US protection

US protection ending in 2035: Immune system

As of the edition of 20 October 2026, 27 drugs have US protection that ends in 2035 in immune system, 26 of them marketed; 14 of them have at least one company on route B because of it.

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

27 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Bictegravir Ends 2035 (patent)Marketed Gilead Sciences 0
Bimekizumab Ends 2035 (computed from the first US licence)Marketed UCB IL17A, IL17F 2
Brigatinib Ends 2035 (patent)Marketed Takeda ALK, EGFR 1
Danicopan Ends 2035 (patent)Marketed AstraZeneca CFD 1
Donislecel Ends 2035 (computed from the first US licence)Marketed CellTrans 0
Efanesoctocog alfa Ends 2035 (computed from the first US licence)Marketed Bioverativ Therapeutics 0
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
Finerenone Ends 2035 (patent)Marketed Bayer NR3C2 0
Florquinitau Ends 2035 (patent)Marketed CERVEAU TECHNOLOGIES INC A LANTHEUS CO MAPT 0
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
Omidubicel Ends 2035 (computed from the first US licence)Marketed Gamida Cell 0
Perflutren Ends 2035 (patent)Marketed Lantheus Medical Imaging 0
Pozelimab Ends 2035 (computed from the first US licence)Marketed Regeneron C5 1
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
Rozanolixizumab Ends 2035 (computed from the first US licence)Marketed UCB FCGRT 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
Umbralisib Ends 2035 (patent)Withdrawn from market TG Therapeutics ABL1, PIK3CD 0
Zilucoplan sodium Ends 2035 (patent)Marketed UCB C5 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 2035 in immune system

In the product

14 of these 27 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.