{"id":"testosterone-enantate","rwe":[],"tags":[{"label":"Androgen","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Androgen receptor","category":"target"},{"label":"AR","category":"gene"},{"label":"Subcutaneous","category":"route"},{"label":"Intramuscular","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Deficiency of testosterone biosynthesis","category":"indication"},{"label":"Delayed puberty","category":"indication"},{"label":"Hormone receptor positive malignant neoplasm of breast","category":"indication"},{"label":"Klinefelter's syndrome, XXY","category":"indication"},{"label":"LHRH Deficiency","category":"indication"},{"label":"Male hypogonadism","category":"indication"},{"label":"Endo Pharms","category":"company"},{"label":"Approved 1950s","category":"decade"},{"label":"Androgens","category":"pharmacology"},{"label":"Hormones","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":171.361,"date":"","count":100,"signal":"Product dose omission issue","source":"DrugCentral FAERS","actionTaken":"Reported 100 times (LLR=171)"},{"llr":152.054,"date":"","count":46,"signal":"Device malfunction","source":"DrugCentral FAERS","actionTaken":"Reported 46 times (LLR=152)"},{"llr":138.779,"date":"","count":43,"signal":"Device dislocation","source":"DrugCentral FAERS","actionTaken":"Reported 43 times (LLR=139)"},{"llr":59.582,"date":"","count":14,"signal":"Ear congestion","source":"DrugCentral FAERS","actionTaken":"Reported 14 times (LLR=60)"},{"llr":46.431,"date":"","count":8,"signal":"Secondary hypogonadism","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=46)"},{"llr":44.394,"date":"","count":20,"signal":"Accidental exposure to product","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=44)"},{"llr":41.905,"date":"","count":28,"signal":"Migraine","source":"DrugCentral FAERS","actionTaken":"Reported 28 times (LLR=42)"},{"llr":40.394,"date":"","count":15,"signal":"Thyroid disorder","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=40)"},{"llr":38.756,"date":"","count":10,"signal":"Focal segmental glomerulosclerosis","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=39)"}],"commonSideEffects":[],"contraindications":["Asthma","Benign prostatic hyperplasia","Body fluid retention","Breast Carcinoma in Males","Breast lump","Breastfeeding (mother)","Carcinoma of female breast","Cardiovascular event risk","Cerebrovascular accident","Chloasma","Chorea","Chronic heart failure","Chronic lung disease","Deep venous thrombosis","Dementia","Diabetes mellitus","Disease of liver","Disorder of coronary artery","Disorder of gallbladder","Edema","Endometrial carcinoma","Endometriosis","Epilepsy","Estrogen receptor positive tumor","Family history of malignant neoplasm of breast"],"specialPopulations":{"Pregnancy":"XYOSTED is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm when administered to pregnant woman based on data from animal studies and its mechanism of action [see Contraindications (4) and Clinical Pharmacology (12.1)]. Exposure of female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies.","Geriatric use":"Clinical studies of testosterone enanthate did not include sufficient numbers of subjects, aged 65 and older, to determine whether they respond differently from younger subjects. Testosterone replacement is not indicated in geriatric patients who have age-related hypogonadism only (andropause), because there is insufficient safety and efficacy information to support such use. Current studies do not assess whether testosterone use increases risks of prostate cancer, prostate hyperplasia, or benign prostatic hypertrophy.","Paediatric use":"Androgen therapy should be used very cautiously in pediatric patients and only by specialists who are aware of the adverse effects on bone maturation. Skeletal maturation must be monitored every six months by an X-ray of the hand and wrist (see INDICATIONS AND USAGE and WARNINGS)."}},"trials":[],"aliases":[],"company":"Endo","patents":[{"source":"FDA Orange Book via DrugCentral","expires":"2038-08-30","territory":"US","patentNumber":"10646495"},{"source":"FDA Orange Book via DrugCentral","expires":"2036-09-04","territory":"US","patentNumber":"9950125"},{"source":"FDA Orange Book via DrugCentral","expires":"2035-11-19","territory":"US","patentNumber":"9744302"},{"source":"FDA Orange Book via DrugCentral","expires":"2035-10-18","territory":"US","patentNumber":"11191908"},{"source":"FDA Orange Book via DrugCentral","expires":"2035-02-19","territory":"US","patentNumber":"10238662"},{"source":"FDA Orange Book via DrugCentral","expires":"2035-02-19","territory":"US","patentNumber":"10912782"},{"source":"FDA Orange Book via DrugCentral","expires":"2034-10-07","territory":"US","patentNumber":"11160751"},{"source":"FDA Orange Book via DrugCentral","expires":"2034-02-11","territory":"US","patentNumber":"10881798"},{"source":"FDA Orange Book via DrugCentral","expires":"2033-06-04","territory":"US","patentNumber":"10821072"},{"source":"FDA Orange Book via DrugCentral","expires":"2031-08-21","territory":"US","patentNumber":"10357609"},{"source":"FDA Orange Book via DrugCentral","expires":"2031-08-21","territory":"US","patentNumber":"10905827"},{"source":"FDA Orange Book via DrugCentral","expires":"2031-08-21","territory":"US","patentNumber":"11446440"},{"source":"FDA Orange Book via DrugCentral","expires":"2031-07-31","territory":"US","patentNumber":"10279131"},{"source":"FDA Orange Book via DrugCentral","expires":"2030-03-19","territory":"US","patentNumber":"11497753"},{"source":"FDA Orange Book via DrugCentral","expires":"2026-10-04","territory":"US","patentNumber":"8021335"},{"source":"FDA Orange Book via DrugCentral","expires":"2026-01-24","territory":"US","patentNumber":"10478560"},{"source":"FDA Orange Book via DrugCentral","expires":"2026-01-24","territory":"US","patentNumber":"11446441"},{"source":"FDA Orange Book via DrugCentral","expires":"2026-01-24","territory":"US","patentNumber":"8562564"},{"source":"FDA Orange Book via DrugCentral","expires":"2026-01-24","territory":"US","patentNumber":"9180259"},{"source":"FDA Orange Book via DrugCentral","expires":"2026-01-24","territory":"US","patentNumber":"9533102"},{"source":"FDA Orange Book via DrugCentral","expires":"2026-01-24","territory":"US","patentNumber":"9629959"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$1.3280/GM","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$485","description":"TESTOSTERONE 1% (25 MG/2.5 G) PK","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=testosterone enantate","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:00:48.891083+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:00:47.276741+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T00:01:13.010193+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:00:54.580758+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=testosterone enantate","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:00:55.374919+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Androgen Receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:00:56.463503+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200335/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:00:56.112551+00:00"}},"allNames":"xyosted (autoinjector)","offLabel":[],"synonyms":["testosterone enanthate","testosterone heptylate","testosterone oenanthate","testosterone enantate"],"timeline":[{"date":"1953-12-24","type":"positive","source":"DrugCentral","milestone":"FDA approval (Endo Pharms)"}],"aiSummary":"Xyosted (testosterone enantate) is an autoinjector marketed by Endo for the treatment of testosterone deficiency, positioning it in a segment with several established and emerging competitors. A key strength of Xyosted is its unique autoinjector delivery system, which may offer convenience and improve patient adherence compared to other formulations. 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