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Last Updated: December 26, 2024

Ibuprofen sodium - Generic Drug Details


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What are the generic sources for ibuprofen sodium and what is the scope of freedom to operate?

Ibuprofen sodium is the generic ingredient in two branded drugs marketed by Haleon Us Holdings and Perrigo R And D, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for ibuprofen sodium. One supplier is listed for this compound.

Summary for ibuprofen sodium
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 45
Clinical Trials: 39
Patent Applications: 7,161
What excipients (inactive ingredients) are in ibuprofen sodium?ibuprofen sodium excipients list
DailyMed Link:ibuprofen sodium at DailyMed
Recent Clinical Trials for ibuprofen sodium

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

SponsorPhase
CMC Ambroise ParéN/A
Universitat Internacional de CatalunyaPhase 4
Ajman UniversityPhase 4

See all ibuprofen sodium clinical trials

Pharmacology for ibuprofen sodium

US Patents and Regulatory Information for ibuprofen sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Haleon Us Holdings ADVIL ibuprofen sodium TABLET;ORAL 201803-001 Jun 12, 2012 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Perrigo R And D IBUPROFEN SODIUM ibuprofen sodium TABLET;ORAL 206581-001 Aug 3, 2015 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

Ibuprofen sodium Market Analysis and Financial Projection Experimental

Ibuprofen Sodium Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The ibuprofen market, which includes ibuprofen sodium, is experiencing significant growth driven by several key factors. According to recent projections, the global ibuprofen market was valued at USD 1.43 billion in 2023 and is expected to reach USD 1.76 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 2.44% during the forecast period[3].

For the ibuprofen sodium API specifically, the market is part of this broader trend, with the global pharmaceutical market, which includes APIs, growing at a CAGR of 5% over the next six years[4].

Key Drivers of Growth

Increasing Prevalence of Chronic Pain

The rising prevalence of chronic pain conditions such as rheumatoid arthritis, osteoarthritis, and other musculoskeletal disorders is a major driver of the ibuprofen market. An aging population, particularly in regions like Asia-Pacific, is more prone to these conditions, thereby increasing the demand for pain management solutions like ibuprofen sodium[3].

Self-Medication and OTC Market

The trend towards self-medication and the growing preference for over-the-counter (OTC) medications are significant drivers. Consumers are increasingly opting for OTC pain relief options, which has led to an expansion in the OTC segment of the ibuprofen market[1].

Urbanization and Healthcare Spending

Rising urbanization and increased healthcare spending, especially in emerging markets, are also contributing to the growth of the ibuprofen market. Regions like Asia-Pacific, with cost-efficient manufacturing and rising healthcare expenditures, are expected to see substantial growth[3].

Market Segmentation

Dosage Forms

The ibuprofen market, including ibuprofen sodium, is segmented by dosage forms such as tablets, capsules, syrups, injections, and others. In 2023, tablets dominated the market with a 41.6% share due to their convenience[1].

Applications

The largest application segments for ibuprofen include rheumatoid arthritis and osteoarthritis, which accounted for a 30.8% market share in 2023. Other significant applications include cancer-related pain and general pain relief[1].

Regional Insights

Asia-Pacific is the largest market shareholder and is expected to expand substantially during the forecast period. North America, however, is the fastest-growing market, driven by advanced healthcare systems and a focus on effective pain management[3].

Key Players and Competitive Landscape

Major Players

The ibuprofen sodium API market is dominated by key players such as Solara Active Pharma Sciences, BASF, Hubei Biocause Group, IOL Chemicals and Pharmaceuticals, and Olon S.p.A[4].

Strategic Initiatives

Companies are engaging in strategic collaborations and investments to enhance their market positions. For example, Solara Active Pharma Sciences has inaugurated a new manufacturing facility and merged with Aurore Life to expand its product portfolio and improve its cost leadership in ibuprofen[1][2].

Cost Leadership and Innovation

Solara Active Pharma Sciences, in particular, has cost leadership in ibuprofen and is well-positioned to capitalize on the growing API market. The company's recent capex at its Vizag facility is expected to significantly improve its capacity, including for ibuprofen[2].

Regulatory and Competitive Challenges

Regulatory Impact

Stringent regulatory standards and strict approval processes pose significant challenges for new ibuprofen products entering the market. Regulatory hurdles, such as warning letters or import alerts, can negatively impact companies like Solara Active Pharma Sciences, which has faced inspection issues at its Puducherry plant[2].

Market Competition

The market is highly competitive, with generic brands and alternative pain management therapies intensifying competition. This leads to price reductions and narrower profit margins for manufacturers[1].

Innovative Trends

Combination Therapies

The market is witnessing a shift towards combination therapies, which offer enhanced efficacy and convenience. New formulations, such as ibuprofen cystamine salts with improved solubility and anti-inflammatory effects, are being developed to address these needs[5].

Sustainable Packaging

There is a growing trend towards eco-friendly packaging, which presents both a challenge and an opportunity for manufacturers. Companies must balance consumer demands for sustainability with the clinical effectiveness of their products[1].

Digital Marketing and Personalized Medicine

Digital marketing strategies and the move towards personalized medicine are also influencing the market. These trends help companies to better target their products and enhance patient outcomes[1].

Financial Trajectory

Revenue Growth

The revenue growth for the ibuprofen market is substantial, with the global market expected to grow from USD 1.43 billion in 2023 to USD 1.76 billion by 2032. For Solara Active Pharma Sciences, revenue is expected to grow at a CAGR of 35.9% over the forecast period, driven by market share gains in existing products and new product launches[2].

Profit Margins and EPS

Despite the competitive landscape, companies like Solara Active Pharma Sciences are expected to maintain healthy profit margins. The company is projected to register an EPS CAGR of 20.3% over the forecast period, although this is lower than the PAT CAGR due to equity dilution from the Aurore merger[2].

Regional Expansion Opportunities

Emerging Markets

Emerging markets, particularly in Asia-Pacific, offer significant opportunities for growth. The cost-efficient manufacturing environment and rising healthcare expenditures in countries like China and India make these regions attractive for ibuprofen manufacturers[3].

North America

North America, with its advanced healthcare systems and focus on effective pain management, is also a key region for growth. Companies are expanding their production capacities and investing in new facilities to meet the growing demand in this region[1].

Key Takeaways

  • The ibuprofen market, including ibuprofen sodium, is projected to grow significantly, driven by an aging population, increasing chronic pain prevalence, and the trend towards self-medication.
  • Key players like Solara Active Pharma Sciences, BASF, and Hubei Biocause Group are leveraging strategic initiatives and cost leadership to maintain their market positions.
  • Regulatory challenges and competition from generic brands and alternative therapies are significant hurdles that companies must navigate.
  • Innovative trends such as combination therapies, sustainable packaging, and digital marketing are shaping the market.
  • Emerging markets and North America offer substantial growth opportunities.

FAQs

What is the projected market size of the global ibuprofen market by 2032?

The global ibuprofen market is expected to reach USD 1.76 billion by 2032, growing at a CAGR of 2.44% from 2023[3].

Which region dominates the global ibuprofen market?

Asia-Pacific is the largest market shareholder for ibuprofen, driven by cost-efficient manufacturing and rising healthcare expenditures in countries like China and India[3].

What are the main drivers of the ibuprofen market growth?

Key drivers include the increasing prevalence of chronic pain, the trend towards self-medication, and rising healthcare spending, especially in emerging markets[1][3].

Who are the major players in the ibuprofen sodium API market?

Major players include Solara Active Pharma Sciences, BASF, Hubei Biocause Group, IOL Chemicals and Pharmaceuticals, and Olon S.p.A[4].

What are the challenges faced by ibuprofen manufacturers?

Manufacturers face challenges such as stringent regulatory standards, competition from generic brands and alternative therapies, and the need to balance consumer demands for sustainability with product effectiveness[1][2].

Sources

  1. Ibuprofen Market Valuation to Climb to USD 205.6 Million by 2033 - Media Market US
  2. Solara Active Pharma Sciences - ICICI Securities
  3. Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report - Straits Research
  4. Ibuprofen Sodium API - Market, Report Size, Worth, Revenue - Valuates Reports
  5. New Ibuprofen Cystamine Salts With Improved Solubility and Anti-Inflammatory Effect - ResearchGate

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