US protection ending in 2027
As of the edition of 20 October 2026, 59 drugs have US protection that ends in 2027; 26 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
59 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Anakinra | Ends 2027 (orphan exclusivity) | Marketed | Swedish Orphan Biovitrum | IL1R1 | 0 |
| Antihemophilic factor, pegylated (mw 20000) human sequence recombinant | Ends 2027 (computed from the first US licence) | Marketed | Takeda | 0 | |
| Artesunate | Ends 2027 (exclusivity) | Marketed | Amivas | 0 | |
| Asfotase alfa | Ends 2027 (computed from the first US licence) | Marketed | AstraZeneca | 0 | |
| Avacincaptad pegol sodium | Ends 2027 (patent) | Marketed | Astellas | C5 | 1 |
| Bazedoxifene | Ends 2027 (patent) | Marketed | Pfizer | ESR1, ESR2 | 0 |
| Bevacizumab | Ends 2027 (orphan exclusivity) | Marketed | Roche | VEGFA | 2 |
| Canakinumab | Ends 2027 (orphan exclusivity) | Marketed | Novartis | IL1B | 1 |
| Copper oxodotreotide | Ends 2027 (exclusivity) | Marketed | Curium | SSTR2 | 1 |
| Desvenlafaxine | Ends 2027 (patent) | Marketed | Pfizer | SLC6A4 | 0 |
| Dinutuximab | Ends 2027 (computed from the first US licence) | Marketed | United Therapeutics | 0 | |
| Edoxaban | Ends 2027 (patent) | Marketed | Daiichi Sankyo | F10 | 1 |
| Elotuzumab | Ends 2027 (computed from the first US licence) | Marketed | Bristol Myers Squibb | SLAMF7 | 0 |
| Enzalutamide | Ends 2027 (patent) | Marketed | Astellas | AR | 1 |
| Ferric carboxymaltose | Ends 2027 (patent) | Marketed | American Regent | 0 | |
| Fidaxomicin | Ends 2027 (patent) | Marketed | Merck & Co. | 0 | |
| Florbetapir | Ends 2027 (patent) | Marketed | Avid Radiopharmaceuticals | 0 | |
| Fluticasone furoate | Ends 2027 (patent) | Marketed | GSK | NR3C1 | 0 |
| Fomepizole | Ends 2027 (patent) | Marketed | Endo | ADH1A, ADH1B, ADH1C | 3 |
| Fostemsavir | Ends 2027 (patent) | Marketed | GSK | 0 | |
| Idarucizumab | Ends 2027 (computed from the first US licence) | Marketed | Boehringer Ingelheim | 0 | |
| Iloperidone | Ends 2027 (exclusivity) | Marketed | Vanda Pharmaceuticals | HTR2A | 1 |
| Insulin degludec | Ends 2027 (computed from the first US licence) | Marketed | Novo Nordisk | INSR | 0 |
| Ipilimumab | Ends 2027 (orphan exclusivity) | Marketed | Bristol Myers Squibb | CTLA4 | 1 |
| Lenalidomide | Ends 2027 (patent) | Marketed | Bristol Myers Squibb | CRBN | 0 |
| Lonafarnib | Ends 2027 (exclusivity) | Marketed | Sentynl Therapeutics | FNTA, FNTB | 3 |
| Malathion | Ends 2027 (patent) | Marketed | Taro Pharmaceutical Industries | 0 | |
| Mepolizumab | Ends 2027 (computed from the first US licence) | Marketed | GSK | IL5 | 0 |
| Mesalamine | Ends 2027 (patent) | Marketed | Viatris | PPARG, PTGS1, PTGS2 | 12 |
| Methylene blue cation | Ends 2027 (exclusivity) | Marketed | Provepharm | GUCY1A1, GUCY1A2, GUCY1B1 | 1 |
| Mipomersen | Ends 2027 (patent) | Marketed | Kastle Therapeutics | APOB | 1 |
| Necitumumab | Ends 2027 (computed from the first US licence) | Marketed | Eli Lilly | EGFR | 0 |
| Nifurtimox | Ends 2027 (exclusivity) | Marketed | Bayer | 0 | |
| Nintedanib | Ends 2027 (exclusivity) | Marketed | Boehringer Ingelheim | FGFR1, FGFR2, FGFR3 | 9 |
| Olive oil | Ends 2027 (exclusivity) | Marketed | Baxter Healthcare | 0 | |
| Olodaterol | Ends 2027 (patent) | Marketed | Boehringer Ingelheim | ADRB2 | 0 |
| Pantoprazole | Ends 2027 (exclusivity) | Marketed | Pfizer | ATP4A | 1 |
| Parathyroid hormone | Ends 2027 (computed from the first US licence) | Marketed | Takeda | PTH1R | 1 |
| Rasagiline | Ends 2027 (patent) | Marketed | Teva | MAOB | 2 |
| Regadenoson anhydrous | Ends 2027 (patent) | Marketed | Astellas | ADORA2A | 2 |
| Retapamulin | Ends 2027 (patent) | Marketed | Almirall | 0 | |
| Rifaximin | Ends 2027 (patent) | Marketed | Bausch Health | 0 | |
| Rilpivirine | Ends 2027 (exclusivity) | Marketed | Johnson & Johnson | 0 | |
| Sacubitril | Ends 2027 (patent) | Marketed | Novartis | MME | 1 |
| Saxagliptin anhydrous | Ends 2027 (exclusivity) | Marketed | AstraZeneca | DPP4 | 2 |
| Sebelipase alfa | Ends 2027 (computed from the first US licence) | Marketed | AstraZeneca | 0 | |
| Secnidazole | Ends 2027 (exclusivity) | Marketed | Neothetics | 0 | |
| Secukinumab | Ends 2027 (computed from the first US licence) | Marketed | Novartis | IL17A | 1 |
| Simoctocog alfa | Ends 2027 (computed from the first US licence) | Marketed | Octapharma Pharmazeutika Produktionsges.m.b.H | 0 | |
| Sorafenib | Ends 2027 (patent) | Marketed | Bayer | BRAF, FLT1, FLT3 | 1 |
| Talimogene laherparepvec | Ends 2027 (computed from the first US licence) | Marketed | Amgen | 0 | |
| Tapentadol | Ends 2027 (exclusivity) | Marketed | Collegium Pharmaceutical | OPRM1, SLC6A2 | 4 |
| Telavancin | Ends 2027 (patent) | Marketed | Apotex | 0 | |
| Trenonacog alfa | Ends 2027 (computed from the first US licence) | Marketed | Medexus Pharma | 0 | |
| Triheptanoin | Ends 2027 (exclusivity) | Marketed | Ultragenyx Pharmaceutical | 0 | |
| Umeclidinium | Ends 2027 (patent) | Marketed | GSK | CHRM3 | 0 |
| Voclosporin | Ends 2027 (patent) | Marketed | Aurinia Pharmaceuticals | PPP3CA | 2 |
| Vorapaxar | Ends 2027 (patent) | Marketed | Merck & Co. | F2R | 1 |
| Vorinostat | Ends 2027 (patent) | Marketed | Merck & Co. | HDAC1, HDAC2, HDAC3 | 4 |
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 2027
In the product26 of these 59 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.