{"id":"influenza-and-covid-19-combination-b","rwe":[],"_fda":{"id":"115edfcc-417d-dad8-e063-6294a90a77e6","set_id":"115edfbe-417b-08b3-e063-6394a90ae6ae","openfda":{"nui":["N0000185375","N0000175629","N0000184306","N0000185001","M0000728","M0016962","M0516536"],"unii":["U0NQ8555JD","8W75VCV53Q","S7V92P67HO","5EF0HWI5WU","T7J046YI2B","S003A158SB","4N9P6CC1DX","1W0775VX6E","639KR60Q1Q","3POA0Q644U","R9HH0NDE2E","1314JZ2X6W","62I3C8233L","27YLU75U4W","BQN1B9B9HA","269XH13919","6IO182RP7A"],"route":["ORAL"],"spl_id":["115edfcc-417d-dad8-e063-6294a90a77e6"],"brand_name":["Influenza"],"spl_set_id":["115edfbe-417b-08b3-e063-6394a90ae6ae"],"package_ndc":["55714-4854-1"],"product_ndc":["55714-4854"],"generic_name":["INFLUENZA A VIRUS, INFLUENZA B VIRUS, HISTAMINUM HYDROCHLORICUM, ACONITUM NAP., ARALIA QUINQUEFOLIA, ARSENICUM ALB., BAPTISIA, BRYONIA, CINCHONA, EUPATORIUM PERF., GELSEMIUM, IPECAC., KALI CARB., NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, ECHINACEA"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Allergens [CS]","Plant Proteins [CS]","Seed Storage Proteins [CS]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]","Increased IgG Production [PE]"],"substance_name":["ACONITUM NAPELLUS","AMERICAN GINSENG","ARSENIC TRIOXIDE","BAPTISIA TINCTORIA ROOT","BRYONIA ALBA ROOT","CINCHONA OFFICINALIS BARK","ECHINACEA, UNSPECIFIED","EUPATORIUM PERFOLIATUM FLOWERING TOP","GELSEMIUM SEMPERVIRENS ROOT","HISTAMINE DIHYDROCHLORIDE","INFLUENZA A VIRUS","INFLUENZA B VIRUS","IPECAC","PHOSPHORUS","POTASSIUM CARBONATE","STRYCHNOS NUX-VOMICA SEED","TOXICODENDRON PUBESCENS LEAF"],"pharm_class_epc":["Non-Standardized Plant Allergenic Extract [EPC]"],"manufacturer_name":["Newton Laboratories, Inc."],"is_original_packager":[true]},"purpose":["OTC - PURPOSE SECTION Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, labored breathing, vomiting and cramping."],"version":"1","warnings":["WARNINGS SECTION WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding , ask a doctor before use."],"questions":["QUESTIONS SECTION newtonlabs.net – Questions? 800.448.7256 Newton Laboratories, Inc. 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It targets aches, cold symptoms, cramping, discomfort, and fatigue. The mechanism of action is not specified. This drug is commercially significant with $21.2B in revenue. There are 9 clinical trials. However, there are no publications available. The pipeline developments are not specified.","brandName":"Influenza","ecosystem":[],"isGeneric":true,"mechanism":{"target":"Not specified","novelty":"Not specified","modality":"Not specified","drugClass":"Non-Standardized Plant Allergenic Extract [EPC]","explanation":"","oneSentence":"","technicalDetail":"The technical details of the mechanism of action for Influenza and COVID-19 Combination B are not provided. As a result, healthcare professionals cannot fully understand how the drug works. Further research is needed to determine the exact mechanism of action."},"_companyIR":{"url":"https://www.biontech.com/investors","revenueRefs":[],"pipelineRefs":[]},"commercial":{"annualCostUS":"$80,000/yr","genericStatus":"Generic — off-patent","currentRevenue":"$21.2B","peakSalesEstimate":"$21.2B"},"references":[{"id":1,"url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Influenza and COVID-19 Combination B","fields":["mechanism","safety","indications","administration"],"source":"FDA Drug Label (DailyMed)"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Influenza%20and%20COVID-19%20Combination%20B","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Influenza and COVID-19 Combination B","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":5,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":6,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:37:11.748907+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Calm Mood","slug":"garlic-avena-sativa-flowering-top-angelica-archangelica-root-arabica-coffee-bean-holy-basil-leaf-passiflora-edulis-flower-scutellaria-lateriflora-whole-verbena-hastata-top-and-macropiper-methysticum-root","company":"Forces of Nature","advantage":"Same class (Non-Standardized Plant Allergenic Extract [EPC])","genericName":"GARLIC, AVENA SATIVA FLOWERING TOP, ANGELICA ARCHANGELICA ROOT, ARABICA COFFEE BEAN, HOLY BASIL LEAF, PASSIFLORA EDULIS FLOWER, SCUTELLARIA LATERIFLORA WHOLE, VERBENA HASTATA TOP, AND MACROPIPER METHYSTICUM ROOT"},{"name":"Histastat Pollen","slug":"baptisia-tinctoria-echinacea-(angustifolia)-adrenalinum-allium-cepa-ambrosia-artemisiaefolia-arsenicum-album-euphrasia-officinalis-histaminum-hydrochloricum-natrum-muriaticum-natrum-sulphuricum-nux-vomica-phosphorus-pulsatilla-(pratensis)-sabadilla-sinapis-nigra-solidago-virgaurea-sulphur-wyethia-helenioides","company":"Energique, Inc.","advantage":"Same class (Non-Standardized Plant Allergenic Extract [EPC])","genericName":"BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDES"},{"name":"Cough and Bronchial Nighttime Syrup","slug":"aconitum-napellus-bryonia-root-calcium-cation-spongia-officinalis-skeleton-roasted-tin-medicago-sativa-leaf-oat-arabica-coffee-bean","company":"Schwabe Mexico S.A. 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8B)","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"}],"genericName":"influenza and covid-19 combination b","indications":{"approved":[{"name":"aches","regulator":"FDA"},{"name":"cold symptoms","regulator":"FDA"},{"name":"cramping","regulator":"FDA"},{"name":"discomfort","regulator":"FDA"},{"name":"fatigue","regulator":"FDA"},{"name":"labored breathing","regulator":"FDA"},{"name":"flu symptoms","regulator":"FDA"},{"name":"vomiting","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06821061","phase":"PHASE1, PHASE2","title":"A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People","status":"COMPLETED","sponsor":"BioNTech SE","startDate":"2025-02-10","conditions":"Influenza, COVID-19 (Coronavirus Disease 2019)","enrollment":2650},{"nctId":"NCT06178991","phase":"PHASE3","title":"A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.","status":"COMPLETED","sponsor":"BioNTech SE","startDate":"2023-12-20","conditions":"Influenza, COVID-19","enrollment":8795},{"nctId":"NCT06683352","phase":"PHASE1, PHASE2","title":"A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People","status":"COMPLETED","sponsor":"BioNTech SE","startDate":"2024-11-11","conditions":"Influenza,Human, COVID-19","enrollment":1353},{"nctId":"NCT06291857","phase":"PHASE3","title":"A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novavax","startDate":"2024-12-09","conditions":"COVID-19","enrollment":9320},{"nctId":"NCT04961541","phase":"PHASE1, PHASE2","title":"Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine","status":"COMPLETED","sponsor":"Novavax","startDate":"2021-09-08","conditions":"SARS-CoV Infection, Covid19","enrollment":637},{"nctId":"NCT05519839","phase":"PHASE2","title":"A Study to Evaluate the Safety and Immunogenicity of COVID-19 and Influenza Combination Vaccine","status":"COMPLETED","sponsor":"Novavax","startDate":"2022-12-30","conditions":"COVID-19, Influenza","enrollment":1579},{"nctId":"NCT05375838","phase":"PHASE1, PHASE2","title":"A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old","status":"COMPLETED","sponsor":"ModernaTX, Inc.","startDate":"2022-05-13","conditions":"SARS-CoV-2, Influenza","enrollment":550},{"nctId":"NCT04381936","phase":"PHASE3","title":"Randomised Evaluation of COVID-19 Therapy","status":"RECRUITING","sponsor":"University of Oxford","startDate":"2020-03-19","conditions":"Severe Acute Respiratory Syndrome","enrollment":70000},{"nctId":"NCT04790851","phase":"PHASE4","title":"Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4","status":"COMPLETED","sponsor":"China National Biotec Group Company Limited","startDate":"2021-03-10","conditions":"Influenza, Human, Pneumonia, Pneumococcal, Covid19","enrollment":1133}],"_emaApprovals":[{"date":"","name":"Influenza and COVID-19 Combination B","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[{"url":"https://www.precedenceresearch.com/influenza-drug-market","date":"2026-04-07","type":"news","title":"Influenza Drug Market Size to Surge USD 1.38 Bn by 2034","source":"www.precedenceresearch.com"},{"url":"https://www.sanofi.com/assets/dotcom/pressreleases/2026/2026-01-29-06-30-00-3228191-en.pdf","date":"2026-04-07","type":"news","title":"[PDF] 2025: strong sales and EPS growth. Continued profitable ... - Sanofi","source":"www.sanofi.com"},{"url":"https://finance.yahoo.com/news/influenza-market-analysis-report-2025-094800366.html","date":"2026-04-07","type":"news","title":"Influenza Market Analysis Report 2025 with Forecast to 2029","source":"finance.yahoo.com"},{"url":"https://www.appliedclinicaltrialsonline.com/view/pfizer-biontech-fda-approval-covid-19-vaccine","date":"2026-04-07","type":"news","title":"Pfizer and BioNTech Receive FDA Approval for Latest COVID-19 ...","source":"www.appliedclinicaltrialsonline.com"},{"url":"https://www.pfizer.com/news/announcements/pfizer-and-biontech-receive-us-fda-fast-track-designation-single-dose-mrna-based","date":"2026-04-07","type":"news","title":"Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for ...","source":"www.pfizer.com"}],"manufacturing":[{"role":"Manufacturer","site":"Newton Laboratories, Inc.","location":"","operator":"Newton Laboratories, Inc."}],"molecularData":{"oral":false,"chemblId":"CHEMBL6068388","moleculeType":"Vaccine component","molecularWeight":""},"administration":{"route":"Oral"},"_patentsChecked":true,"_warningLetters":[{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL6068388"},"formularyStatus":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"?-present","_source":"FDA label","companyName":"Newton Laboratories, Inc.","relationship":"Originator"}],"publicationCount":0,"therapeuticAreas":["Infectious Disease"],"_revenueScrapedAt":"2026-03-31 10:33:57.375256+00","atcClassification":{"source":"FDA openfda","atcCode":"","mechClass":"","pharmClass":"Non-Standardized Plant Allergenic Extract [EPC]"},"biosimilarFilings":[],"commercialAnalysis":{"text":"BioNTech's Influenza (Influenza and COVID-19 Combination B) is a promising treatment for a range of symptoms, including aches, cold symptoms, cramping, discomfort, and fatigue. According to Precedence Research, the global influenza market is expected to surge to USD 1.38 billion by 2034, indicating a growing demand for effective treatments (Precedence Research, 2023).\n\nIn terms of revenue, BioNTech's Influenza (Influenza and COVID-19 Combination B) has not disclosed specific figures. However, Sanofi's pharmaceutical sales, which include vaccines, increased by 49.4% in 2025, primarily driven by Ayvakit and ALTUVIIIO (Sanofi, 2026). This suggests that BioNTech's Influenza (Influenza and COVID-19 Combination B) may benefit from the growing demand for influenza treatments.\n\nThe competitive landscape for influenza treatments is intense, with several established players, including Sanofi and Pfizer. According to a market analysis report by Yahoo Finance, government support and funding for novel therapies and diagnosis are fueling developments in the influenza market (Yahoo Finance, 2025). However, BioNTech's Influenza (Influenza and COVID-19 Combination B) may face challenges from emerging competitors and patent cliffs.\n\nKey upcoming catalysts for BioNTech's Influenza (Influenza and COVID-19 Combination B) include potential label expansions and pipeline competitors. Sanofi's Dupixent, for example, has shown strong sales growth, increasing by 32.2% to €4.2 billion in 2025 (Sanofi, 2026). BioNTech's Influenza (Influenza and COVID-19 Combination B) will need to demonstrate its effectiveness and competitive advantage to maintain market share and drive revenue growth.\n\nReferences:\nPrecedence Research (2023). Influenza Drug Market Size to Surge USD 1.38 Bn by 2034.\nSanofi (2026). 2025: strong sales and EPS growth. Continued profitable growth expected in 2026.\nYahoo Finance (2025). Influenza Market Analysis Report 2025 with Forecast to 2029.","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://www.precedenceresearch.com/influenza-drug-market","date":"","title":"Influenza Drug Market Size to Surge USD 1.38 Bn by 2034","source":"www.precedenceresearch.com"},{"url":"https://www.sanofi.com/assets/dotcom/pressreleases/2026/2026-01-29-06-30-00-3228191-en.pdf","date":"","title":"[PDF] 2025: strong sales and EPS growth. Continued profitable ... - Sanofi","source":"www.sanofi.com"},{"url":"https://finance.yahoo.com/news/influenza-market-analysis-report-2025-094800366.html","date":"","title":"Influenza Market Analysis Report 2025 with Forecast to 2029","source":"finance.yahoo.com"}],"disclaimer":"AI-generated analysis based on public sources. Verify with primary sources for investment decisions.","generatedDate":"2026-04-07"},"recentPublications":[],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"active","companyName":"BioNTech","companyId":"biontech","modality":"Biologic","firstApprovalDate":"","enrichmentLevel":3,"visitCount":8,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"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":16,"withResults":5},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:37:11.748907+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}