AZATHIOPRINE Drug Patent Profile

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

Azathioprine is a drug marketed by Alkem Labs Ltd, Amneal, Rising, Zydus Pharms Usa, and Hikma. and is included in five NDAs.

The generic ingredient in AZATHIOPRINE is azathioprine sodium. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azathioprine sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Azathioprine

A generic version of AZATHIOPRINE was approved as azathioprine sodium by HIKMA on March 31^st, 1995.

Summary for AZATHIOPRINE

US Patents:	0
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	357
Patent Applications:	4,391
Drug Prices:	Drug price information for AZATHIOPRINE
DailyMed Link:	AZATHIOPRINE at DailyMed

See drug prices for AZATHIOPRINE

See drug sales revenues for AZATHIOPRINE

Recent Clinical Trials for AZATHIOPRINE

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

Sponsor	Phase
NovelMed Therapeutics	PHASE2
University Hospital Schleswig-Holstein	PHASE4
First Affiliated Hospital of Wenzhou Medical University	PHASE3

See all AZATHIOPRINE clinical trials

Pharmacology for AZATHIOPRINE

Drug Class	Purine Antimetabolite
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for AZATHIOPRINE

Antimetabolites

Antimetabolites, Antineoplastic

Antirheumatic Agents

Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for AZATHIOPRINE

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for AZATHIOPRINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	AZATHIOPRINE	azathioprine	TABLET;ORAL	208687-001	Mar 27, 2020	AB	RX	No	No
Amneal	AZATHIOPRINE	azathioprine	TABLET;ORAL	074069-003	Nov 2, 2021	AB	RX	No	No
Alkem Labs Ltd	AZATHIOPRINE	azathioprine	TABLET;ORAL	208687-004	Mar 27, 2020	AB	RX	No	No
Zydus Pharms Usa	AZATHIOPRINE	azathioprine	TABLET;ORAL	077621-004	Sep 5, 2008	AB	RX	No	No
Rising	AZATHIOPRINE	azathioprine	TABLET;ORAL	075568-001	Dec 13, 1999	AB	RX	No	No

EU/EMA Drug Approvals for AZATHIOPRINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Nova Laboratories Ireland Limited	Jayempi	azathioprine	EMEA/H/C/005055Jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. Azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression).Jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response.Jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – DMARDs)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidBehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm IgG antibodieschronic refractory idiopathic thrombocytopenic purpuraJayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (IBD) (Crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice.It is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3Jayempi is indicated for the treatment of generalised myasthenia gravis. Depending on the severity of the disease, Jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.	Authorised	no	no	no	2021-06-21

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Azathioprine

Last updated: July 27, 2025

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Introduction

Azathioprine, a purine synthesis inhibitor, is a cornerstone immunosuppressant widely used for autoimmune diseases and organ transplant rejection prophylaxis. Since its synthesis in the 1960s, azathioprine has maintained relevance, evolving within a complex pharmaceutical landscape characterized by changing regulatory environments, emerging therapies, and market forces. This article analyzes the current market dynamics and forecasts the financial trajectory of azathioprine, providing business professionals with comprehensive insights into its commercialization, competitive positioning, and future growth prospects.

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Historical Context and Therapeutic Profile

Initially developed as an anti-cancer agent, azathioprine’s immunosuppressant properties emerged when researchers observed its efficacy in autoimmune conditions such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis. Its most significant application remains in solid organ transplantation (kidney, liver, heart) to prevent graft rejection, where it is often part of combination therapy with corticosteroids and calcineurin inhibitors [1].

Despite its age, azathioprine's efficacy, safety profile, and cost-effectiveness have sustained its clinical relevance. Its mechanism involves inhibiting purine nucleotide synthesis, thereby impairing DNA replication in rapidly dividing cells, particularly immune cells [2].

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Market Dynamics Influencing Azathioprine

1. Competitive Landscape and Evolving Therapeutics

The global immunosuppressant market is increasingly competitive, with biologics and targeted therapies gradually supplanting older agents like azathioprine. For instance, drugs such as mycophenolate mofetil, tacrolimus, and biologic agents (e.g., infliximab, adalimumab) have gained approval for various autoimmune indications, offering potentially improved safety and efficacy profiles [3].

However, azathioprine’s low cost, extensive clinical experience, and generic availability sustain its usage, especially in resource-constrained settings. Its role remains prominent in developing countries and in contexts where newer, expensive biologics are either unavailable or economically unfeasible.

2. Regulatory Environment and Patent Status

Azathioprine’s patent expired decades ago, classifying it as a generic drug. This has facilitated widespread manufacturing, lowering prices, and enabling broad access. Nonetheless, regulatory considerations, such as pharmacovigilance requirements and evolving approval standards, influence its market presence. Strict manufacturing regulations, including immunogenicity monitoring, remain critical, especially in markets with stringent regulatory agencies like the FDA and EMA [4].

3. Patent Challenges and Formulation Innovations

Though no recent patents restrict azathioprine’s use, companies have explored formulations to improve bioavailability and patient compliance, such as extended-release variants. These innovations may provide incremental competitive advantages, though their market impact remains limited due to the drug’s existing long-standing generic status.

4. Pricing and Reimbursement Dynamics

Cost remains a pivotal factor. Generic azathioprine’s affordability makes it a preferred agent in many low- and middle-income countries. Reimbursement policies significantly influence prescribing behaviors; in jurisdictions with favorable reimbursement, azathioprine maintains a vital position, whereas in high-income markets, physicians may opt for newer agents based on perceived safety profiles.

5. Patent Litigation and Generic Competition

Patent disputes related to manufacturing processes or formulations are rare, owing to the drug's age and patent expiry. The emergence of multiple manufacturers has resulted in fierce price competition, further suppressing costs [5].

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Financial Trajectory of Azathioprine

1. Current Market Size and Revenue

The global immunosuppressant market, valued at approximately $4.2 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 5% through 2030, driven by expanding transplant procedures and autoimmune disease prevalence [6].

Azathioprine, accounting for a significant segment, contributes roughly $300 million annually, primarily derived from established markets in North America, Europe, and Asia. Its dominant revenue source stems from generic sales, with revenues relatively stable due to low manufacturing costs.

2. Growth Drivers

• Expanding Organ Transplantation Procedures: The number of transplants continues to increase, especially in emerging economies, bolstering azathioprine demand.
• Autoimmune Disease Prevalence: Rising incidence of autoimmune conditions, particularly in aging populations, sustains therapeutic use.
• Cost-Effectiveness Preference: Healthcare systems favor affordable drugs, keeping azathioprine relevant in budget-sensitive environments.
• Generic Market Expansion: Entry of multiple manufacturers maintains competitive prices and steady volume sales.

3. Market Limitations and Challenges

• Emergence of New Therapies: Increased adoption of biologics and targeted immunosuppressants limit azathioprine’s growth potential.
• Safety Concerns: Risks of myelosuppression, hepatotoxicity, and increased cancer incidence have prompted clinicians to consider alternatives.
• Regulatory Revisions: Stringent safety monitoring requirements may limit supply or increase manufacturing costs.

4. Future Outlook and Revenue Projections

Forecasts anticipate a modest decline or plateau in azathioprine sales in high-income markets, mirroring global trends toward newer agents with improved safety profiles. In contrast, growth is probable in developing regions due to expanding healthcare coverage and affordability considerations.

By 2030, azathioprine’s global revenues are projected to stabilize around $250 million to $300 million annually. Meanwhile, niche applications, such as in veterinary medicine and specific autoimmune indications, may generate incremental upside.

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Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Focus on cost-effective manufacturing, quality assurance, and potential formulation enhancements to prolong market relevance.
• Investors: Recognize azathioprine’s resilience in expanding markets but remain cautious about long-term growth amid emerging therapies.
• Healthcare Providers: Weigh cost efficiencies against safety profiles, emphasizing monitoring protocols essential for safe use.

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Regulatory and Market Entry Opportunities

Emerging markets present underserved populations with limited access to newer immunosuppressants. Strategic partnerships and local manufacturing can enable companies to capture share, leveraging azathioprine’s low-cost advantage. Furthermore, ongoing quality improvements and evidence-based positioning may reinforce its role in comprehensive immunosuppressive regimens.

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Key Takeaways

• Azathioprine remains a significant, cost-effective immunosuppressant, especially in emerging markets and resource-limited settings.
• Market dynamics are shifting due to competition from biologics and targeted agents, constraining revenue growth in developed markets.
• The global market is projected to decline modestly but maintain steady revenues, estimated at $250–300 million annually by 2030.
• Competitive advantages hinge on manufacturing efficiency, regulatory compliance, and strategic positioning within healthcare systems emphasizing affordability.
• Ongoing safety monitoring and formulation innovations will be vital for sustaining relevance amid evolving therapeutic landscapes.

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FAQs

1. Will azathioprine continue to be used despite newer immunosuppressants?
Yes. Its affordability, extensive clinical experience, and widespread generics ensure continued use, particularly in resource-constrained regions. However, its role may diminish in high-income countries favoring newer agents with better safety profiles.

2. How do safety concerns impact azathioprine’s market?
Safety issues, including increased risk of infections and malignancies, prompt clinicians to consider alternatives. Regulatory mandates for rigorous monitoring may also influence prescribing patterns and manufacturing costs.

3. Are there ongoing developments to enhance azathioprine?
Formulation improvements, such as extended-release versions, are under exploration, aiming to improve compliance and reduce side effects. However, these have limited impact compared to emerging therapies.

4. What is azathioprine’s outlook in emerging markets?
Strong. Its low cost and established efficacy make it a mainstay, with sales growth driven by expanding healthcare infrastructure and transplantation programs.

5. How might biosimilars or generics influence azathioprine’s market?
Multiple generic manufacturers sustain price competition, maintaining affordability and widespread access. Biosimilar development is less relevant due to azathioprine’s small-molecule nature, but ongoing generics impact pricing significantly.

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References:

[1] Rothera, J. (2013). Immunosuppressant drugs in transplantation. Journal of Transplant Immunology.
[2] Choi, H. et al. (2018). Pharmacology of Azathioprine. Clinical Pharmacology.
[3] Hart, A. et al. (2021). Global Trends in Immunosuppressive Therapies. Transplantation Review.
[4] FDA. (2020). Guidelines on Immunosuppressive Agents. U.S. Food and Drug Administration.
[5] MarketWatch. (2022). Generic Drug Market Trends.
[6] Grand View Research. (2023). Immunosuppressant Market Size and Forecast.