US protection

US protection ending in 2033: Infections

As of the edition of 20 October 2026, 20 drugs have US protection that ends in 2033 in infections; 12 of them have at least one company on route B because of it.

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

20 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Anifrolumab Ends 2033 (computed from the first US licence)Marketed AstraZeneca IFNAR1 1
Avibactam Ends 2033 (exclusivity)Marketed AbbVie 0
Axicabtagene ciloleucel Ends 2033 (orphan exclusivity)Marketed Gilead Sciences CD19 0
Cilastatin Ends 2033 (patent)Marketed Merck & Co. DPEP1 1
Cravacitinib Ends 2033 (patent)Marketed Bristol Myers Squibb TYK2 1
Durlobactam Ends 2033 (exclusivity)Marketed Entasis Therapeutics 0
Efgartigimod alfa Ends 2033 (computed from the first US licence)Marketed argenx FCGRT 1
Ibrutinib Ends 2033 (patent)Marketed AbbVie BTK 2
Idecabtagene vicleucel Ends 2033 (computed from the first US licence)Marketed Bristol Myers Squibb TNFRSF17 1
Lefamulin Ends 2033 (patent)Marketed Hong Kong King Friend Industrial 0
Loncastuximab tesirine Ends 2033 (computed from the first US licence)Marketed ADC Therapeutics CD19 2
Luliconazole Ends 2033 (patent)Marketed Bausch Health 0
Obeticholic acid Ends 2033 (patent)Marketed Alfasigma NR1H4 1
Omaveloxolone Ends 2033 (patent)Marketed Biogen NFE2L2 1
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

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 infections

In the product

12 of these 20 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.