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Last Updated: December 22, 2024

PURINETHOL Drug Patent Profile


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When do Purinethol patents expire, and when can generic versions of Purinethol launch?

Purinethol is a drug marketed by Stason Pharms and is included in one NDA.

The generic ingredient in PURINETHOL 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 Purinethol

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

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Summary for PURINETHOL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 171
Clinical Trials: 57
Patent Applications: 1,767
What excipients (inactive ingredients) are in PURINETHOL?PURINETHOL excipients list
DailyMed Link:PURINETHOL at DailyMed
Drug patent expirations by year for PURINETHOL
Recent Clinical Trials for PURINETHOL

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

SponsorPhase
City of Hope Medical CenterPhase 1
PfizerPhase 2
EsPhALL network I-BFM Study GroupPhase 3

See all PURINETHOL clinical trials

US Patents and Regulatory Information for PURINETHOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Stason Pharms PURINETHOL mercaptopurine TABLET;ORAL 009053-002 Approved Prior to Jan 1, 1982 AB RX 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

EU/EMA Drug Approvals for PURINETHOL

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

PURINETHOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Purinethol (Mercaptopurine)

Introduction to Purinethol (Mercaptopurine)

Purinethol, also known as mercaptopurine or 6-MP, is a medication widely used in the treatment of various medical conditions, including cancer and autoimmune diseases. It is particularly effective in treating acute lymphocytic leukemia (ALL), acute promyelocytic leukemia (APL), Crohn's disease, and ulcerative colitis[4].

Market Size and Growth Projections

The global market for mercaptopurine drugs has been experiencing significant growth and is expected to continue this trend. As of 2023, the market was estimated to be worth US$ 418 million. It is forecasted to reach a readjusted size of US$ 627.3 million by 2030, with a Compound Annual Growth Rate (CAGR) of 6.3% during the forecast period of 2024-2030[1].

Market Segmentation

The mercaptopurine drugs market is segmented based on several factors:

By Type

  • The market includes different formulations such as mercaptopurine tablets and injections. Additionally, it is available in various concentrations, including 20mg/ml and 5mg/ml[1][3].

By Application

  • The primary applications of mercaptopurine include the treatment of acute lymphocytic leukemia (ALL), Crohn's disease, and other conditions. Its use in treating autoimmune diseases like ulcerative colitis is also significant[3][4].

By Region

  • The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region has its own set of market dynamics influenced by local healthcare policies, patient demographics, and economic factors[3].

Key Drivers of Market Growth

Several factors are driving the growth of the mercaptopurine drugs market:

Increasing Prevalence of Target Diseases

  • The rising incidence of acute lymphocytic leukemia and autoimmune diseases such as Crohn's disease and ulcerative colitis is a significant driver. As the global population ages and lifestyle factors contribute to higher disease prevalence, the demand for effective treatments like mercaptopurine is expected to increase[3].

Advancements in Healthcare Infrastructure

  • Improvements in healthcare infrastructure, especially in developing regions, are enhancing access to advanced treatments. This expansion of healthcare services is likely to boost the market for mercaptopurine drugs[3].

Pharmacogenomics and Personalized Medicine

  • The integration of pharmacogenomics, which involves tailoring drug treatments to individual genetic profiles, is becoming more prevalent. This could lead to more effective use of mercaptopurine and other drugs, driving market growth[5].

Market Restraints and Challenges

Despite the positive growth projections, there are several challenges that the mercaptopurine drugs market faces:

Side Effects and Safety Concerns

  • Mercaptopurine has been associated with significant side effects, including a high risk of fetal abnormalities and miscarriage when used during pregnancy. These safety concerns can limit its use in certain patient populations[4].

Regulatory Hurdles

  • The strict regulatory environment, particularly the FDA's categorization of mercaptopurine as a category D drug during pregnancy, can impact market growth. Compliance with regulatory requirements and ensuring patient safety are ongoing challenges[4].

Financial Performance of Key Players

Companies involved in the production and distribution of mercaptopurine drugs are experiencing varied financial performances:

Revenue and Market Share

  • Nova Laboratories is one of the main players in the mercaptopurine drugs market. The financial performance of such companies is closely tied to the overall market growth and their ability to navigate regulatory and competitive landscapes[1].

Research and Development Expenses

  • Companies like Revolution Medicines, although not specifically focused on mercaptopurine, illustrate the high research and development expenses associated with bringing new drugs to market. For instance, Revolution Medicines reported R&D expenses of $151.8 million for the quarter ended September 30, 2024, highlighting the significant investment required in the pharmaceutical sector[2].

Cash Position and Funding

  • The cash position of pharmaceutical companies is crucial for sustaining operations and funding research. For example, Revolution Medicines had $1.55 billion in cash, cash equivalents, and marketable securities as of September 30, 2024, which is expected to fund their operations into 2027[2].

Net Loss and Financial Guidance

  • Many pharmaceutical companies, including those involved in the mercaptopurine market, often report net losses due to high R&D expenses and other operational costs. Revolution Medicines, for instance, reported a net loss of $156.3 million for the quarter ended September 30, 2024, and projected a full-year 2024 GAAP net loss between $560 million and $600 million[2].

Market Opportunities and Challenges

Expanding into New Markets

  • There is a significant opportunity for mercaptopurine drugs in emerging markets where access to advanced treatments is increasing. However, this expansion also comes with challenges such as regulatory compliance and competition from local manufacturers[3].

Generic Competition

  • The mercaptopurine market faces competition from generic versions of the drug, which can impact the market share of branded products. Managing this competition while maintaining profitability is a key challenge for manufacturers[1].

Conclusion

The mercaptopurine drugs market, led by products like Purinethol, is poised for significant growth driven by increasing disease prevalence, advancements in healthcare infrastructure, and the integration of pharmacogenomics. However, the market must navigate challenges such as side effects, regulatory hurdles, and generic competition.

Key Takeaways

  • The global mercaptopurine drugs market is projected to reach US$ 627.3 million by 2030.
  • The market is driven by the increasing prevalence of target diseases and advancements in healthcare infrastructure.
  • Key challenges include side effects, regulatory concerns, and generic competition.
  • Companies like Nova Laboratories play a significant role in the market, with financial performances influenced by R&D expenses and regulatory environments.

FAQs

What is the forecasted market size for mercaptopurine drugs by 2030?

The forecasted market size for mercaptopurine drugs by 2030 is US$ 627.3 million[1].

What are the primary applications of mercaptopurine?

Mercaptopurine is primarily used to treat acute lymphocytic leukemia (ALL), acute promyelocytic leukemia (APL), Crohn's disease, and ulcerative colitis[4].

Which companies are key players in the mercaptopurine drugs market?

Nova Laboratories is one of the main players in the mercaptopurine drugs market[1].

What are the significant side effects associated with mercaptopurine?

Mercaptopurine is associated with a high risk of fetal abnormalities and miscarriage when used during pregnancy[4].

How is the market segmented?

The market is segmented by type (e.g., tablets, injections), application (e.g., ALL, Crohn's disease), and geographical region (e.g., North America, Europe)[1][3].

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