IMURAN Drug Patent Profile

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

Imuran is a drug marketed by Casper Pharma Llc and Sebela Ireland Ltd and is included in two NDAs.

The generic ingredient in IMURAN is azathioprine. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the azathioprine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Imuran

A generic version of IMURAN was approved as azathioprine by AMNEAL on February 16^th, 1996.

Summary for IMURAN

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	35
Drug Prices:	Drug price information for IMURAN
What excipients (inactive ingredients) are in IMURAN?	IMURAN excipients list
DailyMed Link:	IMURAN at DailyMed

See drug prices for IMURAN

See drug sales revenues for IMURAN

Recent Clinical Trials for IMURAN

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

Sponsor	Phase
The University of Hong Kong	Phase 2
Vanderbilt University Medical Center	Early Phase 1
Veloxis Pharmaceuticals	Early Phase 1

See all IMURAN clinical trials

Pharmacology for IMURAN

Drug Class	Purine Antimetabolite
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

US Patents and Regulatory Information for IMURAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Casper Pharma Llc	IMURAN	azathioprine sodium	INJECTABLE;INJECTION	017391-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Sebela Ireland Ltd	IMURAN	azathioprine	TABLET;ORAL	016324-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Sebela Ireland Ltd	IMURAN	azathioprine	TABLET;ORAL	016324-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

EU/EMA Drug Approvals for IMURAN

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

IMURAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for IMURAN (Azathioprine)

Introduction

IMURAN, known generically as azathioprine, is an immunosuppressant drug that has been a cornerstone in the treatment of various medical conditions since its approval in 1968. This article delves into the market dynamics and financial trajectory of IMURAN, exploring its usage, pricing, and the factors influencing its market presence.

Approved Uses and Indications

Azathioprine is indicated for several critical medical conditions, including the prevention of rejection in renal homotransplantation and the management of active rheumatoid arthritis. It is also used, though not always approved, for treating inflammatory bowel diseases such as Crohn's disease and ulcerative colitis[2][4].

Market Presence and Usage

Azathioprine has been on the market for over five decades, with a significant presence in both hospital and community settings. In Canada, prescription data indicates that the use of azathioprine is increasing in the community while declining in hospitals[1].

Global Market

The drug is widely used globally, with approvals in multiple countries. Its long-standing presence has established it as a standard treatment option in immunosuppressive therapy. The global demand for immunosuppressants, driven by the increasing need for organ transplants and the management of autoimmune diseases, continues to support the market for azathioprine[4].

Pricing and Cost Factors

The cost of azathioprine can vary significantly based on several factors, including the form of the drug (oral or intravenous), the brand name (Imuran or Azasan), and the patient's insurance coverage.

Generic vs. Brand Name

Azathioprine is available as both brand-name drugs (Imuran and Azasan) and generic versions. The generic versions are generally more affordable, making the drug more accessible to a broader patient population. For instance, the cost of a 50mg tablet of generic azathioprine can be as low as $0.57, compared to the brand-name versions which can be several times more expensive[5].

Insurance and Financial Assistance

The cost to patients is also influenced by their insurance coverage and any available financial assistance programs. Many pharmaceutical companies offer savings programs or coupons that can reduce the out-of-pocket costs for patients. Additionally, government programs and non-profit organizations may provide financial assistance to patients who cannot afford the medication[5].

Financial Trajectory

The financial performance of azathioprine is influenced by several key factors:

Sales and Revenue

Despite being a generic drug, azathioprine continues to generate significant revenue due to its widespread use. The drug's long history and established position in the market contribute to its stable revenue stream. However, the revenue may fluctuate based on competition from newer immunosuppressive drugs and changes in healthcare policies.

Competition

The immunosuppressant market is competitive, with several other drugs available for similar indications. However, azathioprine's long-standing reputation and efficacy have helped it maintain a strong market position. Newer drugs may offer alternative treatment options, but azathioprine remains a preferred choice due to its well-understood side effect profile and cost-effectiveness[4].

Regulatory and Safety Considerations

Regulatory actions and safety reviews can impact the financial trajectory of azathioprine. For example, Health Canada conducted a safety review regarding the risk of progressive multifocal leukoencephalopathy (PML) associated with azathioprine, which led to updates in the Canadian Product Monograph. Such regulatory actions can influence prescribing practices and, consequently, the drug's market performance[1].

Safety and Efficacy

The safety and efficacy of azathioprine are crucial factors in its market dynamics. The drug is known for its immunosuppressive effects, which come with risks such as increased susceptibility to infections and malignancies. Despite these risks, azathioprine remains effective in managing its indicated conditions, which supports its continued use.

Side Effects and Risks

Azathioprine is associated with several serious side effects, including the risk of malignancy, severe infections, and hematologic toxicities. These risks necessitate careful monitoring and dose adjustments, which can impact patient compliance and, by extension, the drug's market performance[2][3].

Patient and Healthcare Provider Perspectives

The perspectives of both patients and healthcare providers play a significant role in the market dynamics of azathioprine.

Patient Compliance

Patient compliance is influenced by the drug's side effect profile, cost, and the availability of financial assistance programs. Patients who experience severe side effects may seek alternative treatments, while those who find the drug effective and affordable are more likely to adhere to their treatment regimen.

Healthcare Provider Preferences

Healthcare providers prefer drugs with well-established efficacy and safety profiles. Azathioprine's long history of use and extensive clinical data make it a preferred choice for many providers. However, the emergence of new immunosuppressive drugs with potentially better safety profiles could shift provider preferences over time[4].

Future Outlook

The future outlook for azathioprine is influenced by several factors, including advancements in immunosuppressive therapy, changes in healthcare policies, and the availability of generic versions.

Advancements in Therapy

Newer immunosuppressive drugs with improved safety profiles and efficacy may challenge azathioprine's market position. However, azathioprine's established reputation and cost-effectiveness are likely to maintain its relevance in the market.

Generic Competition

The availability of generic versions of azathioprine will continue to impact its pricing and accessibility. As more generic manufacturers enter the market, the cost of the drug is likely to decrease, making it more accessible to a broader patient population[5].

Key Takeaways

• Established Market Presence: Azathioprine has been a cornerstone in immunosuppressive therapy for over five decades.
• Pricing and Cost Factors: The cost of azathioprine varies based on brand name, generic availability, and insurance coverage.
• Safety and Efficacy: The drug is effective but comes with significant side effects, necessitating careful monitoring.
• Regulatory Considerations: Safety reviews and regulatory actions can impact prescribing practices and market performance.
• Future Outlook: Azathioprine will likely remain relevant due to its established reputation and cost-effectiveness, despite competition from newer drugs.

FAQs

What are the primary indications for IMURAN (azathioprine)?

IMURAN is primarily indicated for the prevention of rejection in renal homotransplantation and the management of active rheumatoid arthritis. It is also used for treating inflammatory bowel diseases, though not always approved for these conditions[2][4].

What are the significant side effects associated with azathioprine?

Azathioprine is associated with several serious side effects, including the risk of malignancy, severe infections, hematologic toxicities, and the rare but serious brain infection progressive multifocal leukoencephalopathy (PML)[1][2][3].

How does the cost of azathioprine vary?

The cost of azathioprine varies based on the brand name (Imuran or Azasan), generic availability, insurance coverage, and the pharmacy used. Generic versions are generally more affordable than brand-name versions[5].

What impact do regulatory actions have on azathioprine's market performance?

Regulatory actions, such as safety reviews and updates to product monographs, can influence prescribing practices and patient compliance, thereby affecting the drug's market performance[1].

Is azathioprine safe during pregnancy?

Azathioprine should be used with caution during pregnancy due to its potential to cause fetal harm. It is recommended to avoid its use in pregnant women unless the benefits outweigh the risks[3].

Sources

1. Health Canada: Summary Safety Review - Imuran (azathioprine) - Serious Brain Infection (Progressive Multifocal Leukoencephalopathy)[1].
2. FDA: IMURAN (azathioprine) 50-mg Scored Tablets Rx only WARNING[2].
3. FDA: IMURAN® (azathioprine) 50-mg Scored Tablets[3].
4. DrugBank: Azathioprine: Uses, Interactions, Mechanism of Action[4].
5. Medical News Today: Azathioprine cost 2024: Coupons and more[5].