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Last Updated: December 2, 2022

Azathioprine - Generic Drug Details


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What are the generic sources for azathioprine and what is the scope of freedom to operate?

Azathioprine is the generic ingredient in four branded drugs marketed by Aaipharma Llc, Alkem Labs Ltd, Amneal, Rising, Zydus Pharms Usa, Sebela Ireland Ltd, Hikma, and Casper Pharma Llc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for azathioprine. Eleven suppliers are listed for this compound.

Drug Prices for azathioprine

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Drug Sales Revenue Trends for azathioprine

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Recent Clinical Trials for azathioprine

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SponsorPhase
Nantes University HospitalN/A
Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesN/A
Cairo UniversityPhase 3

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Pharmacology for azathioprine
Medical Subject Heading (MeSH) Categories for azathioprine

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
Rising AZATHIOPRINE azathioprine TABLET;ORAL 075568-001 Dec 13, 1999 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms Usa AZATHIOPRINE azathioprine TABLET;ORAL 077621-003 Sep 5, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms Usa AZATHIOPRINE azathioprine TABLET;ORAL 077621-001 Mar 15, 2007 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aaipharma Llc AZASAN azathioprine TABLET;ORAL 075252-004 Feb 3, 2003 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal AZATHIOPRINE azathioprine TABLET;ORAL 074069-001 Feb 16, 1996 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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