US protection

US protection ending in 2030: Nutrition and metabolism

As of the edition of 20 October 2026, 17 drugs have US protection that ends in 2030 in nutrition and metabolism; 9 of them have at least one company on route B because of it.

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

17 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Aflibercept Ends 2030 (orphan exclusivity)Marketed Regeneron PGF, VEGFA 4
Atrasentan Ends 2030 (exclusivity)Marketed Novartis EDNRA 1
Burosumab Ends 2030 (computed from the first US licence)Marketed Kyowa Kirin FGF23 1
Coagulation factor x human Ends 2030 (orphan exclusivity)Marketed Bio Products Laboratory Limited 0
Doxecitine Ends 2030 (exclusivity)Marketed UCB 0
Elapegademase Ends 2030 (computed from the first US licence)Marketed Chiesi 0
Eliglustat Ends 2030 (patent)Marketed Sanofi UGCG 1
Nusinersen Ends 2030 (patent)Marketed Biogen SMN2 1
Omadacycline Ends 2030 (patent)Marketed Transcept Pharmaceuticals 0
Patiromer sorbitex calcium Ends 2030 (patent)Marketed Sanofi 0
Pegvaliase Ends 2030 (computed from the first US licence)Marketed Amicus Therapeutics 0
Raltegravir Ends 2030 (patent)Marketed Merck & Co. 0
Ravulizumab Ends 2030 (computed from the first US licence)Marketed AstraZeneca C5 0
Sildenafil Ends 2030 (exclusivity)Marketed Viatris PDE5A 3
Sotagliflozin Ends 2030 (patent)Marketed Lexicon Pharmaceuticals SLC5A2 2
Tradipitant Ends 2030 (exclusivity)Marketed Vanda Pharmaceuticals TACR1 1
Trametinib Ends 2030 (patent)Marketed Novartis MAP2K1, MAP2K2 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 2030 in nutrition and metabolism

In the product

9 of these 17 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.