US protection

US protection ending in 2035: Digestive system

As of the edition of 20 October 2026, 18 drugs have US protection that ends in 2035 in digestive system, 17 of them marketed; 12 of them have at least one company on route B because of it.

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

18 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Bictegravir Ends 2035 (patent)Marketed Gilead Sciences 0
Brensocatib Ends 2035 (patent)Marketed Insmed CTSC 1
Brigatinib Ends 2035 (patent)Marketed Takeda ALK, EGFR 1
Cefiderocol Ends 2035 (patent)Marketed Shionogi 0
Efbemalenograstim alfa Ends 2035 (computed from the first US licence)Marketed Evive Biotechnology CSF3R 2
Ferric maltol Ends 2035 (patent)Marketed Shield Tx 0
Fruquintinib Ends 2035 (patent)Marketed Takeda FLT1, FLT4, KDR 2
Glecaprevir Ends 2035 (patent)Marketed AbbVie 0
Lenvatinib Ends 2035 (patent)Marketed Eisai FLT1, FLT4, KDR 3
Mirikizumab Ends 2035 (computed from the first US licence)Marketed Eli Lilly IL23A 1
Pafolacianine Ends 2035 (patent)Marketed On Target FOLR1 1
Perflutren Ends 2035 (patent)Marketed Lantheus Medical Imaging 0
Pozelimab Ends 2035 (computed from the first US licence)Marketed Regeneron C5 1
Retifanlimab Ends 2035 (computed from the first US licence)Marketed Incyte PDCD1 1
Selinexor Ends 2035 (patent)Marketed Karyopharm Therapeutics XPO1 2
Tasimelteon Ends 2035 (patent)Marketed Vanda Pharmaceuticals MTNR1A, MTNR1B 2
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Umbralisib Ends 2035 (patent)Withdrawn from market TG Therapeutics ABL1, PIK3CD 0

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 digestive system

In the product

12 of these 18 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.