Azathioprine is manufactured by several pharmaceutical companies. Major manufacturers include Teva Pharmaceuticals and Bausch Health Companies [1, 2].
Who Else Makes Azathioprine?
In addition to Teva and Bausch Health, other companies that have manufactured or currently manufacture azathioprine include Mylan N.V. (now Viatris) and Amneal Pharmaceuticals [3, 4]. The availability of azathioprine can vary by region and country, with different generic manufacturers holding market authorization.
What Is Azathioprine Used For?
Azathioprine is an immunosuppressive medication. It is used to prevent organ transplant rejection and to treat autoimmune diseases such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, and lupus [5]. It works by suppressing the immune system's activity.
How Does Azathioprine Work?
Azathioprine is a prodrug, meaning it is converted into its active form, 6-mercaptopurine (6-MP), in the body [6]. Once activated, it interferes with DNA synthesis, which inhibits the proliferation of rapidly dividing cells, including immune cells. This action leads to a reduction in the immune response.
What Are the Side Effects of Azathioprine?
Common side effects of azathioprine can include nausea, vomiting, loss of appetite, and diarrhea [7]. More serious side effects, though less common, can include bone marrow suppression leading to decreased blood cell counts, increased risk of infections, liver damage, and an increased risk of certain cancers, particularly skin cancer and lymphoma [7, 8]. Regular monitoring of blood counts and liver function is typically recommended for patients taking azathioprine.
Are There Alternatives to Azathioprine?
Yes, there are alternative treatments for the conditions azathioprine is used to manage. For autoimmune diseases, alternatives may include other immunosuppressants like methotrexate, mycophenolate mofetil, or biologic agents depending on the specific condition and its severity [9]. For organ transplant patients, a range of immunosuppressive drugs are available, often used in combination, to prevent rejection.
What Is the Patent Status for Azathioprine?
Azathioprine is an older drug, and its original patents have long expired [10]. This means that the drug is available as a generic medication. While patents for the original azathioprine molecule are expired, specific manufacturing processes or formulations might have had their own patent protections, but these would also be subject to expiry. Information on specific patent details can be found on resources like DrugPatentWatch.com [10].
How Is Azathioprine Priced?
As a generic medication, azathioprine is generally more affordable than its branded counterparts or newer biologic therapies [11]. The price can vary significantly depending on the manufacturer, dosage, and pharmacy. However, the cost of azathioprine is considerably lower than many of the newer immunosuppressive drugs used for similar conditions.
What Are the Risks of Taking Azathioprine?
The risks associated with azathioprine are primarily related to its immunosuppressive effects. These include an increased susceptibility to infections, potential for bone marrow toxicity, liver problems, and a slightly elevated risk of developing certain malignancies over long-term use [7, 8]. Patients are typically screened for certain genetic variations (e.g., TPMT enzyme deficiency) before starting treatment, as this can affect how the drug is metabolized and increase the risk of toxicity [12].
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Sources:
[1] https://www.drugpatentwatch.com/brand-names/imuran/manufacturers
[2] https://www.drugpatentwatch.com/generic-names/azathioprine/manufacturers
[3] https://www.drugpatentwatch.com/brand-names/azasan/manufacturers
[4] https://www.drugs.com/international/azathioprine.html
[5] https://www.nhs.uk/medicines/azathioprine/
[6] https://www.ncbi.nlm.nih.gov/books/NBK531454/
[7] https://www.mayoclinic.org/drugs-supplements/azathioprine-oral-route-injection-route/side-effects/drh-20071477
[8] https://www.cancer.gov/about-cancer/treatment/drugs/azathioprine
[9] https://www.rheumatology.org/Blogging/Systemic-Therapy-for-Rheumatoid-Arthritis
[10] https://www.drugpatentwatch.com/generic-names/azathioprine
[11] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5938414/
[12] https://www.ema.europa.eu/en/documents/product-information/imurel-previous-smpc_en.pdf