US protection ending in 2028
As of the edition of 20 October 2026, 55 drugs have US protection that ends in 2028; 32 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
55 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Abatacept | Ends 2028 (orphan exclusivity) | Marketed | Bristol Myers Squibb | CD80, CD86 | 0 |
| Adalimumab | Ends 2028 (orphan exclusivity) | Marketed | AbbVie | TNF | 4 |
| Agalsidase beta | Ends 2028 (orphan exclusivity) | Marketed | Sanofi | 0 | |
| Albutrepenonacog alfa | Ends 2028 (computed from the first US licence) | Marketed | CSL Behring Lengnau AG | 0 | |
| Alirocumab | Ends 2028 (orphan exclusivity) | Marketed | Regeneron | PCSK9 | 2 |
| Alogliptin | Ends 2028 (patent) | Marketed | Takeda | DPP4 | 0 |
| Apixaban | Ends 2028 (exclusivity) | Marketed | Bristol Myers Squibb | F10 | 2 |
| Apremilast | Ends 2028 (patent) | Marketed | Amgen | PDE4A, PDE4B, PDE4C | 4 |
| Bezlotoxumab | Ends 2028 (computed from the first US licence) | Marketed | Merck & Co. | 0 | |
| Brexpiprazole | Ends 2028 (patent) | Marketed | Otsuka | DRD2, HTR1A, HTR2A | 2 |
| Buprenorphine | Ends 2028 (exclusivity) | Marketed | Indivior | OPRK1, OPRM1 | 9 |
| Cantharidin | Ends 2028 (exclusivity) | Marketed | Verrica Pharmaceuticals | 0 | |
| Carfilzomib | Ends 2028 (exclusivity) | Marketed | Amgen | PSMB5 | 2 |
| Carglumic acid | Ends 2028 (exclusivity) | Marketed | Recordati Rare Diseases | CPS1 | 0 |
| Daratumumab | Ends 2028 (orphan exclusivity) | Marketed | Johnson & Johnson | CD38 | 1 |
| Deferiprone | Ends 2028 (exclusivity) | Marketed | Chiesi | 0 | |
| Deoxycholic acid | Ends 2028 (patent) | Marketed | AbbVie | 0 | |
| Doxercalciferol | Ends 2028 (exclusivity) | Marketed | Sanofi | VDR | 1 |
| Empagliflozin | Ends 2028 (patent) | Marketed | Boehringer Ingelheim | SLC5A2 | 1 |
| Esketamine | Ends 2028 (exclusivity) | Marketed | Johnson & Johnson | GRIN1, GRIN2A, GRIN2B | 5 |
| Evolocumab | Ends 2028 (orphan exclusivity) | Marketed | Amgen | PCSK9 | 2 |
| Ferric oxyhydroxide | Ends 2028 (exclusivity) | Marketed | Vifor Fresenius Medical Care Renal Pharma | 0 | |
| Ferumoxytol | Ends 2028 (exclusivity) | Marketed | Azurity Pharmaceuticals | 0 | |
| Fexinidazole | Ends 2028 (exclusivity) | Marketed | Sanofi | 0 | |
| Flibanserin | Ends 2028 (exclusivity) | Marketed | Sprout Pharmaceuticals | HTR1A, HTR2A | 2 |
| Fosdenopterin | Ends 2028 (exclusivity) | Marketed | Sentynl Therapeutics | MOCS1 | 2 |
| Gepirone | Ends 2028 (exclusivity) | Marketed | Fabre Kramer Pharmaceuticals | HTR1A | 1 |
| Iopamidol | Ends 2028 (exclusivity) | Marketed | Bracco Diagnostics | 0 | |
| Ixekizumab | Ends 2028 (computed from the first US licence) | Marketed | Eli Lilly | IL17A | 1 |
| Levoketoconazole | Ends 2028 (exclusivity) | Marketed | Cortendo | CYP11A1, CYP11B1, CYP11B2 | 4 |
| Lixisenatide | Ends 2028 (computed from the first US licence) | Marketed | Sanofi | GLP1R | 1 |
| Lonoctocog alfa | Ends 2028 (computed from the first US licence) | Marketed | CSL Behring Lengnau AG | 0 | |
| Obiltoxaximab | Ends 2028 (computed from the first US licence) | Marketed | Elusys Therapeutics | 0 | |
| Olaparib | Ends 2028 (patent) | Marketed | AstraZeneca | PARP1, PARP2, PARP3 | 3 |
| Olaratumab | Ends 2028 (computed from the first US licence) | Marketed | Eli Lilly | PDGFRA | 0 |
| Oxybate | Ends 2028 (exclusivity) | Marketed | GABBR1, GABBR2 | 2 | |
| Panobinostat | Ends 2028 (patent) | Marketed | Secura Bio | 0 | |
| Perfluorohexyloctane | Ends 2028 (exclusivity) | Marketed | Bausch Health | 0 | |
| Prucalopride | Ends 2028 (exclusivity) | Marketed | Takeda | HTR4 | 1 |
| Reslizumab | Ends 2028 (computed from the first US licence) | Marketed | Teva | IL5 | 1 |
| Rifamycin | Ends 2028 (exclusivity) | Marketed | Cosmo Technologies | 0 | |
| Rilonacept | Ends 2028 (orphan exclusivity) | Marketed | Kiniksa Pharmaceuticals | IL1B | 1 |
| Rituximab | Ends 2028 (orphan exclusivity) | Marketed | Roche | MS4A1 | 1 |
| Rolapitant | Ends 2028 (patent) | Marketed | TerSera Therapeutics | TACR1 | 2 |
| Romiplostim | Ends 2028 (orphan exclusivity) | Marketed | Amgen | MPL | 2 |
| Safinamide | Ends 2028 (patent) | Marketed | Supernus Pharmaceuticals | MAOB | 1 |
| Siponimod | Ends 2028 (patent) | Marketed | Novartis | S1PR1 | 0 |
| Sugammadex | Ends 2028 (exclusivity) | Marketed | Merck & Co. | 0 | |
| Tacrolimus anhydrous | Ends 2028 (exclusivity) | Marketed | Astellas | FKBP1A | 3 |
| Tivozanib | Ends 2028 (patent) | Marketed | LG Chem | FLT1, FLT4, KDR | 5 |
| Tocilizumab | Ends 2028 (orphan exclusivity) | Marketed | Roche | IL6R | 0 |
| Tofacitinib | Ends 2028 (exclusivity) | Marketed | Pfizer | JAK1, JAK2, JAK3 | 2 |
| Treprostinil | Ends 2028 (patent) | Marketed | United Therapeutics | PTGIR | 3 |
| Vibrio cholerae, live attenuated | Ends 2028 (computed from the first US licence) | Marketed | Bavarian Nordic | 0 | |
| Vismodegib | Ends 2028 (patent) | Marketed | Roche | SMO | 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 2028
In the product32 of these 55 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.