US protection

US protection ending in 2033: Immune system

As of the edition of 20 October 2026, 25 drugs have US protection that ends in 2033 in immune system; 18 of them have at least one company on route B because of it.

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

25 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Alpelisib Ends 2033 (patent)Marketed Novartis PIK3CA 1
Anifrolumab Ends 2033 (computed from the first US licence)Marketed AstraZeneca IFNAR1 1
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
Cravacitinib Ends 2033 (patent)Marketed Bristol Myers Squibb TYK2 1
Diroximel fumarate Ends 2033 (patent)Marketed Biogen KEAP1 0
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
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
Pitolisant Ends 2033 (exclusivity)Marketed Harmony Biosciences HRH3 0
Ponatinib Ends 2033 (patent)Marketed Takeda ABL1 1
Resmetirom Ends 2033 (patent)Marketed Madrigal Pharmaceuticals THRB 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
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 immune system

In the product

18 of these 25 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.