US protection

US protection ending in 2030: Ear, nose and throat

As of the edition of 20 October 2026, 11 drugs have US protection that ends in 2030 in ear, nose and throat; 9 of them have at least one company on route B because of it.

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

11 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Axitinib Ends 2030 (patent)Marketed Pfizer FLT1, FLT4, KDR 0
Cemiplimab Ends 2030 (computed from the first US licence)Marketed Regeneron PDCD1 2
Dabrafenib Ends 2030 (patent)Marketed Novartis BRAF 1
Doxecitine Ends 2030 (exclusivity)Marketed UCB 0
Erenumab Ends 2030 (computed from the first US licence)Marketed Amgen CALCRL 1
Fremanezumab Ends 2030 (computed from the first US licence)Marketed Teva CALCA, CALCB 4
Galcanezumab Ends 2030 (computed from the first US licence)Marketed Eli Lilly CALCA, CALCB 2
Neratinib Ends 2030 (patent)Marketed Puma Biotechnology EGFR 2
Sildenafil Ends 2030 (exclusivity)Marketed Viatris PDE5A 3
Trametinib Ends 2030 (patent)Marketed Novartis MAP2K1, MAP2K2 2
Vemurafenib Ends 2030 (patent)Marketed Roche BRAF 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 2030 in ear, nose and throat

In the product

9 of these 11 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.