{"id":"acyc","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Generic Available","category":"availability"},{"label":"LOE Approaching","category":"status"},{"label":"Ligand Pharms","category":"company"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Malaise","drugRate":"11.5%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"4.8%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"3.2%","severity":"common","organSystem":""},{"effect":"Nausea and/or vomiting","drugRate":"2.7%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"2.7%","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"2.2%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"2.4%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"2.4%","severity":"common","organSystem":""}],"contraindications":["Adrenal cortical hypofunction","Atrophoderma","Breastfeeding (mother)","Cardiovascular event risk","Cerebrovascular accident","Dehydration","Diabetes mellitus","Hemolytic uremic syndrome","Hypercholesterolemia","Hyperglycemia","Hypertensive disorder","Impaired renal function disorder","Kidney disease","Myocardial infarction","Obesity","Osteopenia","Peripheral vascular disease","Pregnancy, function","Smokes tobacco daily","Telangiectasia disorder","Thrombotic thrombocytopenic purpura","Urinary tract obstruction","Vertebral Metastases"],"seriousAdverseEvents":[{"effect":"Stevens-Johnson Syndrome (SJS)","drugRate":"","severity":"serious"},{"effect":"Toxic epidermal necrolysis (TEN)","drugRate":"","severity":"serious"},{"effect":"Encephalopathy","drugRate":"","severity":"serious"},{"effect":"Renal failure","drugRate":"","severity":"serious"},{"effect":"Anaphylaxis","drugRate":"","severity":"serious"},{"effect":"Seizure","drugRate":"","severity":"serious"},{"effect":"Hepatitis","drugRate":"","severity":"serious"},{"effect":"Angioedema","drugRate":"","severity":"serious"},{"effect":"Coma","drugRate":"","severity":"serious"},{"effect":"Thrombocytopenia","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Ligand Pharms","patents":[{"applNo":"N203791","source":"FDA Orange Book","status":"Active","expires":"Jun 3, 2027","useCode":"U-1460","territory":"US","drugProduct":true,"patentNumber":"8747896","drugSubstance":false},{"applNo":"N203791","source":"FDA Orange Book","status":"Active","expires":"Jun 16, 2030","useCode":"U-1460","territory":"US","drugProduct":true,"patentNumber":"8592434","drugSubstance":false},{"applNo":"N203791","source":"FDA Orange Book","status":"Active","expires":"Mar 23, 2027","useCode":"U-1460","territory":"US","drugProduct":true,"patentNumber":"8791127","drugSubstance":false}],"pricing":[],"allNames":["acyc"],"offLabel":[],"synonyms":[],"timeline":[{"date":"1982-03-29","type":"positive","source":"FDA Orange Book","milestone":"Zovirax approved — 5%"},{"date":"1985-01-25","type":"positive","source":"FDA Orange Book","milestone":"Zovirax approved — 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"1989-12-22","type":"positive","source":"FDA Orange Book","milestone":"Zovirax approved — 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"1991-04-30","type":"positive","source":"FDA Orange Book","milestone":"Zovirax approved — 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"1998-04-13","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 13 manufacturers approved"},{"date":"2000-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from Bausch Health Americas, Inc. to Ligand Pharms"},{"date":"2002-12-30","type":"positive","source":"FDA Orange Book","milestone":"Zovirax approved — 5%"},{"date":"2019-03-29","type":"positive","source":"FDA Orange Book","milestone":"Avaclyr approved — 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"}],"approvals":[],"ecosystem":[],"mechanism":{"target":"Purine nucleoside phosphorylase, DNA polymerase catalytic subunit, Purine nucleoside phosphorylase","modality":"Small Molecule","explanation":"Think of acyc like a key that fits into a lock in the body. When it binds to its target, it can help to either block or activate certain processes, depending on the specific effect it's intended to have. However, without more information about its target and mechanism, it's difficult to say exactly how it works.","oneSentence":"Acyc works by binding to a specific target in the body, although its exact mechanism is unknown.","technicalDetail":"Acyc's mechanism of action is not well understood, but it is believed to involve binding to a specific protein or receptor in the body, potentially altering its activity or expression."},"commercial":{},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=acyc","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=acyc","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-31T10:27:08.958321","biosimilars":[],"competitors":[],"genericName":"acyc","indications":{"approved":[{"name":"Encephalitis due to Herpesvirus","diseaseId":"encephalitis-due-to-herpesvirus","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Genital herpes simplex","diseaseId":"genital-herpes-simplex","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Herpes labialis","diseaseId":"herpes-labialis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Herpes simplex","diseaseId":"herpes-simplex","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Herpes simplex infection of skin","diseaseId":"herpes-simplex-infection-of-skin","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Herpes zoster","diseaseId":"herpes-zoster","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Recurrent Mucocutaneous Herpes Simplex","diseaseId":"recurrent-mucocutaneous-herpes-simplex","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Recurrent genital herpes simplex","diseaseId":"recurrent-genital-herpes-simplex","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Recurrent herpes simplex labialis","diseaseId":"recurrent-herpes-simplex-labialis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Suppression of Recurrent Herpes Simplex Infection","diseaseId":"suppression-of-recurrent-herpes-simplex-infection","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Varicella","diseaseId":"varicella","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"currentOwner":"Ligand Pharms","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT01701024","phase":"PHASE3","title":"Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2012-10","conditions":["Acne"],"enrollment":498,"completionDate":"2013-07"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"_patentsChecked":true,"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Bausch Health Americas, Inc.","relationship":"Original Developer"},{"period":"present","companyName":"Ligand Pharms","relationship":"Current Owner"}],"publicationCount":2,"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"originalDeveloper":"Bausch Health Americas, Inc.","recentPublications":[],"companionDiagnostics":[],"genericManufacturers":48,"_genericFilersChecked":true,"genericManufacturerList":["Actavis Elizabeth","Actavis Mid Atlantic","Alembic","Amneal","Amneal Pharms","Apotex","Aurobindo Pharma","Aurobindo Pharma Usa","Cadila","Cadila Pharms Ltd","Carlsbad","Chartwell Molecular","Chartwell Molecules","Chartwell Rx","Cipla","Cosette","Fougera Pharms Inc","Glenmark Speclt","Heritage","Hetero Labs Ltd Iii","Hetero Labs Ltd V","Hikma","Ivax Sub Teva Pharms","Lek Pharm","Macleods Pharms Ltd","Msn","Mylan","Novitium Pharma","Padagis Israel","Pharmobedient","Prinston Inc","Ranbaxy","Regcon Holdings","Roxane","Rubicon Research","Square Pharms","Strides Pharma Intl","Sun Pharm Inds Ltd","Sun Pharma Canada","Teva","Teva Pharms","Torrent","Vistapharm Llc","Watson Labs","Xiromed","Yiling","Zydus Lifesciences","Zydus Pharms"],"status":"active","brandName":"ACYC","companyName":"Ligand Pharms","companyId":"ligand-pharms","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Acyc is a small molecule drug developed by Bausch Health Americas, Inc. and currently owned by Ligand Pharmaceuticals. Its target and drug class are unknown, but it has been approved by 48 generic manufacturers, indicating it is off-patent. The commercial status of acyc is unclear, but it is likely available as a generic medication. Key safety considerations are unknown, and further research is needed to understand its effects on patients.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}