US protection

US protection ending in 2036: Infections

As of the edition of 20 October 2026, 12 drugs have US protection that ends in 2036 in infections; 6 of them have at least one company on route B because of it.

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

12 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Abrocitinib Ends 2036 (patent)Marketed Pfizer JAK1 0
Acalabrutinib Ends 2036 (patent)Marketed AstraZeneca BTK 1
Cosibelimab Ends 2036 (computed from the first US licence)Marketed SUN Pharmaceutical Industries CD274 1
Lifileucel Ends 2036 (reference-product exclusivity)Marketed Iovance Biotherapeutics 0
Mavacamten Ends 2036 (patent)Marketed Bristol Myers Squibb MYH7 0
Nogapendekin alfa inbakicept Ends 2036 (computed from the first US licence)Marketed Altor BioScience IL15RA, IL2RB, IL2RG 0
Obecabtagene autoleucel Ends 2036 (reference-product exclusivity)Marketed Autolus CD19 1
Oteseconazole Ends 2036 (patent)Marketed Mycovia Pharmaceuticals 0
Pirtobrutinib Ends 2036 (patent)Marketed Eli Lilly BTK 1
Remestemcel-l Ends 2036 (computed from the first US licence)Marketed Mesoblast 0
Tarlatamab Ends 2036 (computed from the first US licence)Marketed Amgen CD3D, CD3E, CD3G 1
Upadacitinib Ends 2036 (patent)Marketed AbbVie JAK1, JAK2, JAK3 3

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 2036 in infections

In the product

6 of these 12 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.