VOLTAREN Drug Patent Profile

Which patents cover Voltaren, and what generic alternatives are available?

Voltaren is a drug marketed by Novartis and Haleon Us Holdings and is included in four NDAs.

The generic ingredient in VOLTAREN is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-seven suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Voltaren

A generic version of VOLTAREN was approved as diclofenac sodium by ACTAVIS ELIZABETH on March 26^th, 1996.

Summary for VOLTAREN

US Patents:	0
Applicants:	2
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	56
Patent Applications:	4,203
Drug Prices:	Drug price information for VOLTAREN
Drug Sales Revenues:	Drug sales revenues for VOLTAREN
What excipients (inactive ingredients) are in VOLTAREN?	VOLTAREN excipients list
DailyMed Link:	VOLTAREN at DailyMed

See drug prices for VOLTAREN

See drug sales revenues for VOLTAREN

Recent Clinical Trials for VOLTAREN

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

Sponsor	Phase
Washington State University	Early Phase 1
University of Rijeka	N/A
German University in Cairo	Phase 2

See all VOLTAREN clinical trials

Pharmacology for VOLTAREN

Drug Class	Anti-coagulant Calculi Dissolution Agent
Mechanism of Action	Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity

US Patents and Regulatory Information for VOLTAREN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037-001	Mar 28, 1991		DISCN	Yes	No
Novartis	VOLTAREN	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	019201-003	Jul 28, 1988		DISCN	Yes	No
Novartis	VOLTAREN	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	019201-001	Jul 28, 1988		DISCN	Yes	No
Novartis	VOLTAREN	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	019201-002	Jul 28, 1988		DISCN	Yes	No
Novartis	VOLTAREN-XR	diclofenac sodium	TABLET, EXTENDED RELEASE;ORAL	020254-001	Mar 8, 1996		DISCN	Yes	No
Haleon Us Holdings	VOLTAREN ARTHRITIS PAIN	diclofenac sodium	GEL;TOPICAL	022122-001	Oct 17, 2007		OTC	Yes	Yes

Expired US Patents for VOLTAREN

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

International Patents for VOLTAREN

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

Country	Patent Number	Title	Estimated Expiration
Japan	2515788
Hong Kong	1394	PHARMACEUTICAL COMPOSITION FOR TREATING INFLAMMATION IN THE EYE
Portugal	84669	PROCESSO PARA A PREPARACAO DE UM MEDICAMENTO PARA O TRATAMENTO DE INFLAMACOES DOS OLHOS CONTENDO DICLOFENAC-SODIO
Greece	3002659
Denmark	176487
Canada	1286225	MEDICAMENT POUR LE TRAITEMENT DES INFLAMMATIONS DE L'OEIL (MEDICAMENT FOR THE TREATMENT OF INFLAMMATIONS OF THE EYE)
Egypt	18268	MEDICAMENT FOR THE TREATMENT OF INFLAMMATION OF THE EYE

VOLTAREN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Voltaren

Introduction to Voltaren

Voltaren, a brand name for the non-steroidal anti-inflammatory drug (NSAID) diclofenac, is a pivotal player in the global pain management market. It is widely used to alleviate pain and reduce inflammation in conditions such as arthritis, muscle pain, and post-operative discomfort. Available in various forms, including topical gels, oral tablets, and injections, Voltaren offers versatile treatment options for different patient needs[1].

Global Market Size and Projections

The Voltaren market is experiencing substantial growth, driven by several key factors. The global market size for Voltaren is projected to reach over $5.5 billion by 2024 and is expected to continue growing at a compound annual growth rate (CAGR) of approximately 5-7% in the coming years[4].

Driving Factors

Rising Prevalence of Chronic Pain and Inflammatory Disorders

The increasing incidence of chronic pain conditions such as arthritis, migraines, and fibromyalgia is a significant driver for the Voltaren market. With over a billion people worldwide affected by chronic diseases, the demand for effective pain relief solutions like Voltaren is escalating[3].

Increasing Geriatric Population

The growing geriatric population is another critical factor. As the population aged 65 and over is projected to double to 1.5 billion by 2050, the demand for pain management solutions for degenerative joint diseases such as osteoarthritis and rheumatoid arthritis is expected to rise significantly[3].

Expansion of Over-the-Counter Availability

Regulatory approvals for over-the-counter (OTC) availability of NSAIDs like Voltaren have made these medications more accessible, eliminating the need for prescriptions and enhancing consumer convenience. This shift has broadened the user base and facilitated higher consumption rates, contributing to the market's growth[3].

Market Segmentation

By Type

The Voltaren market is segmented by type, with tablets leading the market share. Topical gels and other formulations are also gaining traction due to their localized treatment benefits and reduced systemic side effects[1][4].

By Disease Indication

Osteoarthritis indications account for a significant portion of Voltaren usage, followed by rheumatoid arthritis and other conditions. The versatility of Voltaren in treating various pain conditions has contributed to its widespread adoption[3].

By Administration Route

Oral administration remains the preferred route for many users, but topical solutions, injections, and other forms are gaining popularity due to their targeted relief and reduced side effects[3].

By Distribution Channel

Retail pharmacies dominate the distribution channels for Voltaren, with online pharmacies and hospital pharmacies also playing significant roles. The ease of access through these channels has enhanced the market's growth[3].

Financial Performance and Trends

Revenue Growth

The Voltaren market has shown consistent revenue growth, with projections indicating it could reach over $2 billion in value within the next few years. This growth is driven by the increasing demand for effective pain relief solutions and the expanding geriatric population[1].

Regional Performance

Emerging markets, particularly in the Asia-Pacific and Latin America regions, are playing a crucial role in the Voltaren market. Rising disposable incomes, improving healthcare infrastructure, and growing awareness of pain management options are driving demand in these regions[1].

Company Performance

Novartis, the primary manufacturer of Voltaren, has seen mixed financial performance in recent years. While the Voltaren segment has experienced growth, it has also faced declines in certain markets. For instance, in emerging growth markets, Voltaren/Cataflam sales declined by 16% in Q4 2022 compared to the previous year[2].

Innovations and R&D

New Formulations and Delivery Systems

Recent advancements in formulation and delivery technologies have enhanced the effectiveness of Voltaren products. The introduction of topical gels and extended-release formulations has been particularly well-received, offering longer-lasting relief and reduced side effects[1].

Strategic Collaborations

Strategic collaborations between pharmaceutical companies and research institutions are driving innovation within the Voltaren market. These partnerships focus on conducting clinical trials to evaluate new formulations and delivery methods, ensuring that products meet rigorous safety and efficacy standards[1].

Future Outlook

The future of the Voltaren market looks promising, with ongoing research exploring new therapeutic applications. Studies are investigating the use of Voltaren in treating neuropathic pain, postoperative pain, and certain dermatological conditions. As clinical evidence supports these new applications, the acceptance of Voltaren in various medical fields is likely to increase[1].

Key Takeaways

• Market Growth: The Voltaren market is projected to grow significantly, driven by the increasing prevalence of chronic pain conditions and the growing geriatric population.
• Regional Dominance: Asia-Pacific and Latin America are emerging as key regions driving market growth.
• Innovations: New formulations and delivery systems, such as topical gels and extended-release formulations, are enhancing the market.
• Financial Performance: While Novartis has seen mixed results, the overall market is expected to continue growing.

FAQs

Q: What is the primary active ingredient in Voltaren? A: The primary active ingredient in Voltaren is diclofenac, a non-steroidal anti-inflammatory drug (NSAID)[1].

Q: What are the common uses of Voltaren? A: Voltaren is commonly used to alleviate pain and reduce inflammation in conditions such as arthritis, muscle pain, and post-operative discomfort[1].

Q: What is the projected market size for Voltaren by 2024? A: The global Voltaren market size is projected to be around $5.5 billion by 2024[4].

Q: Which regions are driving the growth of the Voltaren market? A: Emerging markets, particularly in the Asia-Pacific and Latin America regions, are driving the growth of the Voltaren market[1].

Q: What are some of the new therapeutic applications being explored for Voltaren? A: Ongoing research is exploring the use of Voltaren in treating neuropathic pain, postoperative pain, and certain dermatological conditions[1].

Cited Sources

1. Market Research Intellect - "Pain Relief Revolution: The Expanding Voltaren Market in Healthcare"
2. Novartis - "Q4 2022 Condensed Financial Report – Supplementary Data"
3. Market.US - "Diclofenac Market Size, Share, Growth | CAGR of 4.3%"
4. Cognitive Market Research - "Voltaren Market Report"