US protection

US protection ending in 2036: Hormones

As of the edition of 20 October 2026, 16 drugs have US protection that ends in 2036 in hormones; 10 of them have at least one company on route B because of it.

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

16 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Abrocitinib Ends 2036 (patent)Marketed Pfizer JAK1 0
Acalabrutinib Ends 2036 (patent)Marketed AstraZeneca BTK 1
Cobimetinib Ends 2036 (patent)Marketed Roche MAP2K1 1
Futibatinib Ends 2036 (patent)Marketed Taiho FGFR1, FGFR2, FGFR3 4
Larotrectinib Ends 2036 (patent)Marketed Bayer NTRK1, NTRK2, NTRK3 3
Lifileucel Ends 2036 (reference-product exclusivity)Marketed Iovance Biotherapeutics 0
Nogapendekin alfa inbakicept Ends 2036 (computed from the first US licence)Marketed Altor BioScience IL15RA, IL2RB, IL2RG 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
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
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
Zolbetuximab Ends 2036 (computed from the first US licence)Marketed Astellas CLDN18 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 2036 in hormones

In the product

10 of these 16 drugs have at least one company on route B. Which companies, and their scores, are in the product.

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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.