US protection

US protection ending in 2031: Bones, joints and muscles

As of the edition of 20 October 2026, 15 drugs have US protection that ends in 2031 in bones, joints and muscles; 9 of them have at least one company on route B because of it.

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

15 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Alectinib Ends 2031 (patent)Marketed Roche ALK, RET 1
Blinatumomab Ends 2031 (orphan exclusivity)Marketed Amgen CD19, CD3D, CD3E 0
Cipepofol Ends 2031 (exclusivity)Marketed Haisco-USA Pharmaceuticals 0
Delafloxacin Ends 2031 (patent)Marketed Melinta Therapeutics 0
Dolutegravir Ends 2031 (patent)Marketed GSK 0
Etelcalcetide Ends 2031 (patent)Marketed Amgen CASR 1
Fostamatinib Ends 2031 (patent)Marketed Rigel Pharmaceuticals SYK 3
Letrozole Ends 2031 (patent)Marketed Novartis CYP19A1 1
Nivolumab Ends 2031 (orphan exclusivity)Marketed Bristol Myers Squibb PDCD1 2
Onasemnogene abeparvovec Ends 2031 (reference-product exclusivity)Marketed Novartis 0
Pembrolizumab Ends 2031 (orphan exclusivity)Marketed Merck & Co. PDCD1 1
Prabotulinumtoxin a Ends 2031 (computed from the first US licence)Marketed Evolus SNAP25 0
Ribociclib Ends 2031 (patent)Marketed Novartis CDK4, CDK6 2
Risankizumab Ends 2031 (computed from the first US licence)Marketed AbbVie IL23A 1
Romosozumab Ends 2031 (computed from the first US licence)Marketed Amgen SOST 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 2031 in bones, joints and muscles

In the product

9 of these 15 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.