AZASAN Drug Patent Profile

Which patents cover Azasan, and what generic alternatives are available?

Azasan is a drug marketed by Aaipharma Llc and is included in one NDA.

The generic ingredient in AZASAN 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 Azasan

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

Summary for AZASAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	1
Patent Applications:	4,273
Drug Prices:	Drug price information for AZASAN
DailyMed Link:	AZASAN at DailyMed

See drug prices for AZASAN

Recent Clinical Trials for AZASAN

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

Sponsor	Phase
Immune Tolerance Network (ITN)	Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2

See all AZASAN clinical trials

Pharmacology for AZASAN

Drug Class	Purine Antimetabolite
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

US Patents and Regulatory Information for AZASAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aaipharma Llc	AZASAN	azathioprine	TABLET;ORAL	075252-002	Feb 3, 2003	AB	RX	No	No
Aaipharma Llc	AZASAN	azathioprine	TABLET;ORAL	075252-004	Feb 3, 2003	AB	RX	No	No
Aaipharma Llc	AZASAN	azathioprine	TABLET;ORAL	075252-001	Jun 7, 1999	AB	RX	No	No
Aaipharma Llc	AZASAN	azathioprine	TABLET;ORAL	075252-003	Feb 3, 2003	AB	RX	No	No

EU/EMA Drug Approvals for AZASAN

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

AZASAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Azasan (Azathioprine)

Overview of Azasan

Azasan, also known as azathioprine, is an immunosuppressive antimetabolite used in the management of various medical conditions, including the prevention of rejection in renal homotransplantation and the treatment of active rheumatoid arthritis[2].

Market Segmentation and Application

Indications

Azasan is indicated for two primary uses:

• Renal Homotransplantation: To prevent the body from rejecting a transplanted kidney.
• Rheumatoid Arthritis: To reduce the signs and symptoms of active rheumatoid arthritis[2].

Patient Base

The patient base for Azasan includes individuals undergoing kidney transplants and those suffering from rheumatoid arthritis. The demand for this drug is influenced by the prevalence of these conditions and the need for effective immunosuppressive treatments.

Market Size and Growth

While specific market size data for Azasan alone is not readily available, the broader context of immunosuppressive and rheumatoid arthritis drugs provides insight into its potential market dynamics.

Global Immunomodulators Market

The global market for immunomodulators, which includes drugs like azathioprine, is part of a larger pharmaceutical landscape. For instance, the ulcerative colitis drug market, which also involves immunomodulators, is expected to grow from USD 7.97 billion in 2023 to USD 12.98 billion by 2033, at a CAGR of 5%[1].

Specific to Azasan

Although Azasan is a generic drug, its market performance is tied to the overall demand for immunosuppressive and anti-rheumatoid arthritis treatments. The increasing prevalence of autoimmune diseases and the need for transplant rejection prevention drive the demand for such drugs.

Financial Trajectory

Cost and Pricing

The cost of azathioprine can vary based on several factors, including insurance coverage, treatment plan, and the pharmacy used. As a generic drug, it is generally more affordable than brand-name alternatives, but prices can still fluctuate. For example, the cost of azathioprine with and without insurance can differ significantly, and savings programs may be available to reduce the financial burden[5].

Revenue Impact

The revenue generated by Azasan is influenced by its prescription volume and pricing. Given its generic status, the drug faces competition from other generic versions, which can impact pricing and revenue. However, its established use and efficacy in treating specific conditions ensure a steady demand.

Pharmaceutical Industry Trends

The pharmaceutical industry, particularly the segment dealing with immunosuppressants and rheumatoid arthritis treatments, is subject to various trends:

• Price Increases: Prescription drug prices, including those for immunosuppressants, have seen significant increases over the years. From January 2022 to January 2023, the average drug price increase was 15.2%, which translates to $590 per drug product[4].
• Generic Drugs: The development and availability of generic drugs like azathioprine provide opportunities for cost savings but also introduce pricing pressures on the market.
• Technological Advancements: Advances in technology and research can lead to the development of new drugs and treatment modalities, potentially affecting the market share of existing drugs like Azasan.

Competitive Landscape

Key Players

The market for immunosuppressive and anti-rheumatoid arthritis drugs is competitive, with several key players involved in research, development, and marketing. Companies focus on strategies such as product innovations, mergers and acquisitions, and partnerships to maintain or improve their market position[1].

Emergence of Biosimilars

The emergence of biosimilars is a significant factor in the market dynamics of immunosuppressive drugs. Biosimilars offer cost-effective alternatives to biologic drugs, which can impact the market share of traditional immunosuppressants like azathioprine[1].

Challenges and Opportunities

Side Effects and Safety Concerns

Azasan is associated with several side effects, including hematologic and gastrointestinal toxicities, and risks of secondary infection and malignancy. These safety concerns can affect patient compliance and market growth[2].

Generic Drug Opportunities

The availability of generic versions of azathioprine presents opportunities for cost savings and increased accessibility. However, it also introduces competition that can affect pricing and revenue for the drug[5].

Technological Advancements

Technological advancements in pharmaceutical research can lead to the development of new, more effective treatments, which may compete with Azasan. However, these advancements can also improve the efficacy and safety profile of existing drugs, enhancing their market position[1].

Regional Analysis

Global Market

The global market for immunosuppressive and rheumatoid arthritis drugs is segmented by region, with North America often being a significant market due to high healthcare spending and advanced medical infrastructure. For example, the North America region accounted for 44.3% of the ulcerative colitis drug market revenue in 2023[1].

Key Takeaways

• Market Growth: The market for immunosuppressive and rheumatoid arthritis drugs, including Azasan, is expected to grow due to increasing prevalence rates and ongoing research.
• Pricing Dynamics: The cost of Azasan can vary based on insurance, treatment plans, and pharmacy choices, with generic versions offering cost savings.
• Competitive Landscape: The market is competitive, with key players focusing on innovations, mergers, and partnerships.
• Challenges and Opportunities: Side effects and safety concerns are significant challenges, while the emergence of biosimilars and generic drugs present both opportunities and competition.

FAQs

What is Azasan used for?

Azasan (azathioprine) is used to prevent the body from rejecting a transplanted kidney and to manage active rheumatoid arthritis[2].

How does the cost of Azasan vary?

The cost of Azasan varies based on factors such as insurance coverage, treatment plan, and the pharmacy used. Savings programs may also be available[5].

What are the side effects of Azasan?

The principal and potentially serious toxic effects of Azasan include hematologic and gastrointestinal toxicities, as well as risks of secondary infection and malignancy[2].

How does the emergence of biosimilars affect Azasan?

The emergence of biosimilars provides cost-effective alternatives to biologic drugs, which can impact the market share of traditional immunosuppressants like Azasan[1].

What are the regional market dynamics for Azasan?

The North America region is often a significant market for immunosuppressive and rheumatoid arthritis drugs, accounting for a substantial portion of the global revenue[1].

Sources

1. The Brainy Insights: Ulcerative Colitis Drug Market - Forecast to 2033
2. RxList: Azasan (azathioprine): Side Effects, Uses, Dosage, Interactions
3. PR Newswire: Azenta Reports Fourth Quarter and Full Year Fiscal 2024 Results
4. ASPE: Changes in the List Prices of Prescription Drugs, 2017-2023
5. MedicalNewsToday: Azathioprine cost 2024: Coupons and more