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Last Updated: December 22, 2024

DROXIA Drug Patent Profile


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Which patents cover Droxia, and what generic alternatives are available?

Droxia is a drug marketed by Cheplapharm and is included in one NDA.

The generic ingredient in DROXIA is hydroxyurea. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Droxia

A generic version of DROXIA was approved as hydroxyurea by BARR on October 16th, 1998.

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Summary for DROXIA
Drug patent expirations by year for DROXIA
Drug Prices for DROXIA

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Recent Clinical Trials for DROXIA

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

SponsorPhase
University of ChicagoPhase 1
Mayo ClinicPhase 2
St. Jude Children's Research HospitalPhase 2

See all DROXIA clinical trials

Pharmacology for DROXIA
Drug ClassAntimetabolite

US Patents and Regulatory Information for DROXIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cheplapharm DROXIA hydroxyurea CAPSULE;ORAL 016295-002 Feb 25, 1998 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cheplapharm DROXIA hydroxyurea CAPSULE;ORAL 016295-003 Feb 25, 1998 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cheplapharm DROXIA hydroxyurea CAPSULE;ORAL 016295-004 Feb 25, 1998 DISCN Yes 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

DROXIA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DROXIA and Sickle Cell Disease Treatments

Introduction to Sickle Cell Disease and DROXIA

Sickle Cell Disease (SCD) is a genetic disorder that affects the hemoglobin in red blood cells, leading to various health complications. One of the key treatments for managing SCD is DROXIA (hydroxyurea), a medication that has been widely used to reduce the frequency of painful crises and other complications associated with the disease.

Market Size and Growth Projections

The global market for SCD treatments, including DROXIA, is experiencing significant growth. According to recent reports, the SCD treatment market is expected to expand from $2.40 billion in 2023 to $12.38 billion by 2032, reflecting a compound annual growth rate (CAGR) of 20.00% during the forecast period of 2024-2032[1].

Key Market Drivers

Increased Awareness and Advocacy

Increased awareness and advocacy for SCD have led to improved diagnosis and treatment options. This heightened awareness drives demand for effective treatments like DROXIA[1].

Investment in Research and Development

Growing investment in research and development for innovative therapies, including gene editing and novel drugs, is a significant driver. Emerging technologies like CRISPR are showing promise in treating SCD at the genetic level[1].

Supportive Government Policies

Supportive government policies and initiatives promoting awareness and funding for SCD research and patient care also contribute to market growth[1].

Market Segmentation and Dominant Players

Drug Type Segmentation

The SCD treatment market is segmented by drug type, with hydroxyurea (DROXIA) being a dominant segment. In 2021, the hydroxyurea segment dominated the global SCD treatment market due to its therapeutic benefits and multiple mechanisms of action[4].

Regional Dominance

North America accounts for a significant portion of the global SCD market, driven by advanced healthcare infrastructure, significant research funding, and the presence of major pharmaceutical companies focused on SCD treatments[1].

Financial Performance of Key Players

Revenue Growth

Companies involved in SCD treatments are seeing revenue growth driven by the expansion of their core businesses. For example, the B2B2C segment of companies like DarioHealth has shown significant growth, although this is more related to chronic care management rather than SCD specifically[2][5].

Operating Expenses and Profitability

While revenue is increasing, companies are also focusing on reducing operating expenses to achieve profitability. DarioHealth, for instance, expects a 38% reduction in total operating expenses between Q1 2024 and Q1 2025, which will contribute to achieving cash flow breakeven by the end of 2025[2].

Challenges in the Market

High Costs of New Treatments

The high costs associated with new treatments, particularly gene therapies, can limit accessibility for patients and healthcare systems. This is a significant challenge for the widespread adoption of innovative SCD treatments[1].

Limited Healthcare Infrastructure

In low-income regions, limited healthcare infrastructure hampers the adoption of effective treatments. This variability in healthcare policies and funding across regions complicates access to care and treatment options for patients with SCD[1].

Opportunities for Growth

Expanding Clinical Trials

Expanding clinical trials and research initiatives focused on gene therapies and new medications open pathways for innovative treatment options. This includes the potential use of CRISPR technology to correct the genetic mutation causing SCD[1].

Increasing Demand for SCD Drugs

The rise in demand for SCD drugs, driven by increasing prevalence and unmet medical needs, contributes to market growth. The adakveo segment, for example, is projected to exhibit the fastest market growth due to its effectiveness in treating vaso-occlusive crises (VOC) associated with SCD[4].

Regional Growth Prospects

North America

North America is expected to witness the highest growth in terms of revenue due to the rise in prevalence of SCD, increased healthcare expenditure, and the strong presence of key players[1][4].

Asia-Pacific

The Asia-Pacific region is anticipated to witness notable growth due to unmet medical demands and the rise in R&D pipeline products for SCD during the forecast period[4].

Impact of Emerging Technologies

Gene-Editing Technologies

Gene-editing technologies like CRISPR are promising for treating SCD at the genetic level. These technologies could offer long-term solutions by correcting the hemoglobin mutation, although their high cost and complexity are current barriers[1].

"Gene-editing technology, particularly CRISPR, has shown promise in trials to correct the hemoglobin mutation at the genetic level, potentially offering a long-term solution." - Introspective Market Research[1]

Key Players in the Market

Top companies such as Global Blood Therapeutics, Inc., Novartis AG, Bristol Myers Squibb Company, and Emmaus Life Sciences hold a high market position in the SCD treatment market. These companies are driving innovation and growth through their R&D activities and product offerings[4].

Conclusion

The market for SCD treatments, including DROXIA, is poised for significant growth driven by increased awareness, investment in R&D, and supportive government policies. While challenges such as high treatment costs and limited healthcare infrastructure exist, opportunities in expanding clinical trials and increasing demand for SCD drugs offer a promising future.

Key Takeaways

  • The SCD treatment market is expected to grow from $2.40 billion in 2023 to $12.38 billion by 2032.
  • Hydroxyurea (DROXIA) is a dominant segment in the SCD treatment market.
  • North America leads the global SCD market due to advanced healthcare infrastructure and significant research funding.
  • Emerging technologies like CRISPR offer potential long-term solutions for SCD.
  • High costs and limited healthcare infrastructure are significant challenges.
  • Expanding clinical trials and increasing demand for SCD drugs drive market growth.

FAQs

What is the expected growth rate of the SCD treatment market?

The SCD treatment market is expected to grow at a CAGR of 20.00% from 2024 to 2032[1].

Which region dominates the global SCD market?

North America dominates the global SCD market, accounting for approximately 35.19% of global demand in 2023[1].

What are the key challenges in the SCD treatment market?

Key challenges include high costs associated with new treatments, limited healthcare infrastructure in low-income regions, and variability in healthcare policies and funding[1].

How does gene-editing technology like CRISPR impact SCD treatment?

Gene-editing technology like CRISPR has shown promise in correcting the hemoglobin mutation at the genetic level, potentially offering a long-term solution for SCD[1].

Which companies are leading in the SCD treatment market?

Top companies include Global Blood Therapeutics, Inc., Novartis AG, Bristol Myers Squibb Company, and Emmaus Life Sciences[4].

Sources

  1. Introspective Market Research, "Sickle Cell Disease Market Reach USD 12.38 Bn by 2032, Set to Grow Remarkable CAGR of 20.00% from 2024-2032," GlobeNewswire, November 7, 2024.
  2. DarioHealth, "DarioHealth Reports Third Quarter 2024 Financial and Operating Results," PR Newswire, November 7, 2024.
  3. Morgan Stanley Research, "Scaling Up the Impact of Obesity Drugs," Morgan Stanley, May 7, 2024.
  4. Allied Market Research, "Sickle Cell Disease Treatment Market Size, Share | Forecast - 2031," Allied Market Research.
  5. DarioHealth, "DarioHealth Reports Fourth Quarter and Full-Year 2023 Financial and Operating Results," DarioHealth Investor Room, March 28, 2024.

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