DICLOFENAC SODIUM - Generic Drug Details

What are the generic 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, Taro, Fougera Pharms, Haleon Us Holdings, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon, 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, Unique, Dexcel Ltd, Riconpharma Llc, Vpna, Pfizer, Actavis Labs Fl Inc, Exela Holdings, Yung Shin Pharm, and Zydus Pharms, and is included in seventy-two 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-seven 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:	52
NDAs:	72
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	127
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	145
Patent Applications:	7,113
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
Jamia Millia Islamia	N/A
University of Rijeka	N/A
Fayoum University Hospital	N/A

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
Altaire Pharms Inc	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	203383-001	Nov 16, 2015	AT	RX	No	No
Vpna	DICLOFENAC SODIUM	diclofenac sodium	TABLET, EXTENDED RELEASE;ORAL	075492-001	Feb 11, 2000	AB	RX	No	No
Teva Pharms	DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	074459-003	Jun 25, 1997		DISCN	No	No
Carlsbad	DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	075185-002	Nov 13, 1998	AB	RX	No	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

International Patents for DICLOFENAC SODIUM

Country	Patent Number	Title	Estimated Expiration
Israel	198161	ג'ל דיכלופני (Diclofenac gel)
South Korea	20080112285	FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN
Hong Kong	1134024	DICLOFENAC GEL
Brazil	PI0717769	FORMULAÇÃO DE GEL, MÉTODO PARA O TRATAMENTO DA OSTEOARTRITE EM UM INDIVÍDUO SOFRENDO DE DOR ARTICULAR, E, USO DE DICLOFENAC DE SÓDIO

DICLOFENAC SODIUM Market Analysis and Financial Projection Experimental

Diclofenac Sodium Market Dynamics and Financial Trajectory

Market Overview

The diclofenac sodium market is experiencing a period of steady growth, driven by several key factors. Diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID), is widely used for managing pain and inflammatory disorders such as arthritis, musculoskeletal pain, and post-surgical discomfort.

Market Size and Forecast

• The global diclofenac sodium market was valued at USD 2.5 billion in 2024 and is projected to reach USD 3.7 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.5% from 2024 to 2031[1].
• Another report indicates that the market size was valued at USD 1.5 billion in 2023 and is expected to reach USD 2.048 billion by 2031, growing at a CAGR of 4% from 2024 to 2031[4].

Key Drivers

Rising Prevalence of Chronic Pain and Inflammatory Disorders

The increasing prevalence of chronic pain conditions such as arthritis, migraines, and fibromyalgia is a significant driver for the diclofenac sodium market. The World Health Organization (WHO) estimates that chronic diseases afflict over a billion people worldwide, creating a vast target demographic for diclofenac sodium[3].

Increasing Geriatric Population

The growing geriatric population is more susceptible to degenerative joint diseases like osteoarthritis and rheumatoid arthritis, which are commonly treated with diclofenac sodium. This demographic shift is a pivotal growth driver for the market[3].

Advancements in Pharmaceutical Formulations

Advances in drug formulation technologies, such as topical gels and extended-release tablets, have improved the therapeutic effects and patient compliance of diclofenac sodium. These formulations enhance the market by offering more effective and convenient treatment options[4].

Expansion into Emerging Markets

Emerging markets in regions like Asia-Pacific and Africa present lucrative opportunities for diclofenac sodium due to large populations with unmet medical needs. Increasing healthcare spending and growing awareness of treatment options in these regions are key drivers for market growth[3].

Market Segmentation

By Type

• The market is segmented into tablets and injections, with tablets holding the major share due to their widespread prescription and higher demand compared to injections[1].

By Application

• The market is segmented into elderly and adult populations, with the elderly segment holding a significant share due to their higher susceptibility to chronic illnesses and lower immune systems[1].

By Geography

• North America is expected to dominate the market due to factors such as an expanding senior population, rising prevalence of cardiovascular illnesses, and high healthcare expenditure. However, Asia-Pacific is also a significant player, holding a 35.5% market share valued at USD 1.5 billion, driven by increasing healthcare expenditure and growing populations[1][3].

Competitive Landscape

Key Players

• Companies like Auro Laboratories Limited, Henan Dongtai Pharmaceutical Co., Dr. Reddy’s Laboratories, and Perrigo Company plc are key players in the diclofenac sodium market. These companies are involved in various strategic developments, including the launch of generic and over-the-counter (OTC) versions of diclofenac sodium products[1][2].

Recent Developments

• In September 2020, Dr. Reddy’s Laboratories introduced an OTC diclofenac sodium topical gel in the United States, which is a generic version of Novartis Corporation’s Voltaren gel[1].
• In February 2020, Perrigo Company plc received FDA approval for its OTC diclofenac sodium topical gel 1%, which is marketed under retailer’s store brand labels[2].

Challenges and Restraints

Side Effects and Patent Expirations

• Anti-inflammatory medicine side effects and drug patent expirations can hamper industry expansion. There is a growing demand for new anti-inflammatory treatments with fewer side effects and improved efficacy, which presents both challenges and opportunities for market growth[1].

Regulatory Frameworks

• Stringent regulatory frameworks, especially in regions like North America, can slightly temper market growth. However, these frameworks also drive innovation and the development of safer, more effective treatments[3].

Financial Performance and Projections

• The diclofenac sodium market is expected to grow significantly, with a projected market size of USD 3.7 billion by 2031 from USD 2.5 billion in 2024, at a CAGR of 4.5%[1].
• Another projection indicates that the market will grow from USD 1.5 billion in 2023 to USD 2.048 billion by 2031, at a CAGR of 4%[4].

Distribution Channels

• Retail pharmacy dominates the distribution channels with a significant market share, highlighting the importance of accessible and convenient retail outlets for diclofenac sodium products[3].

Key Takeaways

• The diclofenac sodium market is driven by the rising prevalence of chronic pain and inflammatory disorders, an increasing geriatric population, and advancements in pharmaceutical formulations.
• The market is segmented by type, application, and geography, with tablets and the elderly population being significant segments.
• North America and Asia-Pacific are key regions, with the latter dominating due to its large population and growing healthcare expenditure.
• The market faces challenges from side effects and patent expirations but also presents opportunities for innovation and growth.

FAQs

Q: What is the projected market size of the diclofenac sodium market by 2031?

A: The diclofenac sodium market is projected to reach USD 3.7 billion by 2031 from USD 2.5 billion in 2024, growing at a CAGR of 4.5%[1].

Q: Which region dominates the diclofenac sodium market?

A: Asia-Pacific dominates the diclofenac sodium market with a 35.5% share, valued at USD 1.5 billion[3].

Q: What are the main drivers of the diclofenac sodium market?

A: The main drivers include the rising prevalence of chronic pain and inflammatory disorders, an increasing geriatric population, and advancements in pharmaceutical formulations[3].

Q: Which type of diclofenac sodium product holds the major market share?

A: Tablets hold the major share in the diclofenac sodium market due to their widespread prescription and higher demand compared to injections[1].

Q: What are some recent developments in the diclofenac sodium market?

A: Recent developments include the launch of OTC diclofenac sodium topical gels by companies like Dr. Reddy’s Laboratories and Perrigo Company plc[1][2].

Sources

1. Verified Market Research: Diclofenac Sodium Market Size, Share, Trends & Forecast[1].
2. BioSpace: Perrigo Announces FDA Approval for the Store Brand Equivalent of Voltaren Arthritis Pain[2].
3. Market.US: Diclofenac Market Size, Share, Growth | CAGR of 4.3%[3].
4. Market Research Intellect: Diclofenac Sodium Market Size, Share, Growth | Global Report, 2031[4].