US protection ending in 2036: Digestive system
As of the edition of 20 October 2026, 19 drugs have US protection that ends in 2036 in digestive system; 14 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
19 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Acalabrutinib | Ends 2036 (patent) | Marketed | AstraZeneca | BTK | 1 |
| Axatilimab | Ends 2036 (computed from the first US licence) | Marketed | Incyte | CSF1R | 1 |
| Cobimetinib | Ends 2036 (patent) | Marketed | Roche | MAP2K1 | 1 |
| Etrasimod | Ends 2036 (patent) | Marketed | Pfizer | S1PR1 | 1 |
| Futibatinib | Ends 2036 (patent) | Marketed | Taiho | FGFR1, FGFR2, FGFR3 | 4 |
| Larotrectinib | Ends 2036 (patent) | Marketed | Bayer | NTRK1, NTRK2, NTRK3 | 3 |
| Lifileucel | Ends 2036 (reference-product exclusivity) | Marketed | Iovance Biotherapeutics | 0 | |
| Nogapendekin alfa inbakicept | Ends 2036 (computed from the first US licence) | Marketed | Altor BioScience | IL15RA, IL2RB, IL2RG | 0 |
| Pexidartinib | Ends 2036 (patent) | Marketed | Daiichi Sankyo | CSF1R, FLT3, KIT | 0 |
| Pirtobrutinib | Ends 2036 (patent) | Marketed | Eli Lilly | BTK | 1 |
| Remestemcel-l | Ends 2036 (computed from the first US licence) | Marketed | Mesoblast | 0 | |
| Repotrectinib | Ends 2036 (patent) | Marketed | Bristol Myers Squibb | NTRK2, NTRK3, ROS1 | 3 |
| Sonidegib | Ends 2036 (patent) | Marketed | SUN Pharmaceutical Industries | SMO | 0 |
| Tislelizumab | Ends 2036 (computed from the first US licence) | Marketed | BeiGene | PDCD1 | 2 |
| Upadacitinib | Ends 2036 (patent) | Marketed | AbbVie | JAK1, JAK2, JAK3 | 3 |
| Vipivotide tetraxetan lutetium | Ends 2036 (patent) | Marketed | Novartis | FOLH1 | 1 |
| Zanidatamab | Ends 2036 (computed from the first US licence) | Marketed | Jazz Pharmaceuticals | ERBB2 | 1 |
| Zenocutuzumab | Ends 2036 (computed from the first US licence) | Marketed | Merus | ERBB2, ERBB3 | 2 |
| Zolbetuximab | Ends 2036 (computed from the first US licence) | Marketed | Astellas | CLDN18 | 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 2036 in digestive system
In the product14 of these 19 drugs have at least one company on route B. Which companies, and their scores, are in the product.
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