You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

AZATHIOPRINE SODIUM - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for azathioprine sodium and what is the scope of freedom to operate?

Azathioprine sodium is the generic ingredient in two branded drugs marketed by Hikma and Casper Pharma Llc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for AZATHIOPRINE SODIUM
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 9
Clinical Trials: 16
Patent Applications: 3
What excipients (inactive ingredients) are in AZATHIOPRINE SODIUM?AZATHIOPRINE SODIUM excipients list
DailyMed Link:AZATHIOPRINE SODIUM at DailyMed
Recent Clinical Trials for AZATHIOPRINE SODIUM

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

SponsorPhase
The University of Hong KongPhase 2
AstraZenecaPhase 3
Jiangsu Renocell Biotech CompanyPhase 2

See all AZATHIOPRINE SODIUM clinical trials

Pharmacology for AZATHIOPRINE SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for AZATHIOPRINE SODIUM

US Patents and Regulatory Information for AZATHIOPRINE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma AZATHIOPRINE SODIUM azathioprine sodium INJECTABLE;INJECTION 074419-001 Mar 31, 1995 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Casper Pharma Llc IMURAN azathioprine sodium INJECTABLE;INJECTION 017391-001 Approved Prior to Jan 1, 1982 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

AZATHIOPRINE SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Azathioprine Sodium

Introduction

Azathioprine sodium, a widely used immunosuppressant and anti-inflammatory drug, has been a cornerstone in the treatment of various autoimmune diseases and organ transplant rejection. This article delves into the market dynamics and financial trajectory of azathioprine sodium, highlighting its current status, growth prospects, and key factors influencing its market.

Historical Context and Development

Azathioprine was first synthesized in 1956 by Gertrude Elion, William Lange, and George Hitchings, and it received FDA approval on March 20, 1968. Since then, it has been used to treat a range of conditions including rheumatoid arthritis, inflammatory bowel disease, and to prevent renal transplant rejection[2][4].

Market Size and Growth Projections

The azathioprine API market has experienced significant growth in recent years and is expected to continue this trend from 2023 to 2031. The market is segmented by type (purity ≥ 99%, purity ≥ 99.5%), application (tablets, other), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). Projections indicate robust growth rates over the forecast period, driven by increasing demand for immunosuppressive and anti-inflammatory treatments[1].

Key Drivers of Market Growth

Several factors are driving the growth of the azathioprine sodium market:

Increasing Prevalence of Autoimmune Diseases

The rising incidence of autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis is a significant driver. Azathioprine is often used as a first-line or adjunct therapy for these conditions, contributing to its growing demand[4].

Expanding Use in Organ Transplantation

The drug's role in preventing organ transplant rejection continues to be crucial, and advancements in transplantation procedures are likely to increase its usage[2].

Cost-Effectiveness

Studies have shown that combination therapy with azathioprine and other drugs, such as infliximab, can be cost-effective for treating drug-refractory conditions like Crohn's disease. This cost-effectiveness enhances its market appeal[3].

Market Segmentation

The azathioprine API market is segmented into several key categories:

By Type

  • Purity ≥ 99%: This segment is expected to see steady growth due to the high demand for pure API in pharmaceutical formulations.
  • Purity ≥ 99.5%: This segment is anticipated to grow rapidly as it meets the stringent quality standards required for critical applications[1].

By Application

  • Tablets: The most common form of azathioprine administration, tablets are expected to dominate the market.
  • Other: This includes intravenous formulations and other specialized applications, which are also growing in importance[1].

By Geography

  • North America: A significant market due to the high prevalence of autoimmune diseases and advanced healthcare infrastructure.
  • Europe: Another major market with a strong focus on research and development.
  • Asia-Pacific: Expected to show rapid growth due to increasing healthcare spending and a large patient population.
  • South America and Middle-East and Africa: These regions are also seeing growth, driven by improving healthcare access and increasing awareness of autoimmune diseases[1].

Key Players and Market Competition

The market for azathioprine API is competitive, with several key players:

  • Index Pharmaceutical
  • Rakshit Pharmaceuticals
  • Fermion
  • Aarti Industries
  • Atom Pharma
  • Aspen API
  • Cheng Yi Pharmaceutical
  • Dongdong Pharmaceutical
  • Yabang Pharmaceutical

These companies are profiled in the market report, which includes details on their market entry year and various market-related factors[1].

Financial Trajectory

The financial trajectory of the azathioprine API market is promising, with projections indicating significant revenue growth from 2023 to 2031. The market size is measured in USD million, and the report provides a detailed examination of revenue across different segments.

Revenue Projections

The market is expected to see substantial revenue growth, driven by the increasing demand for azathioprine in various therapeutic applications. The report provides a comprehensive assessment of market dynamics, including drivers, restraints, opportunities, and challenges, which collectively impact the financial performance of the market[1].

Cost-Effectiveness and Economic Impact

Combination therapies involving azathioprine have been shown to be cost-effective, which enhances their economic viability. For instance, a study on the combination of infliximab and azathioprine for drug-refractory Crohn's disease found that this approach was cost-effective compared to infliximab monotherapy[3].

Challenges and Restraints

Despite the positive growth prospects, the market faces several challenges:

Side Effects and Safety Concerns

Azathioprine is associated with several side effects, including bone marrow suppression, nausea, vomiting, and an increased risk of certain cancers. These safety concerns can impact market growth and require careful management[4].

Regulatory Changes

Changes in regulatory requirements, such as the FDA's updated labeling to inform users about the risk of hepatosplenic T-cell lymphoma, can influence market dynamics[4].

Future Outlook

The future outlook for the azathioprine API market is optimistic, driven by the increasing demand for immunosuppressive and anti-inflammatory treatments. Here are some key points to consider:

Growing Demand for Immunotherapies

The rising incidence of autoimmune diseases and the need for effective immunosuppressive therapies will continue to drive the demand for azathioprine.

Advancements in Pharmaceutical Technology

Improvements in pharmaceutical technology and manufacturing processes are expected to enhance the purity and efficacy of azathioprine API, further boosting market growth.

Expanding Geographical Reach

The market is expected to expand in emerging regions, driven by improving healthcare infrastructure and increasing awareness of autoimmune diseases.

"The Azathioprine API Market has undergone swift and considerable growth in recent times, and projections affirm that this notable expansion will endure from 2023 to 2031"[1].

Key Takeaways

  • The azathioprine API market is expected to see robust growth from 2023 to 2031.
  • Increasing prevalence of autoimmune diseases and expanding use in organ transplantation are key drivers.
  • The market is segmented by type, application, and geography.
  • Cost-effectiveness of combination therapies is a significant factor.
  • Safety concerns and regulatory changes are challenges that need to be addressed.
  • The future outlook is optimistic, driven by growing demand and advancements in pharmaceutical technology.

FAQs

What are the primary uses of azathioprine sodium?

Azathioprine sodium is used to treat inflammatory conditions like rheumatoid arthritis and as an immunosuppressant in the prevention of renal transplant rejection. It is also used in the management of autoimmune diseases such as Crohn's disease and ulcerative colitis[2][4].

What are the common side effects of azathioprine?

Common side effects include bone marrow suppression, nausea, vomiting, and an increased risk of certain cancers. Other side effects can include dizziness, diarrhea, fatigue, and rashes[4].

Is azathioprine cost-effective in combination therapies?

Yes, combination therapy with azathioprine and other drugs, such as infliximab, has been shown to be cost-effective for treating drug-refractory conditions like Crohn's disease[3].

Which regions are expected to drive the growth of the azathioprine API market?

North America, Europe, and Asia-Pacific are expected to be significant markets, with the Asia-Pacific region showing rapid growth due to increasing healthcare spending and a large patient population[1].

What are the key challenges facing the azathioprine API market?

The market faces challenges such as side effects and safety concerns, regulatory changes, and the need for careful management of these factors to ensure sustained growth[4].

Sources

  1. Market Research Intellect, "Global Azathioprine API Market Size, Scope And Forecast Report".
  2. DrugBank Online, "Azathioprine sodium".
  3. PubMed, "Economic impact of combination therapy with infliximab plus azathioprine for drug-refractory Crohn's disease".
  4. Wikipedia, "Azathioprine".

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.