US protection

US protection ending in 2035: Infections

As of the edition of 20 October 2026, 23 drugs have US protection that ends in 2035 in infections; 11 of them have at least one company on route B because of it.

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

23 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Bacillus anthracis protective antigen, adsorbed Ends 2035 (computed from the first US licence)Marketed Emergent Product Development Gaithersburg, Inc. 0
Bictegravir Ends 2035 (patent)Marketed Gilead Sciences 0
Bimekizumab Ends 2035 (computed from the first US licence)Marketed UCB IL17A, IL17F 2
Brensocatib Ends 2035 (patent)Marketed Insmed CTSC 1
Cefiderocol Ends 2035 (patent)Marketed Shionogi 0
Chikungunya virus, live attenuated Ends 2035 (computed from the first US licence)Marketed Valneva 0
Danicopan Ends 2035 (patent)Marketed AstraZeneca CFD 1
Elranatamab Ends 2035 (computed from the first US licence)Marketed Pfizer CD3E, TNFRSF17 1
Epcoritamab Ends 2035 (computed from the first US licence)Marketed Merus CD3D, CD3E, CD3G 2
Fruquintinib Ends 2035 (patent)Marketed Takeda FLT1, FLT4, KDR 2
Glecaprevir Ends 2035 (patent)Marketed AbbVie 0
Glofitamab Ends 2035 (computed from the first US licence)Marketed Roche CD3E, MS4A1 0
Ibrexafungerp Ends 2035 (patent)Marketed GSK 0
Lenvatinib Ends 2035 (patent)Marketed Eisai FLT1, FLT4, KDR 3
Nirsevimab Ends 2035 (computed from the first US licence)Marketed Sanofi 0
Oritavancin Ends 2035 (patent)Marketed Melinta Therapeutics 0
Remdesivir Ends 2035 (patent)Marketed Gilead Sciences 0
Respiratory syncytial virus pre-fusion glycoprotein f Ends 2035 (reference-product exclusivity)Marketed GSK 0
Retifanlimab Ends 2035 (computed from the first US licence)Marketed Incyte PDCD1 1
Selinexor Ends 2035 (patent)Marketed Karyopharm Therapeutics XPO1 2
Talquetamab Ends 2035 (computed from the first US licence)Marketed Johnson & Johnson CD3D, CD3E, CD3G 1
Toripalimab Ends 2035 (computed from the first US licence)Marketed Coherus Oncology PDCD1 2
Zoliflodacin Ends 2035 (exclusivity)Marketed Entasis Therapeutics 0

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 2035 in infections

In the product

11 of these 23 drugs have at least one company on route B. Which companies, and their scores, are in the product.

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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.