US protection ending in 2031
As of the edition of 20 October 2026, 68 drugs have US protection that ends in 2031; 42 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
68 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Abemaciclib | Ends 2031 (patent) | Marketed | Eli Lilly | CDK4, CDK6 | 2 |
| Alectinib | Ends 2031 (patent) | Marketed | Roche | ALK, RET | 1 |
| Benralizumab | Ends 2031 (orphan exclusivity) | Marketed | AstraZeneca | IL5RA | 0 |
| Besifloxacin | Ends 2031 (patent) | Marketed | Bausch Health | 0 | |
| Bimatoprost | Ends 2031 (patent) | Marketed | AbbVie | PTGFR | 3 |
| Blinatumomab | Ends 2031 (orphan exclusivity) | Marketed | Amgen | CD19, CD3D, CD3E | 0 |
| Bosutinib | Ends 2031 (exclusivity) | Marketed | Pfizer | ABL1 | 1 |
| Brolucizumab | Ends 2031 (computed from the first US licence) | Marketed | Novartis | VEGFA | 0 |
| Cabotegravir | Ends 2031 (patent) | Marketed | GSK | 0 | |
| Caplacizumab | Ends 2031 (computed from the first US licence) | Marketed | Ablynx | VWF | 1 |
| Cerliponase alfa | Ends 2031 (orphan exclusivity) | Marketed | Amicus Therapeutics | 0 | |
| Chimeric yellow fever dengue virus, live attenuated | Ends 2031 (reference-product exclusivity) | Marketed | Sanofi | 0 | |
| Cipepofol | Ends 2031 (exclusivity) | Marketed | Haisco-USA Pharmaceuticals | 0 | |
| Crizanlizumab | Ends 2031 (computed from the first US licence) | Marketed | Novartis | SELP | 1 |
| Daclatasvir | Ends 2031 (patent) | Marketed | Bristol Myers Squibb | 0 | |
| Delafloxacin | Ends 2031 (patent) | Marketed | Melinta Therapeutics | 0 | |
| Delgocitinib | Ends 2031 (patent) | Marketed | LEO Pharma | JAK1, JAK2, JAK3 | 4 |
| Dolutegravir | Ends 2031 (patent) | Marketed | GSK | 0 | |
| Dupilumab | Ends 2031 (orphan exclusivity) | Marketed | Regeneron | IL4R | 1 |
| Durvalumab | Ends 2031 (orphan exclusivity) | Marketed | AstraZeneca | CD274 | 1 |
| Elafibranor | Ends 2031 (exclusivity) | Marketed | Ipsen | PPARA, PPARD | 2 |
| Elbasvir | Ends 2031 (patent) | Marketed | Merck & Co. | 0 | |
| Enfortumab vedotin | Ends 2031 (computed from the first US licence) | Marketed | Astellas | NECTIN4, TUBB, TUBB1 | 1 |
| Ensifentrine | Ends 2031 (patent) | Marketed | Merck & Co. | PDE3A, PDE3B, PDE4A | 4 |
| Ertugliflozin | Ends 2031 (patent) | Marketed | Merck & Co. | SLC5A2 | 1 |
| Etelcalcetide | Ends 2031 (patent) | Marketed | Amgen | CASR | 1 |
| Fedratinib | Ends 2031 (patent) | Marketed | Bristol Myers Squibb | FLT3, JAK2 | 2 |
| Fostamatinib | Ends 2031 (patent) | Marketed | Rigel Pharmaceuticals | SYK | 3 |
| Gedatolisib | Ends 2031 (exclusivity) | Marketed | Celcuity | MTOR, PIK3CA, PIK3CB | 5 |
| Iberdomide | Ends 2031 (exclusivity) | Marketed | Bristol Myers Squibb | CRBN, CUL4A, DDB1 | 0 |
| Imetelstat sodium | Ends 2031 (exclusivity) | Marketed | Geron | TERT | 1 |
| Inotersen | Ends 2031 (patent) | Marketed | Akcea Therapeutics | TTR | 1 |
| Inotuzumab ozogamicin | Ends 2031 (orphan exclusivity) | Marketed | Pfizer | CD22 | 0 |
| Isavuconazonium | Ends 2031 (exclusivity) | Marketed | Astellas | 0 | |
| Lemborexant | Ends 2031 (patent) | Marketed | Eisai | HCRTR1, HCRTR2 | 2 |
| Letermovir | Ends 2031 (exclusivity) | Marketed | Merck & Co. | 0 | |
| Letrozole | Ends 2031 (patent) | Marketed | Novartis | CYP19A1 | 1 |
| Levacetylleucine | Ends 2031 (exclusivity) | Marketed | IntraBio | F9 | 1 |
| Luspatercept | Ends 2031 (computed from the first US licence) | Marketed | Bristol Myers Squibb | TGFB1, TGFB2, TGFB3 | 3 |
| Lutetium oxodotreotide | Ends 2031 (exclusivity) | Marketed | Advanced Accelerator Applications | SSTR1, SSTR2, SSTR3 | 10 |
| Macitentan | Ends 2031 (exclusivity) | Marketed | Johnson & Johnson | EDNRA, EDNRB | 0 |
| Maralixibat | Ends 2031 (exclusivity) | Marketed | Mirum Pharmaceuticals | SLC10A2 | 2 |
| Mavorixafor | Ends 2031 (exclusivity) | Marketed | X4 Pharmaceuticals | CXCR4 | 2 |
| Niraparib | Ends 2031 (patent) | Marketed | GSK | PARP1, PARP2 | 6 |
| Nitrous acid | Ends 2031 (patent) | Marketed | Hope Biosciences | 0 | |
| Nivolumab | Ends 2031 (orphan exclusivity) | Marketed | Bristol Myers Squibb | PDCD1 | 2 |
| Onasemnogene abeparvovec | Ends 2031 (reference-product exclusivity) | Marketed | Novartis | 0 | |
| Pembrolizumab | Ends 2031 (orphan exclusivity) | Marketed | Merck & Co. | PDCD1 | 1 |
| Polatuzumab vedotin | Ends 2031 (computed from the first US licence) | Marketed | Roche | CD79B, TUBB, TUBB1 | 1 |
| Pomalidomide | Ends 2031 (patent) | Marketed | Bristol Myers Squibb | CRBN | 0 |
| Prabotulinumtoxin a | Ends 2031 (computed from the first US licence) | Marketed | Evolus | SNAP25 | 0 |
| Pretomanid | Ends 2031 (exclusivity) | Marketed | Viatris | 0 | |
| Revefenacin | Ends 2031 (patent) | Marketed | Viatris | CHRM3 | 0 |
| Ribociclib | Ends 2031 (patent) | Marketed | Novartis | CDK4, CDK6 | 2 |
| Risankizumab | Ends 2031 (computed from the first US licence) | Marketed | AbbVie | IL23A | 1 |
| Romosozumab | Ends 2031 (computed from the first US licence) | Marketed | Amgen | SOST | 2 |
| Rucaparib | Ends 2031 (patent) | Marketed | pharmaand | PARP1, PARP2, PARP3 | 5 |
| Seladelpar | Ends 2031 (exclusivity) | Marketed | Gilead Sciences | PPARD | 1 |
| Sparsentan | Ends 2031 (exclusivity) | Marketed | Retrophin | AGTR1 | 2 |
| Talazoparib | Ends 2031 (patent) | Marketed | Pfizer | PARP1, PARP2 | 2 |
| Tecovirimat | Ends 2031 (patent) | Marketed | SIGA Technologies | 0 | |
| Telotristat ethyl | Ends 2031 (patent) | Marketed | TerSera Therapeutics | TPH1, TPH2 | 4 |
| Tovorafenib | Ends 2031 (patent) | Marketed | Servier | ARAF, BRAF, RAF1 | 6 |
| Trastuzumab deruxtecan | Ends 2031 (computed from the first US licence) | Marketed | Daiichi Sankyo | ERBB2, TOP1 | 3 |
| Trifarotene | Ends 2031 (patent) | Marketed | Galderma | RARG | 2 |
| Turoctocog alfa pegol | Ends 2031 (computed from the first US licence) | Marketed | Novo Nordisk | 0 | |
| Vesicular stomatitis virus encoding ebola virus glycoprotein | Ends 2031 (reference-product exclusivity) | Marketed | Merck & Co. | 0 | |
| Vortioxetine | Ends 2031 (patent) | Marketed | Takeda | HTR1A, HTR3A, SLC6A4 | 5 |
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 2031
In the product42 of these 68 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.