US protection ending in 2035: Inherited and neonatal
As of the edition of 20 October 2026, 26 drugs have US protection that ends in 2035 in inherited and neonatal, 25 of them marketed; 13 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 |
|---|---|---|---|---|---|
| Apadamtase alfa | Ends 2035 (computed from the first US licence) | Marketed | Takeda | 0 | |
| Beremagene geperpavec | Ends 2035 (computed from the first US licence) | Marketed | Krystal Biotech | 0 | |
| Bimekizumab | Ends 2035 (computed from the first US licence) | Marketed | UCB | IL17A, IL17F | 2 |
| Brensocatib | Ends 2035 (patent) | Marketed | Insmed | CTSC | 1 |
| Brigatinib | Ends 2035 (patent) | Marketed | Takeda | ALK, EGFR | 1 |
| Cefiderocol | Ends 2035 (patent) | Marketed | Shionogi | 0 | |
| Cipaglucosidase alfa | Ends 2035 (computed from the first US licence) | Marketed | Amicus Therapeutics | IGF2R | 1 |
| Delandistrogene moxeparvovec | Ends 2035 (reference-product exclusivity) | Marketed | Avi Biopharma | 0 | |
| Efanesoctocog alfa | Ends 2035 (computed from the first US licence) | Marketed | Bioverativ Therapeutics | 0 | |
| Elranatamab | Ends 2035 (computed from the first US licence) | Marketed | Pfizer | CD3E, TNFRSF17 | 1 |
| Exagamglogene autotemcel | Ends 2035 (computed from the first US licence) | Marketed | Vertex | BCL11A | 1 |
| Finerenone | Ends 2035 (patent) | Marketed | Bayer | NR3C2 | 0 |
| Florquinitau | Ends 2035 (patent) | Marketed | CERVEAU TECHNOLOGIES INC A LANTHEUS CO | MAPT | 0 |
| Lenvatinib | Ends 2035 (patent) | Marketed | Eisai | FLT1, FLT4, KDR | 3 |
| Omidubicel | Ends 2035 (computed from the first US licence) | Marketed | Gamida Cell | 0 | |
| Pegunigalsidase alfa | Ends 2035 (computed from the first US licence) | Marketed | Chiesi Farmaceutici | 0 | |
| Perflutren | Ends 2035 (patent) | Marketed | Lantheus Medical Imaging | 0 | |
| Retifanlimab | Ends 2035 (computed from the first US licence) | Marketed | Incyte | PDCD1 | 1 |
| Selinexor | Ends 2035 (patent) | Marketed | Karyopharm Therapeutics | XPO1 | 2 |
| Tafamidis | Ends 2035 (patent) | Marketed | Pfizer | TTR | 1 |
| Tasimelteon | Ends 2035 (patent) | Marketed | Vanda Pharmaceuticals | MTNR1A, MTNR1B | 2 |
| Toripalimab | Ends 2035 (computed from the first US licence) | Marketed | Coherus Oncology | PDCD1 | 2 |
| Valoctocogene roxaparvovec | Ends 2035 (computed from the first US licence) | Marketed | Amicus Therapeutics | 0 | |
| Velmanase alfa | Ends 2035 (computed from the first US licence) | Marketed | Chiesi Farmaceutici | 0 | |
| Vosoritide | Ends 2035 (patent) | Marketed | Amicus Therapeutics | NPR2 | 1 |
| Voxelotor | Ends 2035 (patent) | Withdrawn from market | Pfizer | HBA1 | 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 2035 in inherited and neonatal
In the product13 of these 26 drugs have at least one company on route B. Which companies, and their scores, are in the product.
Get this list with the companies, scores and sources as a fileRequest access. Nothing is shown until you do.