DICLOFENAC - Generic Drug Details

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

Diclofenac is the generic ingredient in sixteen branded drugs marketed by Zyla, Ibsa, Ibsa Inst Bio, Aurobindo Pharma Ltd, Bionpharma, Onesource Specialty, Asio Holdings, Alkem Labs Ltd, Annora Pharma, Ph Health, Taro, Torrent, Umedica, Amici Pharma, Novartis, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon Research, Senores Pharms, Sun Pharm Industries, Teva, Watson Labs Teva, 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, Sandoz, Sciegen Pharms Inc, 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, Micro Labs, Pliva, Roxane, Teva Pharms, Unique, Dexcel Ltd, Vpna, Pfizer, Actavis Labs Fl Inc, Exela Holdings, Yung Shin Pharm, and Zydus Pharms, and is included in ninety-nine NDAs. There are thirty-nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Diclofenac has forty-four patent family members in twenty-three countries.

There are forty-seven drug master file entries for diclofenac. There are four tentative approvals for this compound.

Summary for DICLOFENAC

International Patents:	44
US Patents:	39
Tradenames:	16
Applicants:	70
NDAs:	99
Drug Master File Entries:	47
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	488
Drug Prices:	Drug price trends for DICLOFENAC
Drug Sales Revenues:	Drug sales revenues for DICLOFENAC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DICLOFENAC
What excipients (inactive ingredients) are in DICLOFENAC?	DICLOFENAC excipients list
DailyMed Link:	DICLOFENAC at DailyMed

See drug prices for DICLOFENAC

See drug sales revenues for DICLOFENAC

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DICLOFENAC

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DICLOFENAC

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

Sponsor	Phase
University of Oklahoma	PHASE4
British University In Egypt	PHASE2
Phenikaa University	PHASE3

See all DICLOFENAC clinical trials

Generic filers with tentative approvals for DICLOFENAC

Applicant	Application No.	Strength	Dosage Form
		1.5% W/W	SOLUTION;TOPICAL
		2%	SOLUTION;TOPICAL
		35MG	CAPSULE;ORAL

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

Medical Subject Heading (MeSH) Categories for DICLOFENAC

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DICLOFENAC

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZORVOLEX	Capsules	diclofenac	18 mg and 35 mg	204592	1	2014-06-06

US Patents and Regulatory Information for DICLOFENAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Labs Fl Inc	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	201089-002	Jul 9, 2012	AB	RX	No	No
Asio Holdings	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes
Yung Shin Pharm	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	205143-001	Feb 19, 2020	AB	RX	No	No
Onesource Specialty	DICLOFENAC POTASSIUM	diclofenac potassium	CAPSULE;ORAL	210078-001	Dec 3, 2019	AB	RX	No	No
Rubicon Research	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075229-002	Sep 16, 2021	AB	RX	No	No

International Patents for DICLOFENAC

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3290030	FORMULATION DE DICLOFÉNAC (DICLOFENAC FORMULATION)
Philippines	12015500301	A NOVEL FORMULATION OF DICLOFENAC
Mexico	347290	UNA FORMULACION NOVEDOSA DE DICLOFENACO. (A NOVEL FORMULATION OF DICLOFENAC.)
European Patent Office	2421525	FORMULATION DE DICLOFÉNAC (DICLOFENAC FORMULATION)
South Korea	101580656

Market Dynamics and Financial Trajectory for Diclofenac

Last updated: November 7, 2025

Introduction

Diclofenac, a non-steroidal anti-inflammatory drug (NSAID), has been a cornerstone in pain management and anti-inflammatory therapy since its FDA approval in 1988. Originally developed by Jansen Pharmaceuticals (a subsidiary of Novartis), diclofenac's widespread application spans multiple indications, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute musculoskeletal injuries. Its predictable efficacy and availability in various formulations (oral, topical, injectable) have cemented its role in global pharmacotherapy.

Understanding the evolving market dynamics and financial trajectory of diclofenac involves analyzing patent statuses, regulatory landscapes, generic competition, regional factors, manufacturing trends, and emerging alternatives. This comprehensive review aims to provide stakeholders with actionable insights into the drug's current market position and future outlook.

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Regulatory and Patent Landscape

Patent Expiry and Generic Competition

Diclofenac's primary patents expired globally by the mid-2000s, which precipitated a market filled with generic manufacturers. As a result, pricing pressures intensified, leading to significantly reduced costs and widespread market accessibility. This patent expiry catalyzed a sharp decline in branded sales but bolstered volume-based growth with affordable options across developing and developed countries.

Regulation and Formulation Approvals

Regulatory agencies worldwide have continuously approved new formulations and indications. Notably, topical diclofenac gels (e.g., Voltaren Gel) gained approval for osteoarthritis of the knee, expanding its use and improving patient compliance. Nevertheless, regulatory barriers and safety concerns—particularly cardiovascular and gastrointestinal risks associated with NSAIDs—prompt ongoing review and, in some cases, withdrawal or restriction of specific formulations or use in vulnerable populations.

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Market Dynamics

Global Market Overview

The global diclofenac market was valued at approximately USD 1.8 billion in 2021, with projections reaching USD 2.3 billion by 2027, reflecting a compound annual growth rate (CAGR) of roughly 4%. The growth trajectory remains modest owing to mature market saturation in many regions and the impact of competing therapies.

Regional Variations

• North America: The analgesic market in North America, including diclofenac, faces stiff competition from novel NSAIDs and COX-2 inhibitors such as celecoxib. Additionally, increased awareness about NSAID-related cardiovascular risks has led to cautious prescribing practices.

• Europe: The European market exhibits steady demand, driven by aging populations and the high prevalence of osteoarthritis and rheumatoid arthritis. Diclofenac remains a first-line OTC/OTC-like option in many countries, although regulatory measures have aimed to limit over-the-counter availability due to safety concerns.

• Asia-Pacific: Emerging markets in Asia-Pacific demonstrate the strongest growth potential. The increasing prevalence of musculoskeletal conditions, growth in healthcare infrastructure, and affordability of generics contribute to expanding demand.

Impact of Safety Profiles

Recent safety concerns, particularly the cardiovascular risk highlighted by FDA warnings and the European Society of Cardiology guidelines, have shifted prescribing patterns. Although these concerns do not eliminate diclofenac usage, they influence clinician choices, especially for high-risk patients, and encourage substitution with safer alternatives.

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Competitive Landscape

Generic Manufacturers

The departure of patent protections has diversified the market, with numerous manufacturers offering low-cost formulations. Key players include Teva, Sandoz, Mylan, and local generics producers. Their competitive pricing has exerted downward pressure on overall market prices and margins.

Innovative Formulations and New Indications

Developments such as diclofenac topical patches and delivery systems aim to improve patient compliance and safety profiles. These innovations typically carry premium pricing and can temporarily bolster the market for specific formulations. However, uptake remains gradual, constrained by regulatory approval timelines and clinical evidence requirements.

Emerging Alternatives

Emerging therapies—including biologic agents for rheumatoid arthritis, novel analgesics, and NSAID replacements—pose competitive threats to diclofenac’s traditional markets. The growing emphasis on personalized medicine and safety profiles favors drugs with targeted mechanisms and fewer systemic effects.

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Financial Trajectory

Revenue Trends

Branded diclofenac revenues have declined markedly post-patent expiry, with the bulk of the market now driven by generics. While individual brand revenues like Voltaren have seen declines, overall market volume remains resilient, especially in emerging markets.

Profitability and Market Margins

Manufacturers benefit from high-volume, low-cost production of generics. Profit margins are under pressure due to intense competition and pricing regulations. However, specialized formulations or higher-margin markets (e.g., topical gels with patented delivery systems) offer opportunities for differential pricing.

Future Revenue Drivers

• Expansion in Emerging Markets: Increasing acceptance and affordability of generics.
• Product Innovation: Improved delivery systems and formulations; combination therapies targeting specific indications.
• Regulatory Approvals: New indications or formulations can yield niche markets and premium pricing.

Risks and Challenges

• Safety and regulatory constraints may limit use in certain populations, reducing market size.
• Competition from newer NSAIDs, COX-2 inhibitors, and non-NSAID analgesics may erode market share.
• Market saturation in mature regions diminishes growth potential.

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Market Outlook

The outlook for diclofenac remains cautiously optimistic, primarily driven by regional demand, product innovation, and a large existing user base. While patent expirations and safety concerns impose constraints, the drug's affordability and efficacy sustain its relevance, especially in cost-sensitive markets.

Growth opportunities hinge upon developing novel formulations that address safety profiles, expanding into underserved regions, and navigating regulatory landscapes to extend indications. Moreover, the trend toward personalized pain management and safer NSAID alternatives may limit long-term growth but could also spur innovation in formulation and delivery.

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Key Takeaways

• Patent expirations have led to a proliferation of generic diclofenac, intensifying market competition and reducing prices.
• Market growth remains modest (~4% CAGR), with higher growth potential in emerging economies driven by increasing prevalence of musculoskeletal disorders.
• Safety concerns, notably cardiovascular risks, influence prescribing patterns, prompting shifts toward safer alternatives in high-risk populations.
• Innovative formulations and new indications offer opportunities for premium pricing, though adoption rates remain gradual.
• Emerging therapies and patient preference for safer options pose long-term challenges to diclofenac’s market dominance.

Strategic Focus: Stakeholders should monitor regulatory trends, prioritize formulation innovation, and target expanding markets in Asia-Pacific. Collaborations on safety and efficacy research could foster regulatory approvals and market acceptance for newer, safer formulations.

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FAQs

1. What are the primary indications for diclofenac?
Diclofenac is mainly prescribed for pain relief and anti-inflammatory treatment in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute musculoskeletal injuries.

2. How has patent expiration affected diclofenac’s market?
Patent expiration transitioned diclofenac from a branded-only product to a widely available generic, significantly lowering prices, increasing accessibility, and intensifying competition.

3. What safety concerns impact diclofenac’s use?
Cardiovascular risks, gastrointestinal bleeding, and renal impairment are notable safety issues. Regulatory agencies recommend cautious prescribing, especially for high-risk patients.

4. Are there innovative formulations of diclofenac?
Yes. Topical gels, patches, and injectable formulations aim to improve safety, targeted delivery, and patient compliance. Some are protected by patents, commanding higher prices.

5. What is the future outlook for diclofenac’s market?
While growth may slow globally, expansion in emerging markets and innovation in formulations offer continued opportunities. Safety concerns and competition from newer therapies remain key challenges.

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References

[1] Statista, “Global NSAID Market Size & Share,” 2022.
[2] MarketWatch, “Diclofenac Market Analysis & Forecast,” 2021.
[3] European Medicines Agency, “Safety of NSAIDs,” 2022.
[4] FDA Drug Safety Communications, “Risks of NSAIDs in Cardiovascular Disease,” 2019.
[5] Research and Markets, “Global Diclofenac Market Trends,” 2022.