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Last Updated: December 22, 2024

MERCAPTOPURINE Drug Patent Profile


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

Mercaptopurine is a drug marketed by Dr Reddys Labs Sa, Hikma, and Mylan. and is included in three NDAs.

The generic ingredient in MERCAPTOPURINE 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 Mercaptopurine

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

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

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Recent Clinical Trials for MERCAPTOPURINE

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SponsorPhase
Pediatric Oncology Experimental Therapeutics Investigators' ConsortiumPhase 1/Phase 2
Lucile Packard Children's Hospital FoundationPhase 1/Phase 2
Stanford UniversityPhase 1/Phase 2

See all MERCAPTOPURINE clinical trials

Pharmacology for MERCAPTOPURINE
Anatomical Therapeutic Chemical (ATC) Classes for MERCAPTOPURINE

US Patents and Regulatory Information for MERCAPTOPURINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa MERCAPTOPURINE mercaptopurine TABLET;ORAL 040461-001 Feb 11, 2004 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma MERCAPTOPURINE mercaptopurine TABLET;ORAL 040528-001 Feb 13, 2004 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan MERCAPTOPURINE mercaptopurine TABLET;ORAL 040594-001 Jul 1, 2005 AB 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

EU/EMA Drug Approvals for MERCAPTOPURINE

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

MERCAPTOPURINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mercaptopurine

Introduction to Mercaptopurine

Mercaptopurine, a purine analog, is a crucial medication used in the treatment of various medical conditions, including Acute Lymphoblastic Leukemia (ALL), Crohn's Disease, and Ulcerative Colitis. The market for mercaptopurine has been experiencing significant growth, driven by increasing demand and advancements in healthcare.

Market Size and Growth Projections

The global mercaptopurine market has witnessed substantial growth in recent years and is expected to continue this upward trajectory. Here are some key projections:

  • Current Market Size: The global mercaptopurine market was valued at approximately $418 million in 2023[4].
  • Forecasted Growth: The market is anticipated to reach $627.3 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.3% during the forecast period from 2024 to 2030[4].
  • Segmentation: The market is segmented by type (tablets, oral suspension, and injections) and application (ALL, Crohn's Disease, Ulcerative Colitis, and others), with geographical regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][2].

Market Dynamics

Drivers

  • Increasing Prevalence of Target Diseases: The rising incidence of ALL, Crohn's Disease, and Ulcerative Colitis is a significant driver for the mercaptopurine market. As these diseases become more prevalent, the demand for effective treatments like mercaptopurine increases[1][2].
  • Advancements in Healthcare: Improvements in healthcare infrastructure and access to advanced treatments are boosting the market. Better diagnostic techniques and increased awareness about these diseases also contribute to the growth[2].
  • Government Initiatives and Funding: Government support and funding for research and development in the pharmaceutical sector are crucial drivers. These initiatives help in the development of new formulations and delivery methods, such as oral solutions and injections[1].

Restraints

  • Side Effects and Toxicity: Mercaptopurine is known to have significant side effects, including hepatotoxicity and myelosuppression. These adverse effects can limit its use and impact market growth[5].
  • Generic Competition: The presence of generic versions of mercaptopurine can reduce the market share of branded products, affecting the overall revenue of key players[2].

Opportunities

  • Emerging Markets: The Asia-Pacific region and other emerging markets offer significant opportunities for growth due to their large patient populations and improving healthcare systems[1][2].
  • New Formulations and Delivery Methods: The development of new formulations, such as oral solutions, can enhance patient compliance and open up new market segments[1].

Challenges

  • Regulatory Hurdles: Strict regulatory requirements and the need for extensive clinical trials can pose challenges for new product launches and market expansion[2].
  • Economic Factors: Economic fluctuations and changes in healthcare policies can impact the affordability and accessibility of mercaptopurine, affecting market dynamics[1].

Competitive Landscape

The mercaptopurine market is highly competitive, with several key players dominating the landscape:

  • Major Players: Companies such as Pfizer Inc., Teva Pharmaceutical Industries Ltd., Aspen Pharmacare Holdings Limited, and Mylan NV are prominent in the market. These companies are involved in various strategies including new product launches, collaborations, and mergers and acquisitions to maintain their market position[1][2].
  • Emerging Players: New entrants like Nova Laboratories are also making significant contributions, particularly in emerging markets[4].

Financial Trajectory

The financial trajectory of the mercaptopurine market is positive, with several indicators pointing to sustained growth:

  • Revenue Forecast: The market is expected to grow from $418 million in 2023 to $627.3 million by 2030, indicating a robust financial outlook[4].
  • Segment Performance: The oral solution segment is expected to grow significantly due to its ease of administration and better patient compliance. Geographically, the Asia-Pacific region is anticipated to be a high-growth market[1][3].

Regional Analysis

The mercaptopurine market is diverse and spread across various geographical regions:

  • North America and Europe: These regions are mature markets with established healthcare systems and high demand for mercaptopurine. However, the growth rate in these regions is expected to be moderate compared to emerging markets[1][2].
  • Asia-Pacific: This region is expected to be a high-growth market due to its large patient population, improving healthcare infrastructure, and increasing awareness about the diseases treated by mercaptopurine[1][2].

Consumer Behavior and Economic Impact

Consumer behavior plays a crucial role in the mercaptopurine market:

  • Patient Compliance: The development of oral solutions and other user-friendly formulations has improved patient compliance, contributing to market growth[1].
  • Economic Impact: The cost of mercaptopurine can be significant, especially for long-term treatments. However, the overall economic impact is positive as effective treatment reduces the financial burden of managing chronic diseases in the long run[5].

Key Takeaways

  • Growing Market Size: The mercaptopurine market is expected to grow significantly, reaching $627.3 million by 2030.
  • Segmented Growth: The market is segmented by type and application, with oral solutions and the Asia-Pacific region showing high growth potential.
  • Competitive Landscape: Major players like Pfizer and Teva dominate the market, while emerging players are making significant contributions.
  • Financial Outlook: The financial trajectory is positive, driven by increasing demand and new product developments.

FAQs

Q: What is the current market size of the mercaptopurine market? A: The global mercaptopurine market was valued at approximately $418 million in 2023[4].

Q: What is the expected CAGR of the mercaptopurine market from 2024 to 2030? A: The market is anticipated to grow at a CAGR of 6.3% during the forecast period from 2024 to 2030[4].

Q: Which regions are expected to be high-growth markets for mercaptopurine? A: The Asia-Pacific region is expected to be a high-growth market due to its large patient population and improving healthcare infrastructure[1][2].

Q: What are the main types of mercaptopurine products available in the market? A: The main types include mercaptopurine tablets, oral suspension, and injections[1][2].

Q: Who are the major players in the mercaptopurine market? A: Major players include Pfizer Inc., Teva Pharmaceutical Industries Ltd., Aspen Pharmacare Holdings Limited, and Mylan NV[1][2].

Sources

  1. Market Research Intellect: Global Mercaptopurine Oral Solution Drugs Sales Market Size, Scope And Forecast Report[1].
  2. Market Research Intellect: Mercaptopurine Drugs Sales Market Size, Scope And Forecast Report[2].
  3. Dataintelo: Global Mercaptopurine Oral Solution Drugs Market[3].
  4. Valuates Reports: Mercaptopurine Market Report[4].
  5. PMC: Group-Based Trajectory Modeling of Healthcare Financial Charges[5].

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