US protection ending in 2026: Inherited and neonatal
As of the edition of 20 October 2026, 23 drugs have US protection that ends (or has ended) in 2026 in inherited and neonatal; 8 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
23 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Afamelanotide | Ended 2026 (exclusivity) | Marketed | Clinuvel | MC1R | 1 |
| Asenapine | Ended 2026 (patent) | Marketed | AbbVie | HTR2A | 3 |
| Belinostat | Ended 2026 (patent) | Marketed | Acrotech Biopharma | 0 | |
| Brivaracetam | Ended 2026 (patent) | Marketed | UCB | SV2A | 1 |
| Conestat alfa | Ended 2026 (reference-product exclusivity) | Marketed | Pharming Americas BV | 0 | |
| Dasatinib anhydrous | Ended 2026 (exclusivity) | Marketed | ABL1, BLK, FGR | 12 | |
| Deflazacort | Ended 2026 (exclusivity) | Marketed | PTC Therapeutics | NR3C1 | 0 |
| Dulaglutide | Ended 2026 (computed from the first US licence) | Marketed | Eli Lilly | GLP1R | 0 |
| Efmoroctocog alfa | Ended 2026 (computed from the first US licence) | Marketed | Bioverativ Therapeutics | 0 | |
| Eftrenonacog alfa | Ended 2026 (computed from the first US licence) | Marketed | Bioverativ Therapeutics | 0 | |
| Elosulfase alfa | Ended 2026 (computed from the first US licence) | Marketed | Amicus Therapeutics | 0 | |
| Golodirsen | Ends 2026 (exclusivity) | Marketed | Avi Biopharma | DMD | 0 |
| Ivabradine | Ends 2026 (patent) | Marketed | Amgen | HCN4 | 3 |
| Leuprolide | Ended 2026 (exclusivity) | Marketed | GNRHR | 1 | |
| Metreleptin | Ended 2026 (computed from the first US licence) | Marketed | Chiesi Farmaceutici | LEPR | 0 |
| Neisseria meningitidis factor h binding protein | Ends 2026 (reference-product exclusivity) | Marketed | Pfizer | 0 | |
| Onabotulinumtoxina | Ended 2026 (orphan exclusivity) | Marketed | AbbVie | SNAP25 | 0 |
| Pasireotide | Ends 2026 (patent) | Marketed | Recordati Rare Diseases | SSTR2, SSTR3, SSTR5 | 0 |
| Perampanel | Ended 2026 (patent) | Marketed | Angelini Pharma | GRIA1, GRIA2, GRIA3 | 4 |
| Sitagliptin | Ends 2026 (patent) | Marketed | Merck & Co. | DPP4 | 1 |
| Susoctocog alfa | Ends 2026 (computed from the first US licence) | Marketed | Takeda | 0 | |
| Tiopronin | Ended 2026 (exclusivity) | Marketed | Mission Pharmacal | 0 | |
| Tolvaptan | Ended 2026 (patent) | Marketed | Otsuka | AVPR2 | 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 2026 in inherited and neonatal
In the product8 of these 23 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.