US protection

US protection ending in 2035: Nutrition and metabolism

As of the edition of 20 October 2026, 20 drugs have US protection that ends in 2035 in nutrition and metabolism; 10 of them have at least one company on route B because of it.

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

20 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Bictegravir Ends 2035 (patent)Marketed Gilead Sciences 0
Cipaglucosidase alfa Ends 2035 (computed from the first US licence)Marketed Amicus Therapeutics IGF2R 1
Donislecel Ends 2035 (computed from the first US licence)Marketed CellTrans 0
Elranatamab Ends 2035 (computed from the first US licence)Marketed Pfizer CD3E, TNFRSF17 1
Exagamglogene autotemcel Ends 2035 (computed from the first US licence)Marketed Vertex BCL11A 1
Ferric maltol Ends 2035 (patent)Marketed Shield Tx 0
Finerenone Ends 2035 (patent)Marketed Bayer NR3C2 0
Florquinitau Ends 2035 (patent)Marketed CERVEAU TECHNOLOGIES INC A LANTHEUS CO MAPT 0
Mirikizumab Ends 2035 (computed from the first US licence)Marketed Eli Lilly IL23A 1
Pegunigalsidase alfa Ends 2035 (computed from the first US licence)Marketed Chiesi Farmaceutici 0
Perflutren Ends 2035 (patent)Marketed Lantheus Medical Imaging 0
Remdesivir Ends 2035 (patent)Marketed Gilead Sciences 0
Selinexor Ends 2035 (patent)Marketed Karyopharm Therapeutics XPO1 2
Sodium zirconium cyclosilicate Ends 2035 (patent)Marketed AstraZeneca 0
Tafamidis Ends 2035 (patent)Marketed Pfizer TTR 1
Talquetamab Ends 2035 (computed from the first US licence)Marketed Johnson & Johnson CD3D, CD3E, CD3G 1
Tofersen Ends 2035 (patent)Marketed Biogen SOD1 1
Toripalimab Ends 2035 (computed from the first US licence)Marketed Coherus Oncology PDCD1 2
Velmanase alfa Ends 2035 (computed from the first US licence)Marketed Chiesi Farmaceutici 0
Vosoritide Ends 2035 (patent)Marketed Amicus Therapeutics NPR2 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 nutrition and metabolism

In the product

10 of these 20 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.