US protection

US protection ending in 2033: Nutrition and metabolism

As of the edition of 20 October 2026, 20 drugs have US protection that ends in 2033 in nutrition and metabolism; 14 of them have at least one company on route B because of it.

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

20 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Alpelisib Ends 2033 (patent)Marketed Novartis PIK3CA 1
Avalglucosidase alfa Ends 2033 (computed from the first US licence)Marketed Sanofi 0
Cilastatin Ends 2033 (patent)Marketed Merck & Co. DPEP1 1
Copper histidine Ends 2033 (exclusivity)Marketed Sentynl Therapeutics 0
Evinacumab Ends 2033 (computed from the first US licence)Marketed Regeneron ANGPTL3 2
Ibrutinib Ends 2033 (patent)Marketed AbbVie BTK 2
Idecabtagene vicleucel Ends 2033 (computed from the first US licence)Marketed Bristol Myers Squibb TNFRSF17 1
Idelalisib Ends 2033 (patent)Marketed Gilead Sciences PIK3CD 1
Linerixibat Ends 2033 (exclusivity)Marketed Alfasigma SLC10A2 1
Obeticholic acid Ends 2033 (patent)Marketed Alfasigma NR1H4 1
Omaveloxolone Ends 2033 (patent)Marketed Biogen NFE2L2 1
Omega-3-carboxylic acids Ends 2033 (patent)Marketed AstraZeneca 0
Osilodrostat Ends 2033 (patent)Marketed Recordati Rare Diseases CYP11B1 0
Pegcetacoplan Ends 2033 (patent)Marketed Biogen C3 2
Pitolisant Ends 2033 (exclusivity)Marketed Harmony Biosciences HRH3 0
Ponatinib Ends 2033 (patent)Marketed Takeda ABL1 1
Relacorilant Ends 2033 (patent)Marketed Corcept Therapeutics NR3C1 1
Resmetirom Ends 2033 (patent)Marketed Madrigal Pharmaceuticals THRB 1
Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae crm197 Ends 2033 (reference-product exclusivity)Marketed Merck & Co. 0
Tenapanor Ends 2033 (patent)Marketed Ardelyx SLC9A3 2

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 2033 in nutrition and metabolism

In the product

14 of these 20 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.