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Last Updated: December 22, 2024

PURIXAN Drug Patent Profile


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When do Purixan patents expire, and what generic alternatives are available?

Purixan is a drug marketed by Nova Labs Ltd and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Purixan

A generic version of PURIXAN was approved as mercaptopurine by DR REDDYS LABS SA on February 11th, 2004.

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

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Recent Clinical Trials for PURIXAN

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SponsorPhase
National Cancer Institute (NCI)Phase 3
Massachusetts General HospitalPhase 1
Millennium Pharmaceuticals, Inc.Phase 1

See all PURIXAN clinical trials

Pharmacology for PURIXAN

US Patents and Regulatory Information for PURIXAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nova Labs Ltd PURIXAN mercaptopurine SUSPENSION;ORAL 205919-001 Apr 28, 2014 RX Yes Yes ⤷  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

EU/EMA Drug Approvals for PURIXAN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Nova Laboratories Ireland Limited Xaluprine (previously Mercaptopurine Nova Laboratories) mercaptopurine EMEA/H/C/002022
Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.
Authorised no no no 2012-03-09
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

PURIXAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Purixan

Introduction to Purixan

Purixan, an oral suspension form of 6-mercaptopurine (6-MP), is a crucial medication in the treatment of acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. Here, we delve into the market dynamics and financial trajectory of Purixan, highlighting key factors influencing its growth and challenges.

Market Size and Projections

The Purixan market is experiencing significant growth, driven by increasing demand for effective treatments for ALL. As of 2023, the market size was valued at USD 120 million and is projected to reach USD 220 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.1% from 2024 to 2031[1].

However, different reports provide varying estimates, with some sources suggesting a much larger market size. For instance, one report indicates the market size was valued at USD 200 billion in 2023 and is expected to reach USD 400 billion by 2031, growing at a CAGR of 10.41% during the forecast period[4].

Key Drivers of Market Growth

Several factors are driving the growth of the Purixan market:

Rising Prevalence of ALL

The increasing incidence of acute lymphoblastic leukemia, particularly in children, is a major driver. ALL is the most common malignancy in childhood, and Purixan's effectiveness in treating this condition has led to its widespread adoption[2].

Enhanced Awareness and Clinical Evidence

Growing awareness and clinical evidence supporting the efficacy of Purixan have significantly contributed to its market expansion. The medication's inclusion in multi-drug therapy regimens for ALL has been backed by extensive clinical trials and real-world data[1][5].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in developed regions like North America and Europe, have facilitated better access to advanced cancer therapies, including Purixan. This infrastructure includes advanced diagnostic facilities, specialized treatment centers, and robust reimbursement policies[4].

Personalized Medicine and R&D Investments

The growing emphasis on personalized medicine and significant investments by pharmaceutical companies in research and development are expected to further accelerate the market growth. New formulations and delivery systems, such as the oral suspension form of Purixan, offer improved patient compliance and treatment outcomes[1][3].

Market Segmentation

The Purixan market is segmented based on several criteria:

By Type

The market is categorized into oral vaccines, edible vaccine capsules, and transgenic plant-based vaccines, although Purixan specifically falls under the oral formulation category[1].

By Application

Key applications include disease prevention, immune system support, agricultural applications, and research. However, the primary application of Purixan is in the treatment of ALL[1].

By Geography

The market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America, particularly the United States, is a leading region due to high awareness of rare diseases and advanced healthcare infrastructure[1][4].

Challenges and Restraints

Despite the positive growth trajectory, several challenges affect the Purixan market:

Regulatory Challenges

Strict regulatory processes and approval requirements can delay market entry for new treatments or generics, impacting the overall market growth[4].

High Treatment Costs

The high cost of Purixan and related therapies can limit access for patients, especially in regions with limited healthcare resources and reimbursement policies[4].

Competition from Alternatives

The presence of alternative therapies and generics can lead to price competition, affecting the market share of Purixan. Patent expirations can also increase competition from generic manufacturers[4].

Side Effects and Patient Compliance

Potential side effects, such as myelosuppression, anemia, and other adverse reactions, can affect patient compliance and willingness to continue treatment. This can negatively impact the market demand[5].

Healthcare Infrastructure and Economic Factors

Inadequate healthcare facilities in certain regions and economic downturns can restrict access to necessary treatments and impact healthcare budgets, respectively[4].

Competitive Landscape

The Purixan market is characterized by a competitive landscape involving several key players:

  • Salix Pharmaceuticals
  • Mylan N.V.
  • Teva Pharmaceutical Industries Ltd.
  • HEC Pharm
  • Apotex Inc.
  • Sandoz (Novartis)
  • Fresenius Kabi AG
  • Amgen Inc.
  • Sun Pharmaceutical Industries Ltd.[4]

These companies are involved in various aspects of the market, including manufacturing, distribution, and research and development.

Financial Performance and Projections

The financial performance of the Purixan market is robust, with significant growth projected over the forecast period. Here are some key financial metrics:

  • Market Size (2023): USD 120 million to USD 200 billion (depending on the source)[1][4]
  • Projected Market Size (2031): USD 220 million to USD 400 billion[1][4]
  • CAGR: 8.1% to 10.41% from 2024 to 2031[1][4]

Key Takeaways

  • The Purixan market is driven by the rising prevalence of ALL and the increasing adoption of Purixan as an effective treatment.
  • Enhanced awareness, clinical evidence, and advancements in healthcare infrastructure are key growth drivers.
  • The market faces challenges such as regulatory hurdles, high treatment costs, competition from alternatives, and side effects affecting patient compliance.
  • The competitive landscape includes several major pharmaceutical companies.
  • Financial projections indicate significant growth over the forecast period.

FAQs

Q: What is the primary indication for Purixan? A: Purixan is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen[5].

Q: What are the common adverse reactions associated with Purixan? A: Common adverse reactions include myelosuppression, anemia, neutropenia, lymphopenia, thrombocytopenia, anorexia, nausea, vomiting, diarrhea, malaise, and rash[5].

Q: Which regions are expected to dominate the Purixan market? A: North America, particularly the United States, and Europe are expected to be leading regions due to high awareness of rare diseases and advanced healthcare infrastructure[4].

Q: What are the key factors affecting the growth of the Purixan market? A: Key factors include the rising prevalence of ALL, enhanced awareness and clinical evidence, advancements in healthcare infrastructure, and investments in research and development[1][3].

Q: Who are the major players in the Purixan market? A: Major players include Salix Pharmaceuticals, Mylan N.V., Teva Pharmaceutical Industries Ltd., HEC Pharm, Apotex Inc., Sandoz (Novartis), Fresenius Kabi AG, Amgen Inc., and Sun Pharmaceutical Industries Ltd.[4].

Cited Sources

  1. Market Research Intellect - Global Purixan Market Size and Forecast
  2. FDA - NDA 205919 Orig1s000 Medical Review
  3. Cognitive Market Research - Purixan Market Report 2024 (Global Edition)
  4. Verified Market Research - Purixan Market Trends, Growth, Size, & Forecast
  5. Purixan-US - Purixan® 6-mercaptopurine - oral suspension liquid - FDA Approved

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