US protection

US protection ending in 2030: Hormones

As of the edition of 20 October 2026, 19 drugs have US protection that ends in 2030 in hormones; 15 of them have at least one company on route B because of it.

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

19 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Aflibercept Ends 2030 (orphan exclusivity)Marketed Regeneron PGF, VEGFA 4
Atrasentan Ends 2030 (exclusivity)Marketed Novartis EDNRA 1
Axitinib Ends 2030 (patent)Marketed Pfizer FLT1, FLT4, KDR 0
Burosumab Ends 2030 (computed from the first US licence)Marketed Kyowa Kirin FGF23 1
Calaspargase pegol Ends 2030 (computed from the first US licence)Marketed Servier 0
Cemiplimab Ends 2030 (computed from the first US licence)Marketed Regeneron PDCD1 2
Dabrafenib Ends 2030 (patent)Marketed Novartis BRAF 1
Elinzanetant Ends 2030 (exclusivity)Marketed Bayer TACR1, TACR3 2
Emapalumab Ends 2030 (computed from the first US licence)Marketed Swedish Orphan Biovitrum IFNG 1
Encorafenib Ends 2030 (exclusivity)Marketed Pfizer BRAF 3
Lifitegrast Ends 2030 (patent)Marketed Bausch Health ITGAL 1
Macimorelin Ends 2030 (exclusivity)Marketed COSCIENS Biopharma GHSR 2
Neratinib Ends 2030 (patent)Marketed Puma Biotechnology EGFR 2
Omadacycline Ends 2030 (patent)Marketed Transcept Pharmaceuticals 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
Trametinib Ends 2030 (patent)Marketed Novartis MAP2K1, MAP2K2 2
Vemurafenib Ends 2030 (patent)Marketed Roche BRAF 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 2030 in hormones

In the product

15 of these 19 drugs have at least one company on route B. Which companies, and their scores, are in the product.

Get this list with the companies, scores and sources as a fileRequest access. Nothing is shown until you do.

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.