilize or decline marginally in developed regions due to safety concerns and market saturation. Conversely, emerging markets are expected to see accelerated growth, offsetting declines elsewhere. A compound annual growth rate of 2-3% over the next five years is plausible, driven largely by increase in volume sales rather than price.

Strategic Considerations for Stakeholders

• Innovation Pipelines: Prioritize development of formulations with improved safety profiles, such as transdermal patches or nanotechnology-based delivery systems.
• Regulatory Engagement: Proactively adapt to evolving safety guidelines to sustain market access.
• Market Expansion: Leverage opportunities in emerging economies, tailoring formulations to regional preferences and healthcare infrastructure.
• Pricing Strategies: Balance affordability with profitability, especially in highly competitive markets.

Conclusion

Diclofenac sodium’s market is characterized by mature product lines facing safety-related regulatory shifts, intense generic competition, and opportunities in formulation innovations. Its financial trajectory hinges on strategic adaptation—embracing technological advances, expanding geographically, and aligning with safety standards. While near-term growth may be constrained in developed markets, emerging economies present sustainable growth avenues, ensuring Diclofenac sodium remains a pivotal NSAID in global pain management.

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Key Takeaways

• Market Maturity & Competition: Generic proliferation and patent expiries have tempered revenue growth but expanded global accessibility.
• Safety & Regulatory Impact: Evolving safety profiles and regulations are shaping prescribing behaviors and limiting growth in some regions.
• Innovation as Growth Catalyst: Development of safer, patient-friendly formulations offers avenues for revenue revitalization.
• Emerging Markets Drive Future Growth: Asia-Pacific and Latin America are poised for increased demand due to rising prevalence of relevant conditions and healthcare spending.
• Strategic Focus Areas: Innovation, regulatory compliance, and regional expansion are essential for maintaining competitive advantage.

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FAQs

1. How has patent expiry affected Diclofenac sodium’s market share?
Patent expiries led to a surge in generic competitors, reducing prices and profit margins for branded formulations, but increased overall volume sales and market penetration worldwide.

2. What safety concerns are influencing Diclofenac sodium's usage?
Elevated risks of cardiovascular events and gastrointestinal complications have prompted regulatory warnings, usage restrictions, and a shift toward alternative therapies in some regions.

3. Are there ongoing innovations that could revitalize the Diclofenac sodium market?
Yes. Transdermal patches, topical gels, and nanotechnology-based delivery systems aim to enhance safety, efficacy, and patient adherence, providing competitive differentiation.

4. Which regions offer the most growth potential for Diclofenac sodium?
Emerging markets in Asia-Pacific and Latin America show promising growth due to expanding healthcare infrastructure, increasing disease prevalence, and lower regulatory barriers.

5. What is the future outlook for Diclofenac sodium’s revenues?
While growth may slow in mature markets, overall revenues are expected to stabilize or moderately increase over the next five years, driven primarily by volume increases in emerging economies.

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References

[1] GlobalData. “NSAIDs Market Analysis.” 2022.
[2] EMA. “Safety Review of Diclofenac-containing medicines.” 2021.
[3] Pharmaceutical Technology. “Innovations in NSAID Formulations.” 2022.
[4] IQVIA. “Emerging Markets Pharmaceutical Trends.” 2022.
[5] MarketsandMarkets. “NSAID Market Forecast.” 2023.