US protection

US protection ending in 2026: Immune system

As of the edition of 20 October 2026, 24 drugs have US protection that ends (or has ended) in 2026 in immune system; 12 of them have at least one company on route B because of it.

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

24 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Afamelanotide Ended 2026 (exclusivity)Marketed Clinuvel MC1R 1
Albiglutide Ended 2026 (computed from the first US licence)Marketed GSK GLP1R 1
Belinostat Ended 2026 (patent)Marketed Acrotech Biopharma 0
Conestat alfa Ended 2026 (reference-product exclusivity)Marketed Pharming Americas BV 0
Darunavir Ends 2026 (patent)Marketed Johnson & Johnson 0
Dasatinib anhydrous Ended 2026 (exclusivity)Marketed ABL1, BLK, FGR 12
Deflazacort Ended 2026 (exclusivity)Marketed PTC Therapeutics NR3C1 0
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
Ivabradine Ends 2026 (patent)Marketed Amgen HCN4 3
Lacosamide Ended 2026 (exclusivity)Marketed UCB SCN10A, SCN11A, SCN1A 0
Leuprolide Ended 2026 (exclusivity)Marketed GNRHR 1
Metreleptin Ended 2026 (computed from the first US licence)Marketed Chiesi Farmaceutici LEPR 0
Neisseria meningitidis factor h binding protein Ends 2026 (reference-product exclusivity)Marketed Pfizer 0
Onabotulinumtoxina Ended 2026 (orphan exclusivity)Marketed AbbVie SNAP25 0
Pasireotide Ends 2026 (patent)Marketed Recordati Rare Diseases SSTR2, SSTR3, SSTR5 0
Peginterferon beta-1a Ended 2026 (computed from the first US licence)Marketed Biogen IFNAR1, IFNAR2 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
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 immune system

In the product

12 of these 24 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.