US protection

US protection ending in 2031: Nutrition and metabolism

As of the edition of 20 October 2026, 24 drugs have US protection that ends in 2031 in nutrition and metabolism; 15 of them have at least one company on route B because of it.

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

24 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Bosutinib Ends 2031 (exclusivity)Marketed Pfizer ABL1 1
Cabotegravir Ends 2031 (patent)Marketed GSK 0
Cerliponase alfa Ends 2031 (orphan exclusivity)Marketed Amicus Therapeutics 0
Cipepofol Ends 2031 (exclusivity)Marketed Haisco-USA Pharmaceuticals 0
Daclatasvir Ends 2031 (patent)Marketed Bristol Myers Squibb 0
Dolutegravir Ends 2031 (patent)Marketed GSK 0
Elafibranor Ends 2031 (exclusivity)Marketed Ipsen PPARA, PPARD 2
Elbasvir Ends 2031 (patent)Marketed Merck & Co. 0
Ertugliflozin Ends 2031 (patent)Marketed Merck & Co. SLC5A2 1
Etelcalcetide Ends 2031 (patent)Marketed Amgen CASR 1
Iberdomide Ends 2031 (exclusivity)Marketed Bristol Myers Squibb CRBN, CUL4A, DDB1 0
Inotersen Ends 2031 (patent)Marketed Akcea Therapeutics TTR 1
Lemborexant Ends 2031 (patent)Marketed Eisai HCRTR1, HCRTR2 2
Letrozole Ends 2031 (patent)Marketed Novartis CYP19A1 1
Levacetylleucine Ends 2031 (exclusivity)Marketed IntraBio F9 1
Mavorixafor Ends 2031 (exclusivity)Marketed X4 Pharmaceuticals CXCR4 2
Nitrous acid Ends 2031 (patent)Marketed Hope Biosciences 0
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
Romosozumab Ends 2031 (computed from the first US licence)Marketed Amgen SOST 2
Rucaparib Ends 2031 (patent)Marketed pharmaand PARP1, PARP2, PARP3 5
Seladelpar Ends 2031 (exclusivity)Marketed Gilead Sciences PPARD 1
Vortioxetine Ends 2031 (patent)Marketed Takeda HTR1A, HTR3A, SLC6A4 5

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 nutrition and metabolism

In the product

15 of these 24 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.