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Last Updated: December 25, 2024

Diclofenac potassium - Generic Drug Details


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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.

Drug Prices for diclofenac potassium

See drug prices for diclofenac potassium

Recent Clinical Trials for diclofenac potassium

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

SponsorPhase
Danish Headache CenterPhase 4
Fayoum University HospitalPhase 4
Cairo UniversityN/A

See all diclofenac potassium clinical trials

Pharmacology for diclofenac potassium
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
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 AB RX Yes Yes 7,759,394 ⤷  Subscribe Y Y ⤷  Subscribe
Teva DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075219-001 Aug 6, 1998 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Senores Pharms DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 215787-001 Mar 15, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for diclofenac potassium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 7,482,377 ⤷  Subscribe
Assertio ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 6,287,594 ⤷  Subscribe
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 6,974,595 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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 ...

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