US protection

US protection ending in 2031: Chemically induced

As of the edition of 20 October 2026, 14 drugs have US protection that ends in 2031 in chemically induced; 9 of them have at least one company on route B because of it.

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

14 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Benralizumab Ends 2031 (orphan exclusivity)Marketed AstraZeneca IL5RA 0
Blinatumomab Ends 2031 (orphan exclusivity)Marketed Amgen CD19, CD3D, CD3E 0
Cabotegravir Ends 2031 (patent)Marketed GSK 0
Dolutegravir Ends 2031 (patent)Marketed GSK 0
Dupilumab Ends 2031 (orphan exclusivity)Marketed Regeneron IL4R 1
Durvalumab Ends 2031 (orphan exclusivity)Marketed AstraZeneca CD274 1
Elbasvir Ends 2031 (patent)Marketed Merck & Co. 0
Lemborexant Ends 2031 (patent)Marketed Eisai HCRTR1, HCRTR2 2
Lutetium oxodotreotide Ends 2031 (exclusivity)Marketed Advanced Accelerator Applications SSTR1, SSTR2, SSTR3 10
Nivolumab Ends 2031 (orphan exclusivity)Marketed Bristol Myers Squibb PDCD1 2
Pembrolizumab Ends 2031 (orphan exclusivity)Marketed Merck & Co. PDCD1 1
Polatuzumab vedotin Ends 2031 (computed from the first US licence)Marketed Roche CD79B, TUBB, TUBB1 1
Telotristat ethyl Ends 2031 (patent)Marketed TerSera Therapeutics TPH1, TPH2 4
Trastuzumab deruxtecan Ends 2031 (computed from the first US licence)Marketed Daiichi Sankyo ERBB2, TOP1 3

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 chemically induced

In the product

9 of these 14 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.