US protection ending in 2033: Inherited and neonatal
As of the edition of 20 October 2026, 26 drugs have US protection that ends in 2033 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.
26 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Alpelisib | Ends 2033 (patent) | Marketed | Novartis | PIK3CA | 1 |
| Amivantamab | Ends 2033 (computed from the first US licence) | Marketed | Johnson & Johnson | EGFR, MET | 1 |
| Apalutamide | Ends 2033 (patent) | Marketed | Johnson & Johnson | AR | 0 |
| Avalglucosidase alfa | Ends 2033 (computed from the first US licence) | Marketed | Sanofi | 0 | |
| Avibactam | Ends 2033 (exclusivity) | Marketed | AbbVie | 0 | |
| Binimetinib | Ends 2033 (patent) | Marketed | Pfizer | MAP2K1, MAP2K2 | 6 |
| Capivasertib | Ends 2033 (patent) | Marketed | AstraZeneca | AKT1, AKT2, AKT3 | 3 |
| Cilastatin | Ends 2033 (patent) | Marketed | Merck & Co. | DPEP1 | 1 |
| Copper histidine | Ends 2033 (exclusivity) | Marketed | Sentynl Therapeutics | 0 | |
| Cravacitinib | Ends 2033 (patent) | Marketed | Bristol Myers Squibb | TYK2 | 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 |
| Evinacumab | Ends 2033 (computed from the first US licence) | Marketed | Regeneron | ANGPTL3 | 2 |
| Fitusiran | Ends 2033 (patent) | Marketed | Sanofi | SERPINC1 | 0 |
| Ivosidenib | Ends 2033 (patent) | Marketed | Servier | IDH1 | 0 |
| Lefamulin | Ends 2033 (patent) | Marketed | Hong Kong King Friend Industrial | 0 | |
| Lonapegsomatropin | Ends 2033 (computed from the first US licence) | Marketed | Ascendis Pharma A/S | GHR | 1 |
| Obeticholic acid | Ends 2033 (patent) | Marketed | Alfasigma | NR1H4 | 1 |
| Omaveloxolone | Ends 2033 (patent) | Marketed | Biogen | NFE2L2 | 1 |
| Osilodrostat | Ends 2033 (patent) | Marketed | Recordati Rare Diseases | CYP11B1 | 0 |
| Pitolisant | Ends 2033 (exclusivity) | Marketed | Harmony Biosciences | HRH3 | 0 |
| Ponatinib | Ends 2033 (patent) | Marketed | Takeda | ABL1 | 1 |
| Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae crm197 | Ends 2033 (reference-product exclusivity) | Marketed | Merck & Co. | 0 | |
| Tenapanor | Ends 2033 (patent) | Marketed | Ardelyx | SLC9A3 | 2 |
| Tezepelumab | Ends 2033 (computed from the first US licence) | Marketed | AstraZeneca | TSLP | 1 |
| 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 inherited and neonatal
In the product16 of these 26 drugs have at least one company on route B. Which companies, and their scores, are in the product.
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