DICLOFENAC POTASSIUM - Generic Drug Details

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

Diclofenac potassium is the generic ingredient in four branded drugs marketed by Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Assertio, Alkem Labs Ltd, Annora Pharma, Endo Operations, Taro, Amici Pharma, Novartis, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon, Senores Pharms, Sun Pharm Industries, Teva, Umedica, and Watson Labs Teva, and is included in twenty NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are eleven drug master file entries for diclofenac potassium. Forty-two suppliers are listed for this compound.

Summary for DICLOFENAC POTASSIUM

International Patents:	34
US Patents:	10
Tradenames:	4
Applicants:	19
NDAs:	20
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	33
Patent Applications:	6,823
Drug Prices:	Drug price trends for DICLOFENAC POTASSIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DICLOFENAC POTASSIUM
What excipients (inactive ingredients) are in DICLOFENAC POTASSIUM?	DICLOFENAC POTASSIUM excipients list
DailyMed Link:	DICLOFENAC POTASSIUM at DailyMed

See drug prices for DICLOFENAC POTASSIUM

Recent Clinical Trials for DICLOFENAC POTASSIUM

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

Sponsor	Phase
Danish Headache Center	Phase 4
Fayoum University Hospital	Phase 4
Cairo University	N/A

See all DICLOFENAC POTASSIUM clinical trials

Pharmacology for DICLOFENAC POTASSIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for DICLOFENAC POTASSIUM

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 POTASSIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZIPSOR	Capsules	diclofenac potassium	25 mg	022202	1	2012-11-14
CAMBIA	Oral Solution (Sachet)	diclofenac potassium	50 mg	022165	1	2011-01-24

US Patents and Regulatory Information for DICLOFENAC POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	DICLOFENAC POTASSIUM	diclofenac potassium	FOR SOLUTION;ORAL	216635-001	Jul 20, 2022	AB	RX	No	No
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes			Y
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes
Novartis	CATAFLAM	diclofenac potassium	TABLET;ORAL	020142-001	Nov 24, 1993		DISCN	Yes	No
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	AB	RX	Yes	Yes
Rubicon	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075229-002	Sep 16, 2021	AB	RX	No	No

Expired US Patents for DICLOFENAC POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009

International Patents for DICLOFENAC POTASSIUM

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2402003	Formulations de diclofénac et procédés d'utilisation (Diclofenac formulations and methods of use)
Brazil	PI0612245	formulações de diclofenaco e métodos de uso
European Patent Office	1890680	PREPARATIONS DE DICLOFENAC ET LEURS METHODES D'UTILISATION (DICLOFENAC FORMULATIONS AND METHODS OF USE)
Hong Kong	1213814	雙氯芬酸製劑和使用方法 (DICLOFENAC FORMULATIONS AND METHODS OF USE)
European Patent Office	2705837	Formulations de diclofénac (Diclofenac Formulation)
Norway	20080352

DICLOFENAC POTASSIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diclofenac Potassium

Market Overview

Diclofenac potassium, a non-steroidal anti-inflammatory drug (NSAID), is a pivotal player in the global pharmaceutical market, particularly in the management of pain and inflammatory disorders. Here’s a comprehensive look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global diclofenac potassium market is projected to experience significant growth over the coming years. As of 2023, the market size was valued at USD 5.57 billion and is expected to reach USD 9.07 billion by 2031, growing at a compound annual growth rate (CAGR) of 4.9% from 2024 to 2031[1].

Similarly, the broader diclofenac market, which includes various formulations, is expected to grow from USD 4.2 billion in 2023 to USD 6.4 billion by 2033, at a CAGR of 4.3% during the forecast period[3].

Driving Factors

Rising Prevalence of Chronic Pain and Inflammatory Disorders

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

Geriatric Population and Joint Diseases

The growing geriatric population, which is more susceptible to degenerative joint diseases like osteoarthritis and rheumatoid arthritis, is another significant growth driver. This demographic shift increases the demand for effective pain management solutions like diclofenac potassium[3].

Advancements in Drug Formulations and Delivery Systems

Innovations in drug formulations and delivery systems enhance patient compliance and the efficacy of diclofenac potassium. These advancements, such as liquid-filled capsules and oral solutions, improve the drug's onset of action and overall effectiveness[2].

Consumer Preference for NSAIDs

Consumers' increasing inclination towards non-steroidal anti-inflammatory medicines (NSAIDs) due to their established safety and effectiveness profiles also supports the market's growth. The expanding over-the-counter availability of diclofenac potassium further boosts its market share[1].

Regional Analysis

Asia Pacific

The Asia Pacific region dominates the diclofenac market with a 35.5% share, valued at USD 1.5 billion. This region's growth is driven by increasing healthcare expenditure, rising awareness of pain management solutions, and growing populations in countries like China and India[3].

North America and Europe

North America and Europe are significant players in the diclofenac market, supported by advanced healthcare infrastructure and high awareness of pain management therapies. However, stringent regulatory frameworks and the rising adoption of biologics may slightly temper market growth in these regions[3].

Middle East & Africa and Latin America

These regions are emerging as promising markets for diclofenac, driven by gradual improvements in healthcare infrastructure and growing middle-class populations with access to medical care. Although they currently contribute less to the global market, they exhibit potential for high growth[3].

Product Segments and Applications

Formulations

Diclofenac potassium is available in various formulations, including tablets, gel, injection, and powder. Tablets lead the market with a significant share, followed by other forms that cater to different patient needs and preferences[1].

Applications

The drug is used for several applications, including pain relief, anti-inflammatory treatment, fever reduction, and osteoarthritis treatment. Osteoarthritis indications account for a substantial portion of diclofenac usage, highlighting its efficacy in managing joint-related pain and inflammation[1][3].

Financial Performance and Key Players

Revenue and Sales

Diclofenac potassium products have been steady contributors to the revenues of pharmaceutical companies. For example, Depomed's Zipsor (diclofenac potassium) liquid-filled capsules reported full-year 2014 sales of $25.2 million, up 24% from 2013, with gross margins over 95%[2].

Acquisitions and Market Expansion

Companies like Depomed have expanded their market presence through strategic acquisitions. The acquisition of CAMBIA (diclofenac potassium for oral solution) by Depomed is expected to be immediately accretive, reflecting the financial attractiveness of the diclofenac potassium market[5].

Challenges and Opportunities

Regulatory Landscapes

Stringent regulatory frameworks, especially in regions like North America and Europe, can pose challenges to market growth. However, these regulations also drive innovation and ensure the safety and efficacy of diclofenac potassium products[3].

Generic Penetration

The expiration of patents and the increasing penetration of generic versions can impact the market share of branded diclofenac potassium products. However, this also presents opportunities for companies to expand their generic portfolios and reach a broader market[3].

Key Takeaways

• Market Growth: The diclofenac potassium market is expected to grow significantly, driven by the rising prevalence of chronic pain and inflammatory disorders.
• Regional Dominance: Asia Pacific leads the market, followed by North America and Europe.
• Product Innovations: Advancements in drug formulations and delivery systems are crucial for market expansion.
• Financial Performance: Diclofenac potassium products contribute substantially to the revenues of pharmaceutical companies.

FAQs

What is the expected market size of the diclofenac potassium market by 2031?

The diclofenac potassium market is expected to reach USD 9.07 billion by 2031[1].

Which region dominates the diclofenac market?

The Asia Pacific region dominates the diclofenac market with a 35.5% share[3].

What are the primary applications of diclofenac potassium?

Diclofenac potassium is primarily used for pain relief, anti-inflammatory treatment, fever reduction, and osteoarthritis treatment[1].

How do advancements in drug formulations impact the market?

Advancements in drug formulations and delivery systems enhance patient compliance and the efficacy of diclofenac potassium, driving market growth[2].

What are the key challenges facing the diclofenac potassium market?

Stringent regulatory frameworks and the increasing penetration of generic versions are key challenges, but they also present opportunities for innovation and market expansion[3].

Cited Sources

1. Market Research Intellect - Diclofenac Potassium Market Size, Share - Market Research Intellect
2. Annual Reports - Untitled - Annual Reports
3. Market.US - Diclofenac Market Size, Share, Growth | CAGR of 4.3%
4. Cognitive Market Research - Global Diclofenac Potassium Market Report 2024 Edition
5. FirstWord Pharma - Depomed Acquires CAMBIA (Diclofenac Potassium for Oral Solution ...