FDA.reportPublic FDA data

Purple Book biologic products

BLAs With Published Patents#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameApplicantPatentsSource updated
125387EyleaafliberceptRegeneron Pharmaceuticals, Inc.882025-06-11
125057HumiraadalimumabAbbVie Inc.662025-06-11
125320Prolia, XgevadenosumabAmgen Inc.572025-06-11
125409PerjetapertuzumabGenentech, Inc.472025-06-11
125276ActemratocilizumabGenentech, Inc.352025-06-11
125104TysabrinatalizumabBiogen Inc.322025-06-11
125085AvastinbevacizumabGenentech, Inc.222025-06-11
103705RituxanrituximabGenentech, Inc.152025-06-11
125289SimponigolimumabJanssen Biotech, Inc.142025-06-11
125433Simponi AriagolimumabJanssen Biotech, Inc.122025-06-11
125156LucentisranibizumabGenentech, Inc.112025-06-11
103976XolairomalizumabGenentech, Inc.82025-06-11
125261StelaraustekinumabJanssen Biotech, Inc.62025-06-11
761044StelaraustekinumabJanssen Biotech, Inc.62025-06-11
103792HerceptintrastuzumabGenentech, Inc.42025-06-11
125031Neulasta, Neulasta OnpropegfilgrastimAmgen Inc.12025-06-11

Recently Updated BLAs#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameApplicantProductsPatentsCoverage
761498Avtozmatocilizumab-anohCELLTRION, Inc.2None listedCurrent release
761485Avlayahtividenofusp alfa-eknmDenali Therapeutics Inc.1None listedCurrent release
761484Rybrevant Fasproamivantamab and hyaluronidase-lpujJanssen Biotech, Inc.4None listedCurrent release
761473Nufymcoranibizumab-leykFormycon AG2None listedCurrent release
761468Hepcludexbulevirtide-gmodGilead Sciences, Inc.1None listedCurrent release
761467Keytruda Qlexpembrolizumab and berahyaluronidase alfa-pmphMerck Sharp & Dohme LLC2None listedCurrent release
761460Decnupazpivekimab sunirine-pvzyAbbVie Inc.1None listedCurrent release
761458Exdensurdepemokimab-ulaaGlaxoSmithKline LLC2None listedCurrent release
761457Oziltusdenosumab-mobzAmneal Pharmaceuticals LLC1None listedCurrent release
761456Boncresadenosumab-mobzAmneal Pharmaceuticals LLC1None listedCurrent release
761451Saphneloanifrolumab-fniaAstraZeneca AB2None listedCurrent release
761450Poherdypertuzumab-dpzbShanghai Henlius Biotech, Inc.1None listedCurrent release
761449Tyennetocilizumab-aazgFresenius Kabi USA, LLC2None listedCurrent release
761444Bildyos, Bilprevdadenosumab-nxxpShanghai Henlius Biotech, Inc.3None listedCurrent release
761440Blenrepbelantamab mafodotin-blmfGlaxoSmithKline LLC1None listedCurrent release
761439Enoby, Xtrenbodenosumab-qbdeHikma Pharmaceuticals USA Inc.2None listedCurrent release
761436Bosaya, Aukelsodenosumab-kyqqBiocon Biologics Inc.2None listedCurrent release
761434Voyxactsibeprenlimab-szsiOtsuka Pharmaceutical Company, Ltd.1None listedCurrent release
761432Enflonsiaclesrovimab-cforMerck Sharp & Dohme LLC1None listedCurrent release
761430Imaavynipocalimab-aahuJanssen Biotech, Inc.2None listedCurrent release
761427Lerochollerodalcibep-ligaLIB Therapeutics, Inc.1None listedCurrent release
761425Pyzchivaustekinumab-ttweSamsung Bioepis Co., Ltd.1None listedCurrent release
761424Osvyrti, Jubereqdenosumab-desuAccord BioPharma Inc.2None listedCurrent release
761420Avtozmatocilizumab-anohCELLTRION, Inc.5None listedCurrent release
761419Starjemzaustekinumab-hmnyBio-Thera Solutions, Ltd.4None listedCurrent release
761416Ziiherazanidatamab-hriiJazz Pharmaceuticals Ireland Limited1None listedCurrent release
761412Langlarainsulin glargine-aldySunshine Lake Pharma Co., Ltd.1None listedCurrent release
761411Niktimvoaxatilimab-csfrIncyte Corporation1None listedCurrent release
761406Yesintekustekinumab-kfceBiocon Biologics Inc.4None listedCurrent release
761404Stoboclo, Osenveltdenosumab-bmwoCELLTRION, Inc.2None listedCurrent release
761400Lynozyficlinvoseltamab-gcptRegeneron Pharmaceuticals, Inc.2None listedCurrent release
761399Omlycloomalizumab-igecCELLTRION, Inc.3None listedCurrent release
761398Conexxence, Bomyntradenosumab-bnhtFresenius Kabi USA, LLC3None listedCurrent release
761394Datrowaydatopotamab deruxtecan-dlnkDaiichi Sankyo, Inc1None listedCurrent release
761392Ospomyv, Xbrykdenosumab-dssbSamsung Bioepis Co., Ltd.2None listedCurrent release
761390Nemluvionemolizumab-iltoGalderma Laboratories, L.P.1None listedCurrent release
761388Piaskycrovalimab-akkzGenentech, Inc.1None listedCurrent release
761385Ponlimsidenosumab-adetTeva Pharmaceuticals, Inc.1None listedCurrent release
761384Emrelistelisotuzumab vedotin-tllvAbbVie Inc.2None listedCurrent release
761382Enzeevuaflibercept-abzvSandoz Inc.2None listedCurrent release
761381Opdivo Qvantignivolumab and hyaluronidase-nvhyBristol-Myers Squibb Company2None listedCurrent release
761379Otulfiustekinumab-aauzFresenius Kabi USA, LLC4None listedCurrent release
761378Ahzantiveaflibercept-mrbbFormycon AG2None listedCurrent release
761377Eydenzeltaflibercept-boavCELLTRION, Inc.2None listedCurrent release
761375Leqembi IQLIKlecanemab-irmbEisai, Incorporated1None listedCurrent release
761373Pyzchivaustekinumab-ttweSamsung Bioepis Co., Ltd.5None listedCurrent release
761371Ocrevus Zunovoocrelizumab and hyaluronidase-ocsqGenentech, Inc.1None listedCurrent release
761369Hympavzimarstacimab-hncqPfizer Inc.4None listedCurrent release
761367Andembrygaradacimab-gxiiCSL Behring LLC2None listedCurrent release
761365Vyloyzolbetuximab-clzbAstellas Pharma US, Inc.2None listedCurrent release
761364Imuldosaustekinumab-srlfAccord BioPharma Inc.3None listedCurrent release
761363Winrevairsotatercept-csrkMerck Sharp & Dohme LLC2None listedCurrent release
761362Jubbonti, Wyostdenosumab-bbdzSandoz Inc.2None listedCurrent release
761358Zymfentrainfliximab-dyybCELLTRION, Inc.2None listedCurrent release
761355Eylea HDafliberceptRegeneron Pharmaceuticals, Inc.1None listedCurrent release
761354Tofidencetocilizumab-baviBiogen MA Inc.3None listedCurrent release
761352Bizengrizenocutuzumab-zbcoMerus NV1None listedCurrent release
761350Opuvizaflibercept-yszySamsung Bioepis Co., Ltd.1None listedCurrent release
761349CosentyxsecukinumabNovartis Pharmaceuticals Corporation1None listedCurrent release
761347Tecentriq Hybrezaatezolizumab and hyaluronidase-tqjsGenentech, Inc.1None listedCurrent release
761346Hercessitrastuzumab-strfAccord BioPharma Inc.2None listedCurrent release
761345Elrexfioelranatamab-bcmmPfizer Inc.2None listedCurrent release
761344Imdelltratarlatamab-dlleAmgen Inc.2None listedCurrent release
761343Selarsdiustekinumab-aeknAlvotech USA Inc.4None listedCurrent release
761342Talveytalquetamab-tgvsJanssen Biotech, Inc.2None listedCurrent release
761340Epysqlieculizumab-aaghSamsung Bioepis Co., Ltd.1None listedCurrent release
761339Veopozpozelimab-bbfgRegeneron Pharmaceuticals, Inc.1None listedCurrent release
761338Steqeymaustekinumab-stbaCELLTRION, Inc.4None listedCurrent release
761336Anktivanogapendekin alfa inbakicept-pmlnAltor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.1None listedCurrent release
761334Zynyzretifanlimab-dlwrIncyte Corporation1None listedCurrent release
761333Bkemveculizumab-aeebAmgen Inc.1None listedCurrent release
761331Wezlanaustekinumab-auubAmgen Inc.1None listedCurrent release
761328Beyfortusnirsevimab-alipSanofi Vaccines US Inc.2None listedCurrent release
761326Awiqliinsulin icodec-abaeNovo Nordisk Inc.3None listedCurrent release
761325Meriloginsulin aspart-szjjSanofi-Aventis U.S. LLC2None listedCurrent release
761324Epkinlyepcoritamab-byspGenmab US, Inc.2None listedCurrent release
761322Tyrukonatalizumab-sztnSandoz Inc.1None listedCurrent release
761315Alhemoconcizumab-mtciNovo Nordisk Inc.3None listedCurrent release
761312Lymphirdenileukin diftitox-cxdlCitius Oncology, Inc.1None listedCurrent release
761310Elaheremirvetuximab soravtansine-gynxImmunoGen, Inc.1None listedCurrent release