US protection ending in 2032: Inherited and neonatal
As of the edition of 20 October 2026, 24 drugs have US protection that ends in 2032 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.
24 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Avutometinib | Ends 2032 (exclusivity) | Marketed | Verastem | MAP2K1, MAP2K2 | 1 |
| Baricitinib | Ends 2032 (patent) | Marketed | Eli Lilly | JAK1, JAK2 | 4 |
| Cabozantinib | Ends 2032 (exclusivity) | Marketed | Exelixis | KDR | 2 |
| Copanlisib | Ends 2032 (patent) | Marketed | Bayer | PIK3CA, PIK3CD | 2 |
| Dacomitinib anhydrous | Ends 2032 (patent) | Marketed | Pfizer | EGFR | 1 |
| Difelikefalin | Ends 2032 (patent) | Marketed | CSL Behring | OPRK1 | 2 |
| Dordaviprone | Ends 2032 (exclusivity) | Marketed | Chimerix | CLPP, DRD2 | 2 |
| Duvelisib | Ends 2032 (patent) | Marketed | Secura Bio | PIK3CD, PIK3CG | 2 |
| Elamipretide | Ends 2032 (exclusivity) | Marketed | Stealth BioTherapeutics | 0 | |
| Estradiol | Ends 2032 (patent) | Marketed | ESR1 | 6 | |
| Golimumab | Ends 2032 (orphan exclusivity) | Marketed | Johnson & Johnson | TNF | 0 |
| Leniolisib | Ends 2032 (patent) | Marketed | Pharming Technologies | PIK3CD | 1 |
| Lesinurad | Ends 2032 (patent) | Marketed | Ironwood Pharmaceuticals | SLC22A12 | 1 |
| Nilotinib | Ends 2032 (patent) | Marketed | Novartis | ABL1 | 0 |
| Osimertinib | Ends 2032 (patent) | Marketed | AstraZeneca | EGFR | 0 |
| Regorafenib | Ends 2032 (patent) | Marketed | Bayer | BRAF, FGFR1, FGFR2 | 8 |
| Satralizumab | Ends 2032 (computed from the first US licence) | Marketed | Roche | IL6R, IL6ST | 0 |
| Selumetinib | Ends 2032 (exclusivity) | Marketed | AstraZeneca | MAP2K1, MAP2K2 | 4 |
| Setmelanotide | Ends 2032 (patent) | Marketed | Rhythm Pharmaceuticals | MC4R | 1 |
| Somapacitan | Ends 2032 (computed from the first US licence) | Marketed | Novo Nordisk | GHR | 1 |
| Teprotumumab | Ends 2032 (computed from the first US licence) | Marketed | Amgen | IGF1R | 1 |
| Treosulfan | Ends 2032 (exclusivity) | Marketed | Medexus Pharma | 0 | |
| Venetoclax | Ends 2032 (patent) | Marketed | AbbVie | BCL2 | 1 |
| Vonicog alfa | Ends 2032 (orphan exclusivity) | Marketed | Takeda | 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 2032 in inherited and neonatal
In the product17 of these 24 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.