US protection ending in 2026
As of the edition of 20 October 2026, 43 drugs have US protection that ends (or has ended) in 2026; 20 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
43 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Afamelanotide | Ended 2026 (exclusivity) | Marketed | Clinuvel | MC1R | 1 |
| Albiglutide | Ended 2026 (computed from the first US licence) | Marketed | GSK | GLP1R | 1 |
| Asenapine | Ended 2026 (patent) | Marketed | AbbVie | HTR2A | 3 |
| Belinostat | Ended 2026 (patent) | Marketed | Acrotech Biopharma | 0 | |
| Betrixaban | Ends 2026 (patent) | Marketed | Portola Pharmaceuticals | F10 | 1 |
| Brilliant blue g free acid | Ends 2026 (exclusivity) | Marketed | Dutch Ophthalmic Research Center | 0 | |
| Brivaracetam | Ended 2026 (patent) | Marketed | UCB | SV2A | 1 |
| Conestat alfa | Ended 2026 (reference-product exclusivity) | Marketed | Pharming Americas BV | 0 | |
| Darunavir | Ends 2026 (patent) | Marketed | Johnson & Johnson | 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 | |
| Elvitegravir | Ends 2026 (patent) | Marketed | Gilead Sciences | 0 | |
| Eribulin | Ended 2026 (exclusivity) | Marketed | Eisai | TUBB, TUBB1, TUBB2A | 9 |
| Escitalopram | Ended 2026 (exclusivity) | Marketed | AbbVie | SLC6A4 | 4 |
| Eslicarbazepine acetate | Ended 2026 (patent) | Marketed | Sumitomo Pharma | SCN10A, SCN11A, SCN1A | 2 |
| Gabapentin enacarbil | Ends 2026 (patent) | Marketed | Azurity Pharmaceuticals | CACNA2D1 | 2 |
| Golodirsen | Ends 2026 (exclusivity) | Marketed | Avi Biopharma | DMD | 0 |
| Ivabradine | Ends 2026 (patent) | Marketed | Amgen | HCN4 | 3 |
| Lacosamide | Ended 2026 (exclusivity) | Marketed | UCB | SCN10A, SCN11A, SCN1A | 0 |
| Leuprolide | Ended 2026 (exclusivity) | Marketed | GNRHR | 1 | |
| Linagliptin | Ends 2026 (exclusivity) | Marketed | Boehringer Ingelheim | DPP4 | 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 | |
| Norgestrel | Ended 2026 (exclusivity) | Marketed | Laboratoire Hra Pharma | PGR | 0 |
| Onabotulinumtoxina | Ended 2026 (orphan exclusivity) | Marketed | AbbVie | SNAP25 | 0 |
| Pasireotide | Ends 2026 (patent) | Marketed | Recordati Rare Diseases | SSTR2, SSTR3, SSTR5 | 0 |
| Peginterferon beta-1a | Ended 2026 (computed from the first US licence) | Marketed | Biogen | IFNAR1, IFNAR2 | 0 |
| Perampanel | Ended 2026 (patent) | Marketed | Angelini Pharma | GRIA1, GRIA2, GRIA3 | 4 |
| Ramucirumab | Ended 2026 (orphan exclusivity) | Marketed | Eli Lilly | KDR | 1 |
| Siltuximab | Ended 2026 (computed from the first US licence) | Marketed | Recordati Rare Diseases | IL6 | 2 |
| Sitagliptin | Ends 2026 (patent) | Marketed | Merck & Co. | DPP4 | 1 |
| Susoctocog alfa | Ends 2026 (computed from the first US licence) | Marketed | Takeda | 0 | |
| Technetium tc-99m labeled carbon | Ended 2026 (exclusivity) | Marketed | Cyclomedica | 0 | |
| Teduglutide | Ended 2026 (exclusivity) | Marketed | Takeda | GLP2R | 1 |
| Tiopronin | Ended 2026 (exclusivity) | Marketed | Mission Pharmacal | 0 | |
| Tolvaptan | Ended 2026 (patent) | Marketed | Otsuka | AVPR2 | 0 |
| Triclabendazole | Ended 2026 (exclusivity) | Marketed | Novartis | 0 | |
| Vedolizumab | Ended 2026 (computed from the first US licence) | Marketed | Takeda | ITGA4 | 1 |
| Viloxazine | Ended 2026 (exclusivity) | Marketed | Supernus Pharmaceuticals | SLC6A2 | 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 2026
In the product20 of these 43 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.