US protection ending in 2036: Inherited and neonatal
As of the edition of 20 October 2026, 19 drugs have US protection that ends in 2036 in inherited and neonatal; 16 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 |
|---|---|---|---|---|---|
| Abrocitinib | Ends 2036 (patent) | Marketed | Pfizer | JAK1 | 0 |
| Cobimetinib | Ends 2036 (patent) | Marketed | Roche | MAP2K1 | 1 |
| Concizumab | Ends 2036 (computed from the first US licence) | Marketed | Novo Nordisk | TFPI | 1 |
| Crovalimab | Ends 2036 (computed from the first US licence) | Marketed | Roche | C5 | 1 |
| Difamilast | Ends 2036 (patent) | Marketed | Acrotech Biopharma | PDE4A, PDE4B, PDE4C | 4 |
| Donanemab | Ends 2036 (computed from the first US licence) | Marketed | Eli Lilly | APP | 1 |
| Etrasimod | Ends 2036 (patent) | Marketed | Pfizer | S1PR1 | 1 |
| Fenfluramine | Ends 2036 (patent) | Marketed | UCB | HTR1D, HTR2C, SIGMAR1 | 3 |
| Fidanacogene elaparvovec | Ends 2036 (reference-product exclusivity) | Marketed | Pfizer | 0 | |
| Futibatinib | Ends 2036 (patent) | Marketed | Taiho | FGFR1, FGFR2, FGFR3 | 4 |
| Larotrectinib | Ends 2036 (patent) | Marketed | Bayer | NTRK1, NTRK2, NTRK3 | 3 |
| Lebrikizumab | Ends 2036 (computed from the first US licence) | Marketed | Eli Lilly | IL13 | 1 |
| Marstacimab | Ends 2036 (computed from the first US licence) | Marketed | Pfizer | TFPI | 1 |
| Nemolizumab | Ends 2036 (computed from the first US licence) | Marketed | Galderma | IL31RA | 2 |
| Sonidegib | Ends 2036 (patent) | Marketed | SUN Pharmaceutical Industries | SMO | 0 |
| Sotatercept | Ends 2036 (computed from the first US licence) | Marketed | Merck & Co. | INHBA | 1 |
| Tislelizumab | Ends 2036 (computed from the first US licence) | Marketed | BeiGene | PDCD1 | 2 |
| Upadacitinib | Ends 2036 (patent) | Marketed | AbbVie | JAK1, JAK2, JAK3 | 3 |
| Valbenazine | Ends 2036 (patent) | Marketed | Neurocrine | SLC18A2 | 2 |
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 inherited and neonatal
In the product16 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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