US protection

US protection ending in 2031: Ear, nose and throat

As of the edition of 20 October 2026, 9 drugs have US protection that ends in 2031 in ear, nose and throat; 5 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
Benralizumab Ends 2031 (orphan exclusivity)Marketed AstraZeneca IL5RA 0
Brolucizumab Ends 2031 (computed from the first US licence)Marketed Novartis VEGFA 0
Cipepofol Ends 2031 (exclusivity)Marketed Haisco-USA Pharmaceuticals 0
Dupilumab Ends 2031 (orphan exclusivity)Marketed Regeneron IL4R 1
Durvalumab Ends 2031 (orphan exclusivity)Marketed AstraZeneca CD274 1
Niraparib Ends 2031 (patent)Marketed GSK PARP1, PARP2 6
Nivolumab Ends 2031 (orphan exclusivity)Marketed Bristol Myers Squibb PDCD1 2
Pembrolizumab Ends 2031 (orphan exclusivity)Marketed Merck & Co. PDCD1 1
Pomalidomide Ends 2031 (patent)Marketed Bristol Myers Squibb CRBN 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 2031 in ear, nose and throat

In the product

5 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.