{"id":"famtozinameran-12-years-of-age-and-older","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Live vaccines","action":"Avoid","effect":"Decreased vaccine efficacy"},{"drug":"Interferons","action":"Monitor","effect":"Increased risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine-associated enhanced disease"},{"drug":"Immunosuppressive therapies","action":"Monitor","effect":"Decreased immune response to the vaccine"},{"drug":"Chloroquine or hydroxychloroquine","action":"Monitor","effect":"Decreased immune response to the vaccine"},{"drug":"Azithromycin","action":"Monitor","effect":"Decreased immune response to the vaccine"},{"drug":"Other medications that suppress the immune system","action":"Monitor","effect":"Decreased immune response to the vaccine"}],"commonSideEffects":[],"contraindications":["Dosage adjustment in patients with liver or kidney impairment is not addressed in the product information for these vaccines."],"specialPopulations":{"Pregnancy":"No information available","Geriatric use":"One of these ongoing studies has reported results for people older than 55 years who had received 3 previous doses of tozinameran.","Paediatric use":"Tozinameran+famtozinameran can be used in people 12 years and older.","Renal impairment":"Dosage adjustment in patients with liver or kidney impairment is not addressed in the product information for these vaccines.","Hepatic impairment":"Dosage adjustment in patients with liver or kidney impairment is not addressed in the product information for these vaccines."},"seriousAdverseEvents":[]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T20:58:42.499793+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T20:58:50.043337+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL13829/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T20:58:36.226910+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T20:58:51.251933+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T20:58:34.955365+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T20:58:51.251928+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T20:58:51.251926+00:00"},"commercial.annualRevenue":{"url":"","method":"deterministic","source":"SEC EDGAR 10-K","rawText":"$4367M FY2025","confidence":0.8,"sourceType":"sec_edgar","retrievedAt":"2026-04-19T20:58:42.499835+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T20:58:51.251863+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T20:58:51.251895+00:00"}},"allNames":"famtozinameran 12 years of age and older","offLabel":[],"timeline":[],"aiSummary":"Famtozinameran 12 Years of age and older, developed by Pfizer, holds a significant market position as the world's best-selling drug with revenues of $4367M. Its competitive advantage lies in its combination with Tozinameran and Riltozinameran, offering broad protection against multiple variants including BA.1 and BA.4-5. A key risk is the requirement for a PD-L1 companion diagnostic for several indications, which may limit its accessibility and market reach. The pipeline outlook remains robust, with no ongoing clinical trials but a strong foundation in existing approved indications and combination therapies.","brandName":"Famtozinameran 12 Years of age and older","ecosystem":[],"isGeneric":true,"mechanism":{"target":"SARS-CoV-2 virus","novelty":"best-in-class","modality":"monoclonal antibody","drugClass":"monoclonal antibody","explanation":"Famtozinameran is a drug designed to prevent and treat COVID-19. It targets the SARS-CoV-2 virus, which causes the disease. By targeting this virus, famtozinameran can help prevent and treat COVID-19. This mechanism of action is crucial in understanding how the drug works and its potential benefits.","oneSentence":"Famtozinameran works by targeting the SARS-CoV-2 virus.","technicalDetail":"Famtozinameran is a monoclonal antibody that targets the SARS-CoV-2 virus by binding to its spike protein. This binding prevents the virus from entering host cells, thereby preventing infection. The drug's mechanism of action is based on its ability to neutralize the virus."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"chemblData":{"prodrug":-1,"chemblId":"CHEMBL13829","maxPhase":null,"chirality":-1,"parenteral":false,"availability":-1,"moleculeType":"Small molecule","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{"revenueYear":2025,"annualCostUS":"$80,000/yr","annualRevenue":4367,"genericStatus":"Biologic — patent protected","revenueSource":"SEC 8-K Pfizer (2026-02-03)","currentRevenue":"$21.2B","revenueCurrency":"USD","patientPopulation":"12 years and older","peakSalesEstimate":"$21.2B","revenueConfidence":"verified (SEC filing)","revenueExtractedAt":"2026-04-01T11:46:06.061447","revenueExtractedBy":"revenue-sec"},"fdaRecalls":[],"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=famtozinameran-12-years-of-age-and-older","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=famtozinameran-12-years-of-age-and-older","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":5,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T07:55:02.621267+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Tozinameran+riltozinameran","company":"Pfizer","advantage":"Provides some protection against BA.4-5 as well as BA.1"},{"name":"Tozinameran+famtozinameran","company":"Pfizer","advantage":"Provides some protection against BA.1 as well as BA.4-5"}],"dataSources":[{"url":"https://tavily.com","name":"Tavily AI Search","fields":["latestUpdates"],"retrievedDate":"2026-04-07"},{"url":"https://jina.ai/reader","name":"Jina Reader","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"},{"url":"https://groq.com","name":"Groq (Llama 3.1 8B)","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"}],"genericName":"famtozinameran-12-years-of-age-and-older","indications":{"approved":[{"name":"COVID-19 prevention","regulator":"FDA"},{"name":"COVID-19 treatment","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[],"_emaApprovals":[{"date":"","name":"Famtozinameran 12 Years of age and older","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[{"url":"https://intuitionlabs.ai/articles/pharmaceutical-market-analysis-trends","date":"2026-04-07","type":"news","title":"Global Pharmaceutical Market: 2025 Analysis & Key Trends | IntuitionLabs","source":"intuitionlabs.ai"},{"url":"https://www.statista.com/statistics/973523/top-drugs-by-year-on-year-sales-increase/","date":"2026-04-07","type":"news","title":"Major pharmaceutical drugs by global sales 2025| Statista","source":"www.statista.com"},{"url":"https://www.ema.europa.eu/en/news-events/whats-new/last-month","date":"2026-04-07","type":"news","title":"What's new | European Medicines Agency (EMA)","source":"www.ema.europa.eu"},{"url":"https://cdn.pfizer.com/pfizercom/product-pipeline/Q3%202025%20Pipeline%20Update_vFinal2.pdf?VersionId=P0rxbPkdVnYPsxzIj_uO3wzb.sXa287Z","date":"2026-04-07","type":"news","title":"[PDF] Pfizer Pipeline","source":"cdn.pfizer.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19-vaccine-comirnatyr-receives-full","date":"2026-04-07","type":"news","title":"Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older | Pfizer","source":"www.pfizer.com"}],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL13829","moleculeType":"Small molecule","molecularWeight":"768.84"},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL13829"},"formularyStatus":[],"_offLabelChecked":true,"chemblMechanisms":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Infectious Disease"],"_revenueScrapedAt":"2026-04-01 10:46:06.083601+00","biosimilarFilings":[],"commercialAnalysis":{"text":"Famtozinameran, developed by Pfizer, is a COVID-19 prevention and treatment medication targeting the SARS-CoV-2 virus. As of 2025, the global pharmaceutical market is projected to reach $1.6 trillion, with a steady compound annual growth rate (CAGR) of 3-6% from pre-pandemic levels (IntuitionLabs, 2025). Famtozinameran's revenue is not explicitly stated, but the global pharmaceutical market has seen significant growth, with revenues around $1.6 trillion in 2023, up by over $100 billion from 2022 (Jonicon, 2023).\n\nThe competitive landscape for Famtozinameran is dominated by oncology treatments, with Keytruda being the world's top-selling pharmaceutical drug in the first half of 2025, generating $15 billion in global sales (Statista, 2026). Merck & Co. has seen its overall revenue increase to $64 billion in 2024, driven largely by its oncology franchise (Merck & Co., 2024). However, Famtozinameran faces threats from patent cliffs, such as AbbVie's Humira, which dropped out of the top 10 best-selling drugs in 2024 due to patent expiration (Statista, 2026).\n\nKey upcoming catalysts for Famtozinameran include label expansions and pipeline competitors. The European Medicines Agency (EMA) has published updates on new and updated information on their website, including a pediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension (EMA, 2026). Additionally, the EMA is working to improve the usability of their search function, which may impact search results (EMA, 2026).\n\nThe market outlook for Famtozinameran is uncertain, with the global pharmaceutical market expected to continue growing, driven by rising global demand for medications and continual advancements in medical science and biotechnology (IntuitionLabs, 2025). However, Famtozinameran's revenue trajectory and market position are not explicitly stated, and further research is needed to determine its specific market outlook.","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://intuitionlabs.ai/articles/pharmaceutical-market-analysis-trends","date":"","title":"Global Pharmaceutical Market: 2025 Analysis & Key Trends | IntuitionLabs","source":"intuitionlabs.ai"},{"url":"https://www.statista.com/statistics/973523/top-drugs-by-year-on-year-sales-increase/","date":"","title":"Major pharmaceutical drugs by global sales 2025| Statista","source":"www.statista.com"},{"url":"https://www.ema.europa.eu/en/news-events/whats-new/last-month","date":"","title":"What's new | European Medicines Agency (EMA)","source":"www.ema.europa.eu"}],"disclaimer":"AI-generated analysis based on public sources. Verify with primary sources for investment decisions.","generatedDate":"2026-04-07"},"recentPublications":[],"_drugWebsiteChecked":true,"participantFlowData":[],"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"structuredTrialResults":[],"genericManufacturerList":[],"phase":"marketed","status":"active","companyName":"Pfizer","companyId":"pfizer","modality":"Vaccine","firstApprovalDate":"","enrichmentLevel":5,"visitCount":12,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"80000.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":2,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T07:55:02.621267+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":false,"score":2}}