FDA Purple BookSynced 9 d agoSource month · April 2026
FDA Purple Book: search biologics, biosimilars, interchangeables, and biologic patents
Track originator exclusivity, see which biosimilars are queued behind every reference product, and watch patent cliffs as they approach — directly from official FDA Purple Book records.
841
Licensed products
across 2,182 presentations
48
Biosimilars
43
Interchangeables
424
Listed patents
Recently licensed FDA biologics and biosimilars
The most recently licensed biological products in the FDA Purple Book, sourced from official FDA records with reference-product, license-type, and exclusivity context.
Showing 48 FDA-licensed biological products, including 32 reference biologics, 3 biosimilars, and 13 interchangeables.
| Product | Proper name | Applicant | Type | BLA | Approved | Exclusivity ends | Copy |
|---|---|---|---|---|---|---|---|
| Saphnelo | anifrolumab-fnia· 2 presentations | AstraZeneca AB | 351(a) | 761451 | — | ||
| OTARMENI | lunsotogene parvec-cwha | Regeneron Pharmaceuticals, Inc. | 351(a) | 125874 | — | ||
| Thrombin-Jmi, Thrombocoll | Thrombin, Topical (Bovine)· 4 presentations | GenTrac, Inc. | 351(a) | 102865 | — | ||
| Ponlimsi | denosumab-adet | Teva Pharmaceuticals, Inc. | 351(k) Interchangeable | 761385 | — | ||
| Awiqli | insulin icodec-abae· 3 presentations | Novo Nordisk Inc. | 351(a) | 761326 | — | ||
| kresladi | marnetegragene autotemcel | Rocket Pharmaceuticals Inc | 351(a) | 125806 | — | ||
| Avlayah | tividenofusp alfa-eknm | Denali Therapeutics Inc. | 351(a) | 761485 | — | ||
| Loargys | pegzilarginase-nbln· 2 presentations | Immedica Pharma AB | 351(a) | 761211 | — | ||
| Rybrevant Faspro | amivantamab and hyaluronidase-lpuj· 4 presentations | Janssen Biotech, Inc. | 351(a) | 761484 | — | ||
| Yesafili | aflibercept-jbvf· 2 presentations | Biocon Biologics Inc. | 351(k) Biosimilar | 761274 | — | ||
| Yartemlea | narsoplimab-wuug | Omeros Corporation | 351(a) | 761152 | — | ||
| Oziltus | denosumab-mobz | Amneal Pharmaceuticals LLC | 351(k) Interchangeable | 761457 | — | ||
| Boncresa | denosumab-mobz | Amneal Pharmaceuticals LLC | 351(k) Interchangeable | 761456 | — | ||
| Lunsumio Velo | mosunetuzumab-axgb· 4 presentations | Genentech, Inc. | 351(a) | 761263 | |||
| Nufymco | ranibizumab-leyk· 2 presentations | Formycon AG | 351(k) Interchangeable | 761473 | — | ||
| Exdensur | depemokimab-ulaa· 2 presentations | GlaxoSmithKline LLC | 351(a) | 761458 | — | ||
| FESILTY | fibrinogen, human�chmt | Grifols Therapeutics LLC | 351(a) | 125833 | — | ||
| Lerochol | lerodalcibep-liga | LIB Therapeutics, Inc. | 351(a) | 761427 | — | ||
| waskyra | etuvetidigene autotemcel | Fondazione Telethon Ets | 351(a) | 125846 | — | ||
| avance nerve graft | acellular nerve allograft-arwx | Axogen Corporation | 351(a) | 125816 | — | ||
| Omlyclo | omalizumab-igec· 3 presentations | CELLTRION, Inc. | 351(k) Interchangeable | 761399 | — | ||
| Armlupeg | pegfilgrastim-unne | Lupin Limited (Biotech Division) | 351(k) Biosimilar | 761212 | — | ||
| Voyxact | sibeprenlimab-szsi | Otsuka Pharmaceutical Company, Ltd. | 351(a) | 761434 | — | ||
| Opdivo Qvantig | nivolumab and hyaluronidase-nvhy· 2 presentations | Bristol-Myers Squibb Company | 351(a) | 761381 | — | ||
| ITVISMA | onasemnogene abeparvovec-brve | Novartis Gene Therapies, Inc. | 351(a) | 125856 | — | ||
| Poherdy | pertuzumab-dpzb | Shanghai Henlius Biotech, Inc. | 351(k) Interchangeable | 761450 | — | ||
| Jubereq | denosumab-desu· 2 presentations | Accord BioPharma Inc. | 351(k) Interchangeable | 761424 | — | ||
| Blenrep | belantamab mafodotin-blmf | GlaxoSmithKline LLC | 351(a) | 761440 | — | ||
| Eydenzelt | aflibercept-boav· 2 presentations | CELLTRION, Inc. | 351(k) Biosimilar | 761377 | — | ||
| QIVIGY | Immune Globulin Intravenous, Human-kthm, 10% Solution· 2 presentations | Kedrion, S.p.A. | 351(a) | 125822 | — | ||
| Enoby | denosumab-qbde· 2 presentations | Hikma Pharmaceuticals USA Inc. | 351(k) Interchangeable | 761439 | — | ||
| Keytruda Qlex | pembrolizumab and berahyaluronidase alfa-pmph· 2 presentations | Merck Sharp & Dohme LLC | 351(a) | 761467 | — | ||
| Bosaya | denosumab-kyqq· 2 presentations | Biocon Biologics Inc. | 351(k) Interchangeable | 761436 | — | ||
| Skyrizi | risankizumab-rzaa· 7 presentations | AbbVie Inc. | 351(a) | 761105 | — | ||
| Bilprevda | denosumab-nxxp· 3 presentations | Shanghai Henlius Biotech, Inc. | 351(k) Interchangeable | 761444 | — | ||
| Leqembi IQLIK | lecanemab-irmb | Eisai, Incorporated | 351(a) | 761375 | — | ||
| Krystexxa | pegloticase· 2 presentations | Horizon Therapeutics Ireland DAC | 351(a) | 125293 | |||
| Comirnaty | COVID-19 Vaccine, mRNA· 6 presentations | BioNTech Manufacturing GmbH | 351(a) | 125742 | — | ||
| PAPZIMEOS | zopapogene imadenovec-drba | Precigen, Inc. | 351(a) | 125832 | — | ||
| Skytrofa | lonapegsomatropin-tcgd· 14 presentations | Ascendis Pharma Endocrinology Division A/S | 351(a) | 761177 | — | ||
| Shingrix | Zoster Vaccine Recombinant, Adjuvanted· 3 presentations | GlaxoSmithKline Biologicals | 351(a) | 125614 | — | ||
| Kirsty | insulin aspart-xjhz· 2 presentations | Biocon Biologics Inc. | 351(k) Interchangeable | 761188 | — | ||
| Spikevax | COVID-19 Vaccine, mRNA· 5 presentations | ModernaTX, Inc. | 351(a) | 125752 | — | ||
| Lynozyfic | linvoseltamab-gcpt· 2 presentations | Regeneron Pharmaceuticals, Inc. | 351(a) | 761400 | — | ||
| Pyzchiva | ustekinumab-ttwe· 5 presentations | Samsung Bioepis Co., Ltd. | 351(k) Interchangeable | 761373 | — | ||
| Andembry | garadacimab-gxii· 2 presentations | CSL Behring LLC | 351(a) | 761367 | — | ||
| Steqeyma | ustekinumab-stba· 4 presentations | CELLTRION, Inc. | 351(k) Interchangeable | 761338 | — | ||
| Enflonsia | clesrovimab-cfor | Merck Sharp & Dohme LLC | 351(a) | 761432 | — |
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