US protection

US protection ending in 2030: Digestive system

As of the edition of 20 October 2026, 19 drugs have US protection that ends in 2030 in digestive system; 14 of them have at least one company on route B because of it.

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

19 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Aflibercept Ends 2030 (orphan exclusivity)Marketed Regeneron PGF, VEGFA 4
Axitinib Ends 2030 (patent)Marketed Pfizer FLT1, FLT4, KDR 0
Calaspargase pegol Ends 2030 (computed from the first US licence)Marketed Servier 0
Cemiplimab Ends 2030 (computed from the first US licence)Marketed Regeneron PDCD1 2
Dabrafenib Ends 2030 (patent)Marketed Novartis BRAF 1
Doxecitine Ends 2030 (exclusivity)Marketed UCB 0
Eliglustat Ends 2030 (patent)Marketed Sanofi UGCG 1
Emapalumab Ends 2030 (computed from the first US licence)Marketed Swedish Orphan Biovitrum IFNG 1
Encorafenib Ends 2030 (exclusivity)Marketed Pfizer BRAF 3
Mogamulizumab Ends 2030 (computed from the first US licence)Marketed Kyowa Kirin CCR4 1
Neratinib Ends 2030 (patent)Marketed Puma Biotechnology EGFR 2
Omadacycline Ends 2030 (patent)Marketed Transcept Pharmaceuticals 0
Pacritinib Ends 2030 (patent)Marketed Swedish Orphan Biovitrum FLT3, JAK2 2
Raltegravir Ends 2030 (patent)Marketed Merck & Co. 0
Sildenafil Ends 2030 (exclusivity)Marketed Viatris PDE5A 3
Tepotinib Ends 2030 (patent)Marketed Merck KGaA MET 1
Tradipitant Ends 2030 (exclusivity)Marketed Vanda Pharmaceuticals TACR1 1
Trametinib Ends 2030 (patent)Marketed Novartis MAP2K1, MAP2K2 2
Vemurafenib Ends 2030 (patent)Marketed Roche BRAF 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 2030 in digestive system

In the product

14 of these 19 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.