US protection

US protection ending in 2033: Bones, joints and muscles

As of the edition of 20 October 2026, 10 drugs have US protection that ends in 2033 in bones, joints and muscles; 8 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
Alpelisib Ends 2033 (patent)Marketed Novartis PIK3CA 1
Anifrolumab Ends 2033 (computed from the first US licence)Marketed AstraZeneca IFNAR1 1
Binimetinib Ends 2033 (patent)Marketed Pfizer MAP2K1, MAP2K2 6
Cravacitinib Ends 2033 (patent)Marketed Bristol Myers Squibb TYK2 1
Efgartigimod alfa Ends 2033 (computed from the first US licence)Marketed argenx FCGRT 1
Erdafitinib Ends 2033 (patent)Marketed Johnson & Johnson FGFR1, FGFR2, FGFR3 4
Lonapegsomatropin Ends 2033 (computed from the first US licence)Marketed Ascendis Pharma A/S GHR 1
Omaveloxolone Ends 2033 (patent)Marketed Biogen NFE2L2 1
Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae crm197 Ends 2033 (reference-product exclusivity)Marketed Merck & Co. 0
Tozinameran Ends 2033 (computed from the first US licence)Marketed BioNTech Manufacturing GmbH 0

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 2033 in bones, joints and muscles

In the product

8 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.