US protection

US protection ending in 2026: Digestive system

As of the edition of 20 October 2026, 20 drugs have US protection that ends (or has ended) in 2026 in digestive system; 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
Afamelanotide Ended 2026 (exclusivity)Marketed Clinuvel MC1R 1
Belinostat Ended 2026 (patent)Marketed Acrotech Biopharma 0
Darunavir Ends 2026 (patent)Marketed Johnson & Johnson 0
Dasatinib anhydrous Ended 2026 (exclusivity)Marketed ABL1, BLK, FGR 12
Dulaglutide Ended 2026 (computed from the first US licence)Marketed Eli Lilly GLP1R 0
Elvitegravir Ends 2026 (patent)Marketed Gilead Sciences 0
Eribulin Ended 2026 (exclusivity)Marketed Eisai TUBB, TUBB1, TUBB2A 9
Escitalopram Ended 2026 (exclusivity)Marketed AbbVie SLC6A4 4
Lacosamide Ended 2026 (exclusivity)Marketed UCB SCN10A, SCN11A, SCN1A 0
Linagliptin Ends 2026 (exclusivity)Marketed Boehringer Ingelheim DPP4 1
Metreleptin Ended 2026 (computed from the first US licence)Marketed Chiesi Farmaceutici LEPR 0
Onabotulinumtoxina Ended 2026 (orphan exclusivity)Marketed AbbVie SNAP25 0
Pasireotide Ends 2026 (patent)Marketed Recordati Rare Diseases SSTR2, SSTR3, SSTR5 0
Ramucirumab Ended 2026 (orphan exclusivity)Marketed Eli Lilly KDR 1
Siltuximab Ended 2026 (computed from the first US licence)Marketed Recordati Rare Diseases IL6 2
Sitagliptin Ends 2026 (patent)Marketed Merck & Co. DPP4 1
Teduglutide Ended 2026 (exclusivity)Marketed Takeda GLP2R 1
Tolvaptan Ended 2026 (patent)Marketed Otsuka AVPR2 0
Triclabendazole Ended 2026 (exclusivity)Marketed Novartis 0
Vedolizumab Ended 2026 (computed from the first US licence)Marketed Takeda ITGA4 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 2026 in digestive system

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.