US protection

US protection ending in 2029: Ear, nose and throat

As of the edition of 20 October 2026, 11 drugs have US protection that ends in 2029 in ear, nose and throat; 8 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
Amifampridine Ends 2029 (exclusivity)Marketed Angelini Pharma 0
Atezolizumab Ends 2029 (orphan exclusivity)Marketed Roche CD274 1
Avelumab Ends 2029 (computed from the first US licence)Marketed Merck KGaA CD274 1
Azacitidine Ends 2029 (exclusivity)Marketed Bristol Myers Squibb DNMT1, DNMT3A 4
Budesonide Ends 2029 (exclusivity)Marketed NR3C1 5
Crizotinib Ends 2029 (patent)Marketed Pfizer ALK, MET, ROS1 2
Edaravone Ends 2029 (exclusivity)Marketed Shionogi 0
Infigratinib Ends 2029 (patent)Marketed Helsinn Healthcare FGFR1, FGFR2, FGFR3 4
Lapatinib Ends 2029 (patent)Marketed Novartis EGFR 2
Nitric oxide Ends 2029 (patent)Marketed Byk-Mallinckrodt CIL GUCY1B1, GUCY1B2 4
Posaconazole Ends 2029 (exclusivity)Marketed Merck & Co. 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 2029 in ear, nose and throat

In the product

8 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.