US protection

US protection ending in 2033: Lungs and airways

As of the edition of 20 October 2026, 27 drugs have US protection that ends in 2033 in lungs and airways; 18 of them have at least one company on route B because of it.

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

27 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Alpelisib Ends 2033 (patent)Marketed Novartis PIK3CA 1
Amivantamab Ends 2033 (computed from the first US licence)Marketed Johnson & Johnson EGFR, MET 1
Anifrolumab Ends 2033 (computed from the first US licence)Marketed AstraZeneca IFNAR1 1
Apalutamide Ends 2033 (patent)Marketed Johnson & Johnson AR 0
Avibactam Ends 2033 (exclusivity)Marketed AbbVie 0
Binimetinib Ends 2033 (patent)Marketed Pfizer MAP2K1, MAP2K2 6
Capivasertib Ends 2033 (patent)Marketed AstraZeneca AKT1, AKT2, AKT3 3
Cilastatin Ends 2033 (patent)Marketed Merck & Co. DPEP1 1
Dostarlimab Ends 2033 (computed from the first US licence)Marketed GSK PDCD1 1
Durlobactam Ends 2033 (exclusivity)Marketed Entasis Therapeutics 0
Efgartigimod alfa Ends 2033 (computed from the first US licence)Marketed argenx FCGRT 1
Erdafitinib Ends 2033 (patent)Marketed Johnson & Johnson FGFR1, FGFR2, FGFR3 4
Ibrutinib Ends 2033 (patent)Marketed AbbVie BTK 2
Idelalisib Ends 2033 (patent)Marketed Gilead Sciences PIK3CD 1
Ivosidenib Ends 2033 (patent)Marketed Servier IDH1 0
Lefamulin Ends 2033 (patent)Marketed Hong Kong King Friend Industrial 0
Omaveloxolone Ends 2033 (patent)Marketed Biogen NFE2L2 1
Pitolisant Ends 2033 (exclusivity)Marketed Harmony Biosciences HRH3 0
Ponatinib Ends 2033 (patent)Marketed Takeda ABL1 1
Ropeginterferon alfa-2b Ends 2033 (computed from the first US licence)Marketed PharmaEssentia IFNAR1, IFNAR2 0
Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae crm197 Ends 2033 (reference-product exclusivity)Marketed Merck & Co. 0
Taletrectinib Ends 2033 (patent)Marketed Nuvation Bio NTRK1, NTRK2, NTRK3 8
Tenapanor Ends 2033 (patent)Marketed Ardelyx SLC9A3 2
Tezepelumab Ends 2033 (computed from the first US licence)Marketed AstraZeneca TSLP 1
Tisotumab vedotin Ends 2033 (computed from the first US licence)Marketed Pfizer F3, TUBB, TUBB1 11
Tozinameran Ends 2033 (computed from the first US licence)Marketed BioNTech Manufacturing GmbH 0
Tralokinumab Ends 2033 (computed from the first US licence)Marketed LEO Pharma IL13 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 2033 in lungs and airways

In the product

18 of these 27 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.