US protection

US protection ending in 2035: Lungs and airways

As of the edition of 20 October 2026, 23 drugs have US protection that ends in 2035 in lungs and airways, 22 of them marketed; 11 of them have at least one company on route B because of it.

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

23 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Bictegravir Ends 2035 (patent)Marketed Gilead Sciences 0
Bimekizumab Ends 2035 (computed from the first US licence)Marketed UCB IL17A, IL17F 2
Brensocatib Ends 2035 (patent)Marketed Insmed CTSC 1
Brigatinib Ends 2035 (patent)Marketed Takeda ALK, EGFR 1
Cefiderocol Ends 2035 (patent)Marketed Shionogi 0
Danicopan Ends 2035 (patent)Marketed AstraZeneca CFD 1
Efbemalenograstim alfa Ends 2035 (computed from the first US licence)Marketed Evive Biotechnology CSF3R 2
Ferric maltol Ends 2035 (patent)Marketed Shield Tx 0
Fruquintinib Ends 2035 (patent)Marketed Takeda FLT1, FLT4, KDR 2
Glecaprevir Ends 2035 (patent)Marketed AbbVie 0
Ibrexafungerp Ends 2035 (patent)Marketed GSK 0
Lenvatinib Ends 2035 (patent)Marketed Eisai FLT1, FLT4, KDR 3
Mobocertinib Ends 2035 (patent)Marketed Takeda EGFR 0
Netupitant Ends 2035 (patent)Marketed Helsinn Healthcare TACR1 0
Nirsevimab Ends 2035 (computed from the first US licence)Marketed Sanofi 0
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
Respiratory syncytial virus pre-fusion glycoprotein f Ends 2035 (reference-product exclusivity)Marketed GSK 0
Retifanlimab Ends 2035 (computed from the first US licence)Marketed Incyte PDCD1 1
Selinexor Ends 2035 (patent)Marketed Karyopharm Therapeutics XPO1 2
Toripalimab Ends 2035 (computed from the first US licence)Marketed Coherus Oncology PDCD1 2
Voxelotor Ends 2035 (patent)Withdrawn from market Pfizer HBA1 0

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 lungs and airways

In the product

11 of these 23 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.