US protection

US protection ending in 2035: Hormones

As of the edition of 20 October 2026, 17 drugs have US protection that ends in 2035 in hormones, 16 of them marketed; 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
Brigatinib Ends 2035 (patent)Marketed Takeda ALK, EGFR 1
Donislecel Ends 2035 (computed from the first US licence)Marketed CellTrans 0
Efbemalenograstim alfa Ends 2035 (computed from the first US licence)Marketed Evive Biotechnology CSF3R 2
Finerenone Ends 2035 (patent)Marketed Bayer NR3C2 0
Florquinitau Ends 2035 (patent)Marketed CERVEAU TECHNOLOGIES INC A LANTHEUS CO MAPT 0
Fruquintinib Ends 2035 (patent)Marketed Takeda FLT1, FLT4, KDR 2
Lenvatinib Ends 2035 (patent)Marketed Eisai FLT1, FLT4, KDR 3
Pafolacianine Ends 2035 (patent)Marketed On Target FOLR1 1
Perflutren Ends 2035 (patent)Marketed Lantheus Medical Imaging 0
Remdesivir Ends 2035 (patent)Marketed Gilead Sciences 0
Retifanlimab Ends 2035 (computed from the first US licence)Marketed Incyte PDCD1 1
Selinexor Ends 2035 (patent)Marketed Karyopharm Therapeutics XPO1 2
Sodium zirconium cyclosilicate Ends 2035 (patent)Marketed AstraZeneca 0
Somatrogon Ends 2035 (computed from the first US licence)Marketed Pfizer GHR 0
Toripalimab Ends 2035 (computed from the first US licence)Marketed Coherus Oncology PDCD1 2
Umbralisib Ends 2035 (patent)Withdrawn from market TG Therapeutics ABL1, PIK3CD 0
Vosoritide Ends 2035 (patent)Marketed Amicus Therapeutics NPR2 1

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 2035 in hormones

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.