US protection

US protection ending in 2033: Blood and lymph

As of the edition of 20 October 2026, 24 drugs have US protection that ends in 2033 in blood and lymph; 16 of them have at least one company on route B because of it.

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

24 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Alpelisib Ends 2033 (patent)Marketed Novartis PIK3CA 1
Apalutamide Ends 2033 (patent)Marketed Johnson & Johnson AR 0
Avibactam Ends 2033 (exclusivity)Marketed AbbVie 0
Axicabtagene ciloleucel Ends 2033 (orphan exclusivity)Marketed Gilead Sciences CD19 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
Cravacitinib Ends 2033 (patent)Marketed Bristol Myers Squibb TYK2 1
Dostarlimab Ends 2033 (computed from the first US licence)Marketed GSK PDCD1 1
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
Fitusiran Ends 2033 (patent)Marketed Sanofi SERPINC1 0
Ibrutinib Ends 2033 (patent)Marketed AbbVie BTK 2
Idecabtagene vicleucel Ends 2033 (computed from the first US licence)Marketed Bristol Myers Squibb TNFRSF17 1
Idelalisib Ends 2033 (patent)Marketed Gilead Sciences PIK3CD 1
Ivosidenib Ends 2033 (patent)Marketed Servier IDH1 0
Lisocabtagene maraleucel Ends 2033 (computed from the first US licence)Marketed Juno Therapeutics CD19 2
Loncastuximab tesirine Ends 2033 (computed from the first US licence)Marketed ADC Therapeutics CD19 2
Pegcetacoplan Ends 2033 (patent)Marketed Biogen C3 2
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
Tezepelumab Ends 2033 (computed from the first US licence)Marketed AstraZeneca TSLP 1
Tozinameran Ends 2033 (computed from the first US licence)Marketed BioNTech Manufacturing GmbH 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 2033 in blood and lymph

In the product

16 of these 24 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.