US protection

US protection ending in 2036: Bones, joints and muscles

As of the edition of 20 October 2026, 10 drugs have US protection that ends in 2036 in bones, joints and muscles; 7 of them have at least one company on route B because of it.

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

10 drugs

DrugUS protectionStatusHolderTargetRoute B rows
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
Glasdegib Ends 2036 (patent)Marketed Pfizer SMO 1
Letibotulinumtoxina Ends 2036 (computed from the first US licence)Marketed Hugel SNAP25 1
Lifileucel Ends 2036 (reference-product exclusivity)Marketed Iovance Biotherapeutics 0
Pexidartinib Ends 2036 (patent)Marketed Daiichi Sankyo CSF1R, FLT3, KIT 0
Sonidegib Ends 2036 (patent)Marketed SUN Pharmaceutical Industries SMO 0
Sotatercept Ends 2036 (computed from the first US licence)Marketed Merck & Co. INHBA 1
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 bones, joints and muscles

In the product

7 of these 10 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.