US protection

US protection ending in 2032

As of the edition of 20 October 2026, 63 drugs have US protection that ends in 2032; 38 of them have at least one company on route B because of it.

Sources: FDA Orange Book and Purple Book, other approval registers.

63 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Ansuvimab Ends 2032 (computed from the first US licence)Marketed Emergent Biosolutions 0
Atoltivimab Ends 2032 (computed from the first US licence)Marketed Regeneron 0
Avatrombopag Ends 2032 (exclusivity)Marketed Akarx MPL 2
Avutometinib Ends 2032 (exclusivity)Marketed Verastem MAP2K1, MAP2K2 1
Baricitinib Ends 2032 (patent)Marketed Eli Lilly JAK1, JAK2 4
Belantamab mafodotin Ends 2032 (computed from the first US licence)Marketed GSK TNFRSF17, TUBB, TUBB1 8
Bexagliflozin Ends 2032 (patent)Marketed Theracosbio SLC5A2 1
Brexucabtagene autoleucel Ends 2032 (computed from the first US licence)Marketed Gilead Sciences CD19 0
Cabozantinib Ends 2032 (exclusivity)Marketed Exelixis KDR 2
Capmatinib Ends 2032 (patent)Marketed Novartis MET 1
Cenobamate Ends 2032 (patent)Marketed SK Life Science SCN10A, SCN11A, SCN1A 0
Ceritinib Ends 2032 (patent)Marketed Novartis ALK 1
Cobicistat Ends 2032 (patent)Marketed Gilead Sciences 0
Copanlisib Ends 2032 (patent)Marketed Bayer PIK3CA, PIK3CD 2
Dacomitinib anhydrous Ends 2032 (patent)Marketed Pfizer EGFR 1
Dasabuvir Ends 2032 (patent)Marketed AbbVie 0
Defatted powder of arachis hypogaea l., semen (peanuts) Ends 2032 (computed from the first US licence)Marketed Greer 0
Difelikefalin Ends 2032 (patent)Marketed CSL Behring OPRK1 2
Doravirine Ends 2032 (patent)Marketed Merck & Co. 0
Dordaviprone Ends 2032 (exclusivity)Marketed Chimerix CLPP, DRD2 2
Duvelisib Ends 2032 (patent)Marketed Secura Bio PIK3CD, PIK3CG 2
Eculizumab Ends 2032 (orphan exclusivity)Marketed AstraZeneca C5 0
Elamipretide Ends 2032 (exclusivity)Marketed Stealth BioTherapeutics 0
Emtricitabine Ends 2032 (patent)Marketed Gilead Sciences 0
Eptinezumab Ends 2032 (computed from the first US licence)Marketed Lundbeck CALCA, CALCB 2
Estradiol Ends 2032 (patent)Marketed ESR1 6
Flortaucipir Ends 2032 (patent)Marketed Avid Radiopharmaceuticals MAPT 2
Fosnetupitant Ends 2032 (patent)Marketed Helsinn Healthcare TACR1 0
Gilteritinib Ends 2032 (patent)Marketed Astellas AXL, FLT3 2
Golimumab Ends 2032 (orphan exclusivity)Marketed Johnson & Johnson TNF 0
Inebilizumab Ends 2032 (computed from the first US licence)Marketed Amgen CD19 1
Isatuximab Ends 2032 (computed from the first US licence)Marketed Sanofi CD38 1
Leniolisib Ends 2032 (patent)Marketed Pharming Technologies PIK3CD 1
Lesinurad Ends 2032 (patent)Marketed Ironwood Pharmaceuticals SLC22A12 1
Levomilnacipran Ends 2032 (patent)Marketed AbbVie SLC6A2 1
Margetuximab Ends 2032 (computed from the first US licence)Marketed MacroGenics ERBB2 1
Moxidectin Ends 2032 (exclusivity)Marketed Medicines Development For Global Health 0
Naloxegol Ends 2032 (patent)Marketed Averitas Pharma OPRM1 3
Naxitamab Ends 2032 (computed from the first US licence)Marketed Y-mAbs Therapeutics 0
Neisseria meningitidis polysaccharide conjugated to tetanus toxoid Ends 2032 (reference-product exclusivity)Marketed Sanofi 0
Nerandomilast Ends 2032 (exclusivity)Marketed Boehringer Ingelheim PDE4B 1
Nilotinib Ends 2032 (patent)Marketed Novartis ABL1 0
Odesivimab Ends 2032 (computed from the first US licence)Marketed Regeneron 0
Oliceridine Ends 2032 (patent)Marketed Trevena OPRM1 1
Ombitasvir Ends 2032 (patent)Marketed AbbVie 0
Opicapone Ends 2032 (patent)Marketed Amneal Pharmaceuticals COMT 2
Osimertinib Ends 2032 (patent)Marketed AstraZeneca EGFR 0
Plazomicin Ends 2032 (patent)Marketed Cipla 0
Ponesimod Ends 2032 (patent)Marketed Vanda Pharmaceuticals S1PR1 2
Regorafenib Ends 2032 (patent)Marketed Bayer BRAF, FGFR1, FGFR2 8
Sacituzumab govitecan Ends 2032 (computed from the first US licence)Marketed Gilead Sciences TACSTD2, TOP1 2
Satralizumab Ends 2032 (computed from the first US licence)Marketed Roche IL6R, IL6ST 0
Selumetinib Ends 2032 (exclusivity)Marketed AstraZeneca MAP2K1, MAP2K2 4
Setmelanotide Ends 2032 (patent)Marketed Rhythm Pharmaceuticals MC4R 1
Somapacitan Ends 2032 (computed from the first US licence)Marketed Novo Nordisk GHR 1
Tafasitamab Ends 2032 (computed from the first US licence)Marketed Incyte CD19 1
Tenofovir alafenamide Ends 2032 (patent)Marketed Gilead Sciences 0
Teprotumumab Ends 2032 (computed from the first US licence)Marketed Amgen IGF1R 1
Treosulfan Ends 2032 (exclusivity)Marketed Medexus Pharma 0
Venetoclax Ends 2032 (patent)Marketed AbbVie BCL2 1
Vericiguat Ends 2032 (patent)Marketed Merck & Co. GUCY1A1, GUCY1A2, GUCY1B1 3
Vonicog alfa Ends 2032 (orphan exclusivity)Marketed Takeda 0
Vonoprazan Ends 2032 (exclusivity)Marketed Phathom Pharmaceuticals ATP4A, ATP4B 1

Listed by name. A route B row is one company at one target; for a drug with one target that is the number of companies. US protection is the US only, and it is not the date generics or biosimilars can enter.

Which companies are on route B in 2032

In the product

38 of these 63 drugs have at least one company on route B. Which companies, and their scores, are in the product.

Get this list with the companies, scores and sources as a fileRequest access. Nothing is shown until you do.

US protection movers, once a month

The drugs that entered or left the two-year window in the latest edition. An email, not an account: it gives no access to the product.