US protection ending in 2029: Inherited and neonatal
As of the edition of 20 October 2026, 33 drugs have US protection that ends in 2029 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.
33 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Afatinib | Ends 2029 (patent) | Marketed | Boehringer Ingelheim | EGFR | 1 |
| Amifampridine | Ends 2029 (exclusivity) | Marketed | Angelini Pharma | 0 | |
| Atezolizumab | Ends 2029 (orphan exclusivity) | Marketed | Roche | CD274 | 1 |
| Avelumab | Ends 2029 (computed from the first US licence) | Marketed | Merck KGaA | CD274 | 1 |
| Azacitidine | Ends 2029 (exclusivity) | Marketed | Bristol Myers Squibb | DNMT1, DNMT3A | 4 |
| Bendamustine | Ends 2029 (patent) | Marketed | Teva | 0 | |
| Berdazimer sodium | Ends 2029 (exclusivity) | Marketed | Lnhc | 0 | |
| Budesonide | Ends 2029 (exclusivity) | Marketed | NR3C1 | 5 | |
| Canagliflozin anhydrous | Ends 2029 (patent) | Marketed | Johnson & Johnson | SLC5A2 | 2 |
| Crisaborole | Ends 2029 (patent) | Marketed | Pfizer | PDE4A, PDE4B, PDE4C | 0 |
| Crizotinib | Ends 2029 (patent) | Marketed | Pfizer | ALK, MET, ROS1 | 2 |
| Dapagliflozin | Ends 2029 (patent) | Marketed | AstraZeneca | SLC5A2 | 2 |
| Edaravone | Ends 2029 (exclusivity) | Marketed | Shionogi | 0 | |
| Emicizumab | Ends 2029 (computed from the first US licence) | Marketed | Roche | F10, F9 | 2 |
| Etonogestrel | Ends 2029 (exclusivity) | Marketed | Organon | PGR | 1 |
| Florbetaben | Ends 2029 (patent) | Marketed | Lantheus Biosciences | 0 | |
| Ganaxolone | Ends 2029 (exclusivity) | Marketed | Immedica Pharma | 0 | |
| Gemtuzumab ozogamicin | Ends 2029 (computed from the first US licence) | Marketed | Pfizer | CD33 | 0 |
| Guselkumab | Ends 2029 (computed from the first US licence) | Marketed | Johnson & Johnson | IL23A | 1 |
| Infigratinib | Ends 2029 (patent) | Marketed | Helsinn Healthcare | FGFR1, FGFR2, FGFR3 | 4 |
| Ixazomib citrate | Ends 2029 (patent) | Marketed | Takeda | PSMB5 | 0 |
| Lapatinib | Ends 2029 (patent) | Marketed | Novartis | EGFR | 2 |
| Linaclotide | Ends 2029 (exclusivity) | Marketed | AbbVie | GUCY2C | 3 |
| Lomitapide | Ends 2029 (exclusivity) | Marketed | Chiesi Farmaceutici | MTTP | 1 |
| Nitric oxide | Ends 2029 (patent) | Marketed | Byk-Mallinckrodt CIL | GUCY1B1, GUCY1B2 | 4 |
| Nonacog beta pegol | Ends 2029 (computed from the first US licence) | Marketed | Novo Nordisk | 0 | |
| Oxymorphone | Ends 2029 (patent) | Marketed | Endo | OPRD1, OPRK1, OPRM1 | 0 |
| Phenobarbital | Ends 2029 (exclusivity) | Marketed | SUN Pharmaceutical Industries | 0 | |
| Posaconazole | Ends 2029 (exclusivity) | Marketed | Merck & Co. | 0 | |
| Ruxolitinib | Ends 2029 (exclusivity) | Marketed | JAK1, JAK2 | 4 | |
| Stiripentol | Ends 2029 (exclusivity) | Marketed | Biocodex | 0 | |
| Vestronidase alfa | Ends 2029 (computed from the first US licence) | Marketed | Ultragenyx Pharamceutical | 0 | |
| Voretigene neparvovec | Ends 2029 (computed from the first US licence) | Marketed | Roche | 0 |
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 2029 in inherited and neonatal
In the product17 of these 33 drugs have at least one company on route B. Which companies, and their scores, are in the product.
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