US protection

US protection ending in 2036: Immune system

As of the edition of 20 October 2026, 24 drugs have US protection that ends in 2036 in immune system; 18 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
Abrocitinib Ends 2036 (patent)Marketed Pfizer JAK1 0
Acalabrutinib Ends 2036 (patent)Marketed AstraZeneca BTK 1
Axatilimab Ends 2036 (computed from the first US licence)Marketed Incyte CSF1R 1
Cobimetinib Ends 2036 (patent)Marketed Roche MAP2K1 1
Cosibelimab Ends 2036 (computed from the first US licence)Marketed SUN Pharmaceutical Industries CD274 1
Crovalimab Ends 2036 (computed from the first US licence)Marketed Roche C5 1
Difamilast Ends 2036 (patent)Marketed Acrotech Biopharma PDE4A, PDE4B, PDE4C 4
Etrasimod Ends 2036 (patent)Marketed Pfizer S1PR1 1
Futibatinib Ends 2036 (patent)Marketed Taiho FGFR1, FGFR2, FGFR3 4
Glasdegib Ends 2036 (patent)Marketed Pfizer SMO 1
Larotrectinib Ends 2036 (patent)Marketed Bayer NTRK1, NTRK2, NTRK3 3
Lebrikizumab Ends 2036 (computed from the first US licence)Marketed Eli Lilly IL13 1
Nemolizumab Ends 2036 (computed from the first US licence)Marketed Galderma IL31RA 2
Nogapendekin alfa inbakicept Ends 2036 (computed from the first US licence)Marketed Altor BioScience IL15RA, IL2RB, IL2RG 0
Obecabtagene autoleucel Ends 2036 (reference-product exclusivity)Marketed Autolus CD19 1
Oteseconazole Ends 2036 (patent)Marketed Mycovia Pharmaceuticals 0
Pexidartinib Ends 2036 (patent)Marketed Daiichi Sankyo CSF1R, FLT3, KIT 0
Pirtobrutinib Ends 2036 (patent)Marketed Eli Lilly BTK 1
Remestemcel-l Ends 2036 (computed from the first US licence)Marketed Mesoblast 0
Repotrectinib Ends 2036 (patent)Marketed Bristol Myers Squibb NTRK2, NTRK3, ROS1 3
Sonidegib Ends 2036 (patent)Marketed SUN Pharmaceutical Industries SMO 0
Sotatercept Ends 2036 (computed from the first US licence)Marketed Merck & Co. INHBA 1
Tislelizumab Ends 2036 (computed from the first US licence)Marketed BeiGene PDCD1 2
Upadacitinib Ends 2036 (patent)Marketed AbbVie JAK1, JAK2, JAK3 3

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 2036 in immune system

In the product

18 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.