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Last Updated: December 22, 2024

DICLOFENAC SODIUM AND MISOPROSTOL Drug Patent Profile


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Which patents cover Diclofenac Sodium And Misoprostol, and what generic alternatives are available?

Diclofenac Sodium And Misoprostol is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Exela Holdings, Micro Labs, Sandoz, Yung Shin Pharm, and Zydus Pharms. and is included in seven NDAs.

The generic ingredient in DICLOFENAC SODIUM AND MISOPROSTOL is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Diclofenac Sodium And Misoprostol

A generic version of DICLOFENAC SODIUM AND MISOPROSTOL was approved as diclofenac sodium; misoprostol by ACTAVIS LABS FL INC on July 9th, 2012.

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Summary for DICLOFENAC SODIUM AND MISOPROSTOL
US Patents:0
Applicants:7
NDAs:7
Finished Product Suppliers / Packagers: 10
Raw Ingredient (Bulk) Api Vendors: 4
Patent Applications: 1
What excipients (inactive ingredients) are in DICLOFENAC SODIUM AND MISOPROSTOL?DICLOFENAC SODIUM AND MISOPROSTOL excipients list
DailyMed Link:DICLOFENAC SODIUM AND MISOPROSTOL at DailyMed
Drug patent expirations by year for DICLOFENAC SODIUM AND MISOPROSTOL
Pharmacology for DICLOFENAC SODIUM AND MISOPROSTOL

US Patents and Regulatory Information for DICLOFENAC SODIUM AND MISOPROSTOL

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 201089-001 Jul 9, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Micro Labs DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 204355-001 Jul 15, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amneal Pharms DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 203995-002 Nov 25, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Yung Shin Pharm DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 205143-002 Feb 19, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Micro Labs DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 204355-002 Jul 15, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 206771-002 Jun 12, 2023 DISCN 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

DICLOFENAC SODIUM AND MISOPROSTOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diclofenac Sodium and Misoprostol

Introduction

Diclofenac sodium and misoprostol, a combination of a nonsteroidal anti-inflammatory drug (NSAID) and a prostaglandin E1 analog, are widely used for managing pain and inflammatory disorders such as rheumatoid arthritis, osteoarthritis, and other musculoskeletal conditions. Here, we delve into the market dynamics and financial trajectory of this drug combination.

Market Size and Forecast

The global market for diclofenac sodium is experiencing steady growth. As of 2024, the market was valued at USD 2.5 billion and is projected to reach USD 3.7 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.5%[2][3].

Another projection indicates that the market size was valued at USD 4.2 billion in 2023 and is expected to reach USD 6.4 billion by 2033, with a CAGR of 4.3% during the forecast period[3].

Market Segmentation

The diclofenac sodium market is segmented into several key categories:

By Type

  • Tablets dominate the market, holding a significant share due to their widespread prescription and higher demand compared to injections. Tablets account for approximately 55.5% of the market share[2][3].

By Application

  • The market is segmented into elderly and adult populations, with the elderly segment holding a substantial share due to their higher susceptibility to chronic illnesses and lower immune systems[2].

By Geography

  • North America is expected to dominate the market, driven by factors such as an expanding senior population, rising prevalence of cardiovascular illnesses, and high healthcare expenditure. However, the Asia-Pacific region 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[2][3].

Key Drivers

Several factors are driving the growth of the diclofenac sodium market:

Rising Prevalence of Chronic Pain and Inflammatory Disorders

  • The increasing incidence of arthritis, musculoskeletal pain, and post-surgical discomfort is a major driver. The growing geriatric population, which is more susceptible to these conditions, further fuels market growth[2][3].

Advancements in Pharmaceutical Formulations

  • Improvements in drug formulation technologies have enhanced the delivery and efficacy of diclofenac sodium, making it a preferred choice for pain management[3].

Expansion into Emerging Markets

  • Emerging markets in regions like Asia-Pacific and Africa present lucrative opportunities due to large populations with unmet medical needs and increasing healthcare spending[2][3].

Challenges and Restraints

Despite the growth, the market faces several challenges:

Side Effects and Patent Expirations

  • Diclofenac sodium is associated with serious cardiovascular and gastrointestinal side effects, which can hamper market growth. Additionally, patent expirations can lead to increased competition from generic versions[1][2].

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[2][3].

Financial Performance and Projections

The financial performance of the diclofenac sodium market is robust:

  • The 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%[2].
  • Another projection indicates the market will grow from USD 4.2 billion in 2023 to USD 6.4 billion by 2033, at a CAGR of 4.3%[3].

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. Retail pharmacy accounts for approximately 68.4% of the market share[3].

Economic Implications

The combination of diclofenac sodium and misoprostol has favorable economic implications:

  • Economic analyses have shown that diclofenac/misoprostol is associated with similar or lower total direct medical treatment costs compared to other NSAIDs. This is particularly beneficial for patients at high risk of developing NSAID-associated gastroduodenal ulcers, such as the elderly[5].

Clinical Efficacy and Safety

Diclofenac sodium, especially when combined with misoprostol, has been shown to be effective in managing the signs and symptoms of rheumatoid arthritis and osteoarthritis. Misoprostol significantly reduces the incidence of NSAID-induced gastric and duodenal ulcers, making the combination a safer option for long-term NSAID therapy[1][4].

Regional Growth

The Asia-Pacific region is a significant player in the diclofenac sodium market, driven by increasing healthcare expenditure, rising awareness of pain management solutions, and growing populations. Middle East & Africa and Latin America are also emerging as promising markets due to gradual improvements in healthcare infrastructure and growing middle-class populations[2][3].

Key Takeaways

  • The global diclofenac sodium market is projected to grow from USD 2.5 billion in 2024 to USD 3.7 billion by 2031, at a CAGR of 4.5%.
  • The Asia-Pacific region dominates the market with a 35.5% share, valued at USD 1.5 billion.
  • Tablets lead the market with a 55.5% share due to their widespread prescription and higher demand.
  • The elderly population segment holds a significant share due to their higher susceptibility to chronic illnesses.
  • Retail pharmacy dominates the distribution channels with a 68.4% market share.

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%[2].

Q: Which region dominates the diclofenac sodium market? A: The Asia-Pacific region dominates the diclofenac sodium market with a 35.5% share, valued at USD 1.5 billion[2][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[2][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[2][3].

Q: How does the combination of diclofenac sodium and misoprostol impact medical treatment costs? A: Economic analyses have shown that diclofenac/misoprostol is associated with similar or lower total direct medical treatment costs compared to other NSAIDs, particularly beneficial for patients at high risk of developing NSAID-associated gastroduodenal ulcers[5].

Cited Sources:

  1. pms-DICLOFENAC-MISOPROSTOL Product Monograph.
  2. DrugPatentWatch - DICLOFENAC SODIUM.
  3. Market.us - Diclofenac Market Size, Share, Growth.
  4. FDA - ARTHROTEC (diclofenac sodium/misoprostol) Tablets.
  5. PubMed - Diclofenac/misoprostol. Pharmacoeconomic implications of therapy.

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