US protection ending in 2027: Inherited and neonatal
As of the edition of 20 October 2026, 32 drugs have US protection that ends in 2027 in inherited and neonatal; 17 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
32 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 | |
| Bevacizumab | Ends 2027 (orphan exclusivity) | Marketed | Roche | VEGFA | 2 |
| Canakinumab | Ends 2027 (orphan exclusivity) | Marketed | Novartis | IL1B | 1 |
| Enzalutamide | Ends 2027 (patent) | Marketed | Astellas | AR | 1 |
| Ferric carboxymaltose | Ends 2027 (patent) | Marketed | American Regent | 0 | |
| Florbetapir | Ends 2027 (patent) | Marketed | Avid Radiopharmaceuticals | 0 | |
| Fomepizole | Ends 2027 (patent) | Marketed | Endo | ADH1A, ADH1B, ADH1C | 3 |
| 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 |
| 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 |
| Nintedanib | Ends 2027 (exclusivity) | Marketed | Boehringer Ingelheim | FGFR1, FGFR2, FGFR3 | 9 |
| Pantoprazole | Ends 2027 (exclusivity) | Marketed | Pfizer | ATP4A | 1 |
| Regadenoson anhydrous | Ends 2027 (patent) | Marketed | Astellas | ADORA2A | 2 |
| Retapamulin | Ends 2027 (patent) | Marketed | Almirall | 0 | |
| Rifaximin | Ends 2027 (patent) | Marketed | Bausch Health | 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 | |
| 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 | |
| Telavancin | Ends 2027 (patent) | Marketed | Apotex | 0 | |
| Triheptanoin | Ends 2027 (exclusivity) | Marketed | Ultragenyx Pharmaceutical | 0 | |
| 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 inherited and neonatal
In the product17 of these 32 drugs have at least one company on route B. Which companies, and their scores, are in the product.
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