Azathioprine - Generic Drug Details

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.

Summary for azathioprine

US Patents:	0
Tradenames:	4
Applicants:	8
NDAs:	8
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	306
Patent Applications:	6,880
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for azathioprine
Drug Sales Revenues:	Drug sales revenues for azathioprine
What excipients (inactive ingredients) are in azathioprine?	azathioprine excipients list
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
Nantes University Hospital	N/A
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	N/A
Cairo University	Phase 3

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

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
Zydus Pharms Usa	AZATHIOPRINE	azathioprine	TABLET;ORAL	077621-003	Sep 5, 2008	AB	RX	No	No
Zydus Pharms Usa	AZATHIOPRINE	azathioprine	TABLET;ORAL	077621-001	Mar 15, 2007	AB	RX	No	No
Aaipharma Llc	AZASAN	azathioprine	TABLET;ORAL	075252-004	Feb 3, 2003	AB	RX	No	No
Amneal	AZATHIOPRINE	azathioprine	TABLET;ORAL	074069-001	Feb 16, 1996	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