US protection

US protection ending in 2036: Lungs and airways

As of the edition of 20 October 2026, 23 drugs have US protection that ends in 2036 in lungs and airways; 16 of them have at least one company on route B because of it.

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

23 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
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
Lifileucel Ends 2036 (reference-product exclusivity)Marketed Iovance Biotherapeutics 0
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
Oteseconazole Ends 2036 (patent)Marketed Mycovia Pharmaceuticals 0
Pexidartinib Ends 2036 (patent)Marketed Daiichi Sankyo CSF1R, FLT3, KIT 0
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
Tarlatamab Ends 2036 (computed from the first US licence)Marketed Amgen CD3D, CD3E, CD3G 1
Tislelizumab Ends 2036 (computed from the first US licence)Marketed BeiGene PDCD1 2
Upadacitinib Ends 2036 (patent)Marketed AbbVie JAK1, JAK2, JAK3 3
Zanidatamab Ends 2036 (computed from the first US licence)Marketed Jazz Pharmaceuticals ERBB2 1
Zenocutuzumab Ends 2036 (computed from the first US licence)Marketed Merus ERBB2, ERBB3 2

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 lungs and airways

In the product

16 of these 23 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.