US protection

US protection ending in 2030: Inherited and neonatal

As of the edition of 20 October 2026, 31 drugs have US protection that ends in 2030 in inherited and neonatal; 21 of them have at least one company on route B because of it.

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

31 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
Birch triterpenes Ends 2030 (exclusivity)Marketed Chiesi Farmaceutici 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
Casimersen Ends 2030 (patent)Marketed Avi Biopharma DMD 0
Cemiplimab Ends 2030 (computed from the first US licence)Marketed Regeneron PDCD1 2
Cenegermin Ends 2030 (computed from the first US licence)Marketed Dompé Farmaceutici NTRK1, NTRK2, NTRK3 3
Coagulation factor x human Ends 2030 (orphan exclusivity)Marketed Bio Products Laboratory Limited 0
Dabrafenib Ends 2030 (patent)Marketed Novartis BRAF 1
Damoctocog alfa pegol Ends 2030 (computed from the first US licence)Marketed Bayer 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
Elinzanetant Ends 2030 (exclusivity)Marketed Bayer TACR1, TACR3 2
Encorafenib Ends 2030 (exclusivity)Marketed Pfizer BRAF 3
Lanadelumab Ends 2030 (computed from the first US licence)Marketed Takeda KLKB1 1
Neratinib Ends 2030 (patent)Marketed Puma Biotechnology EGFR 2
Nusinersen Ends 2030 (patent)Marketed Biogen SMN2 1
Omadacycline Ends 2030 (patent)Marketed Transcept Pharmaceuticals 0
Pacritinib Ends 2030 (patent)Marketed Swedish Orphan Biovitrum FLT3, JAK2 2
Palovarotene Ends 2030 (exclusivity)Marketed Ipsen RARG 1
Pegvaliase Ends 2030 (computed from the first US licence)Marketed Amicus Therapeutics 0
Pimavanserin Ends 2030 (patent)Marketed Acadia Pharmaceuticals HTR2A 1
Sildenafil Ends 2030 (exclusivity)Marketed Viatris PDE5A 3
Tagraxofusp Ends 2030 (computed from the first US licence)Marketed Stemline Therapeutics EEF2, IL3RA 4
Tildrakizumab Ends 2030 (computed from the first US licence)Marketed SUN Pharmaceutical Industries IL23A 1
Tradipitant Ends 2030 (exclusivity)Marketed Vanda Pharmaceuticals TACR1 1
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 inherited and neonatal

In the product

21 of these 31 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.