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:	10
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	322
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
Henan Cancer Hospital	Phase 2
Tianjin Medical University Second Hospital	Phase 2
The Second Affiliated Hospital of Kunming Medical University	Phase 2

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/005055 Jayempi 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

AZATHIOPRINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Azathioprine

Introduction

Azathioprine, a widely used immunosuppressive drug, has been a cornerstone in the treatment of various autoimmune diseases and organ transplantation. Understanding the market dynamics and financial trajectory of azathioprine is crucial for stakeholders, including pharmaceutical companies, healthcare providers, and patients.

Market Size and Growth Projections

The azathioprine market is anticipated to experience significant growth over the forecast period from 2024 to 2031. The global market size is expected to expand at a remarkable compound annual growth rate (CAGR), driven by increasing demand and advancements in healthcare[1][4].

• Global Market Size: The azathioprine market is projected to grow substantially, with the global market size estimated to increase from its current value to a higher figure by 2031.
• CAGR: The market is expected to grow at a CAGR that indicates robust expansion, reflecting the drug's essential role in treating autoimmune diseases and its growing adoption[1][4].

Market Segmentation

The azathioprine market is segmented based on several key factors:

Type

• Dosage Forms: Azathioprine is available in various dosage forms, including 50mg and 100mg tablets. The market is segmented based on these types, with each having different market shares and growth prospects[1][4].

Application

• Hospital Pharmacies: A significant portion of azathioprine is dispensed through hospital pharmacies, particularly for patients undergoing organ transplants and those with severe autoimmune conditions.
• Retail Pharmacies: Retail pharmacies also play a crucial role, especially for patients with chronic conditions like rheumatoid arthritis.
• Online Pharmacies: The rise of online pharmacies has made azathioprine more accessible, contributing to market growth[1][4].

Geographical Regions

• North America: This region is a major market for azathioprine due to high healthcare spending and advanced medical infrastructure.
• Europe: Europe is another significant market, driven by a large patient base and strong healthcare systems.
• Asia-Pacific: This region is expected to show rapid growth due to increasing healthcare expenditure and a large population base[1][4].

Market Drivers

Several factors are driving the growth of the azathioprine market:

Increasing Prevalence of Autoimmune Diseases

• The rising incidence of autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and autoimmune hepatitis is a key driver. For instance, autoimmune hepatitis affects approximately 20-50 individuals per million worldwide, contributing to the demand for azathioprine[3].

Advancements in Biologics and Immunosuppressants

• The development of novel immunosuppressive drugs and biologics has enhanced treatment options, making azathioprine a preferred choice due to its efficacy and relatively lower cost compared to newer biologics[3].

Cost-Effectiveness

• Combination therapy with azathioprine and other drugs, such as infliximab, has been shown to be cost-effective for treating drug-refractory Crohn's disease, further boosting its market appeal[2].

Market Restraints

Despite the positive outlook, there are several challenges affecting the azathioprine market:

Side Effects and Safety Concerns

• Azathioprine is associated with side effects such as an increased risk of lymphoma in patients with inflammatory bowel disease, which can impact its adoption[2].

High Cost of Treatment

• Although azathioprine is generally cheaper than biologics, the overall cost of treatment, especially when combined with other therapies, can be high, limiting access in some regions[3].

Financial Considerations

The cost of azathioprine can vary significantly based on several factors:

Insurance Coverage

• The cost with insurance is generally lower than without it, but it depends on the specific insurance plan, prior authorization requirements, and the pharmacy used[5].

Generic vs. Brand Name

• Azathioprine is available as generic and brand-name drugs (Imuran and Azasan). Generic versions are typically cheaper and considered as safe and effective as the brand-name counterparts[5].

Savings Programs and Coupons

• Various savings programs and coupons, such as Optum Perks, can help reduce the cost of azathioprine for patients[5].

Competitive Landscape

The azathioprine market is competitive, with several key players:

• Major Players: Companies like Novartis, Gilead Sciences, Pfizer, Merck & Co., and Bristol-Myers Squibb are significant players in the immunosuppressive drug market, including azathioprine[3].

Future Prospects

The future of the azathioprine market looks promising due to several factors:

Pipeline Drugs

• The development of novel immunosuppressive drugs with improved efficacy and safety profiles is expected to drive growth. For example, drugs like R0761 and LPN1010 are in various stages of clinical trials and show promising results[3].

Expanding Patient Base

• The growing global population and increasing environmental exposures are expected to increase the prevalence of autoimmune diseases, thereby expanding the patient base for azathioprine[3].

Key Takeaways

• Market Growth: The azathioprine market is expected to grow significantly from 2024 to 2031, driven by increasing demand and advancements in healthcare.
• Segmentation: The market is segmented by type, application, and geographical regions, each with its own growth prospects.
• Drivers: Increasing prevalence of autoimmune diseases, advancements in biologics, and cost-effectiveness are key drivers.
• Restraints: Side effects, safety concerns, and high treatment costs are significant restraints.
• Financial Considerations: The cost of azathioprine varies based on insurance coverage, generic vs. brand name, and savings programs.
• Competitive Landscape: The market is competitive with major players focusing on developing novel immunosuppressive drugs.

FAQs

What are the primary applications of azathioprine?

Azathioprine is primarily used to treat autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and autoimmune hepatitis, as well as to prevent rejection in organ transplantation.

How does the cost of azathioprine vary with insurance?

The cost of azathioprine with insurance is generally lower and depends on the specific insurance plan, prior authorization requirements, and the pharmacy used.

What are the major side effects associated with azathioprine?

Azathioprine is associated with an increased risk of lymphoma in patients with inflammatory bowel disease, among other side effects.

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

North America, Europe, and the Asia-Pacific region are expected to be significant drivers of the azathioprine market due to their large patient bases and advanced healthcare systems.

What are the key factors driving the growth of the azathioprine market?

The increasing prevalence of autoimmune diseases, advancements in biologics and immunosuppressants, and the cost-effectiveness of combination therapies are key drivers of the azathioprine market.

Sources

1. MarketResearchIntellect: Global Azathioprine Market Size, Trends and Projections[1]
2. PubMed: Economic impact of combination therapy with infliximab plus azathioprine[2]
3. Coherent Market Insights: Autoimmune Hepatitis Market - Report, Trends, Share & Insights[3]
4. Cognitive Market Research: Azathioprine Market Report 2024 (Global Edition)[4]
5. Medical News Today: Azathioprine cost 2024: Coupons and more[5]