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Last Updated: December 22, 2024

BROMFENAC SODIUM Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Bromfenac Sodium

A generic version of BROMFENAC SODIUM was approved as bromfenac sodium by SENTISS on January 22nd, 2014.

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Recent Clinical Trials for BROMFENAC SODIUM

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SponsorPhase
Seoul National University HospitalPhase 2
Sun Yat-sen UniversityN/A
Ministry of Health, ChinaN/A

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Pharmacology for BROMFENAC SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for BROMFENAC SODIUM
Paragraph IV (Patent) Challenges for BROMFENAC SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BROMSITE Ophthalmic Solution bromfenac sodium 0.075% 206911 1 2017-10-25
PROLENSA Ophthalmic Solution bromfenac sodium 0.07% 203168 1 2013-07-26

US Patents and Regulatory Information for BROMFENAC SODIUM

BROMFENAC SODIUM is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 214340-001 Jul 8, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 202620-001 Jun 23, 2014 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amring Pharms BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 202030-001 Jan 9, 2013 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 206027-001 Nov 22, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 201941-001 Feb 10, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sentiss BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203395-001 Jan 22, 2014 AT2 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 202903-001 Aug 15, 2023 AT2 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

BROMFENAC SODIUM Market Analysis and Financial Projection Experimental

Bromfenac Sodium Market Dynamics and Financial Trajectory

Market Introduction

Bromfenac sodium, a nonsteroidal anti-inflammatory drug (NSAID), is widely used for the symptomatic treatment of inflammatory diseases in the external and anterior ocular areas. Its mechanism of action involves inhibiting cyclooxygenase 1 and 2, thereby blocking prostaglandin synthesis, which are mediators of intraocular inflammation[5].

Market Growth Drivers

The bromfenac sodium market is poised for significant growth driven by several key factors:

Rising Incidences of Allergic Diseases

The increasing prevalence of allergic diseases and other ocular inflammatory conditions is a major driver for the market. As the population ages and the incidence of eye surgeries such as cataract surgeries rises, the demand for effective anti-inflammatory treatments like bromfenac sodium is expected to increase[1].

Increasing R&D Expenditure

Pharmaceutical companies are investing heavily in research and development, which includes the development and improvement of ophthalmic drugs like bromfenac sodium. This increased R&D expenditure is expected to lead to new product launches and enhancements, further driving market growth[1].

Emerging Biopharmaceutical Industries

The growth of biopharmaceutical industries in emerging nations is another significant factor. These regions offer lucrative opportunities due to their large patient populations and growing healthcare infrastructure[1].

Market Segmentation

The global bromfenac sodium market is segmented based on several criteria:

By Type

The market is segmented into original drugs and generic drugs. The generic segment is expected to grow significantly due to its cost-effectiveness and the expiration of patents for original drugs[1][4].

By Distribution Channel

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to dominate the market due to the high volume of surgical procedures performed in these settings[1][4].

Regional Framework

The market is analyzed across five major regions: North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region is further sub-segmented by country to provide a detailed overview of the market dynamics.

  • North America: This region is expected to hold a significant share due to advanced healthcare infrastructure and high adoption rates of new treatments.
  • Asia-Pacific: The APAC region is anticipated to show rapid growth due to the large patient population and increasing healthcare expenditure in countries like China and India[1][4].

Financial Trajectory

Market Size and Forecast

The global bromfenac sodium market was valued at US$ million in 2023 and is anticipated to reach US$ million by 2030, witnessing a significant Compound Annual Growth Rate (CAGR) during the forecast period of 2024-2030[4].

Revenue Forecast

The market size and revenue forecasts are provided in terms of sales volume (Kg) and revenue ($ millions), with historical data from 2019 to 2023 and forecast data from 2024 to 2030. This comprehensive analysis helps in understanding the market's financial trajectory and making informed business decisions[4].

Key Players and Competitive Landscape

The market is dominated by several key players, including Qilu Pharma, Senju Pharma, CISEN, Hi-Tech Pharma, Apotex Corp., Iskon Remedies, and Meizilin Pharma. These companies are focusing on organic growth strategies such as product launches and approvals, as well as inorganic strategies like acquisitions and partnerships to expand their market share[1][4].

Clinical Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of bromfenac sodium. For instance, two phase 3 clinical trials showed that bromfenac ophthalmic solution 0.07% was clinically safe and effective in treating ocular inflammation and pain after cataract surgery, with a higher proportion of subjects achieving complete clearance of ocular inflammation and being pain-free compared to the placebo group[2][5].

Technological Trends and New Product Developments

The market is also driven by technological trends and new product developments. Advances in drug delivery systems and the development of new formulations are expected to enhance the market's growth potential. For example, the availability of bromfenac ophthalmic solution in different concentrations (e.g., 0.07% and 0.09%) caters to various clinical needs and improves patient outcomes[5].

Challenges and Restraints

Despite the growth drivers, the market faces some challenges:

  • Regulatory Requirements: Strict regulatory requirements and the need for extensive clinical trials can slow down the approval process for new products.
  • Side Effects: Although rare, side effects such as corneal erosion, corneal perforation, and epithelial breakdown can impact market growth[5].

PEST Analysis

A comprehensive PEST (Political, Economic, Social, and Technological) analysis is crucial for understanding the broader environment in which the bromfenac sodium market operates.

  • Political: Government policies and regulations play a significant role in the pharmaceutical industry. Favorable policies can boost market growth.
  • Economic: Economic factors such as healthcare expenditure and reimbursement policies influence the market's financial trajectory.
  • Social: Increasing awareness about eye health and the growing aging population are social factors driving the market.
  • Technological: Advances in medical technology and drug delivery systems are key technological factors[1].

Key Takeaways

  • The bromfenac sodium market is expected to grow significantly due to rising incidences of allergic diseases and increasing R&D expenditure.
  • The market is segmented into original and generic drugs, with generic drugs expected to grow rapidly.
  • Key players are focusing on both organic and inorganic growth strategies.
  • Clinical trials have demonstrated the efficacy and safety of bromfenac sodium.
  • Technological trends and new product developments are enhancing market growth.

FAQs

Q: What is bromfenac sodium used for? Bromfenac sodium is used for the symptomatic treatment of inflammatory diseases in the external and anterior ocular areas, particularly for conditions such as ocular inflammation and pain after cataract surgery[1][5].

Q: What are the key drivers of the bromfenac sodium market? The key drivers include rising incidences of allergic diseases, increasing R&D expenditure, and the growth of biopharmaceutical industries in emerging nations[1].

Q: Which regions are expected to dominate the bromfenac sodium market? North America and Asia-Pacific are expected to be the dominant regions due to advanced healthcare infrastructure and a large patient population, respectively[1][4].

Q: What are the common side effects of bromfenac sodium? Common side effects include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown, although these are rare[5].

Q: How is the bromfenac sodium market segmented? The market is segmented by type (original and generic drugs) and distribution channel (hospital pharmacies, retail pharmacies, and online pharmacies)[1][4].

Sources

  1. The Insight Partners, "Bromfenac Sodium Market Key Players Analysis 2031"
  2. PubMed, "Bromfenac ophthalmic solution 0.07% dosed once daily for cataract surgery"
  3. Stats and Data, "Global Bromfenac Sodium Market Industry Best Practices 2024-2031"
  4. OpenPR, "Global Bromfenac Sodium Market Report 2024: Emerging Trends"
  5. DailyMed, "BROMFENAC- bromfenac sodium solution/ drops"

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