US protection

US protection ending in 2027: Ear, nose and throat

As of the edition of 20 October 2026, 9 drugs have US protection that ends in 2027 in ear, nose and throat; 6 of them have at least one company on route B because of it.

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

9 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Anakinra Ends 2027 (orphan exclusivity)Marketed Swedish Orphan Biovitrum IL1R1 0
Bevacizumab Ends 2027 (orphan exclusivity)Marketed Roche VEGFA 2
Fluticasone furoate Ends 2027 (patent)Marketed GSK NR3C1 0
Ipilimumab Ends 2027 (orphan exclusivity)Marketed Bristol Myers Squibb CTLA4 1
Mepolizumab Ends 2027 (computed from the first US licence)Marketed GSK IL5 0
Nintedanib Ends 2027 (exclusivity)Marketed Boehringer Ingelheim FGFR1, FGFR2, FGFR3 9
Pantoprazole Ends 2027 (exclusivity)Marketed Pfizer ATP4A 1
Sorafenib Ends 2027 (patent)Marketed Bayer BRAF, FLT1, FLT3 1
Vorinostat Ends 2027 (patent)Marketed Merck & Co. HDAC1, HDAC2, HDAC3 4

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 2027 in ear, nose and throat

In the product

6 of these 9 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.