US protection ending in 2031: Mental health
As of the edition of 20 October 2026, 15 drugs have US protection that ends in 2031 in mental health; 9 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
15 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Alectinib | Ends 2031 (patent) | Marketed | Roche | ALK, RET | 1 |
| Bosutinib | Ends 2031 (exclusivity) | Marketed | Pfizer | ABL1 | 1 |
| Cabotegravir | Ends 2031 (patent) | Marketed | GSK | 0 | |
| Caplacizumab | Ends 2031 (computed from the first US licence) | Marketed | Ablynx | VWF | 1 |
| Cipepofol | Ends 2031 (exclusivity) | Marketed | Haisco-USA Pharmaceuticals | 0 | |
| Dolutegravir | Ends 2031 (patent) | Marketed | GSK | 0 | |
| Dupilumab | Ends 2031 (orphan exclusivity) | Marketed | Regeneron | IL4R | 1 |
| Elbasvir | Ends 2031 (patent) | Marketed | Merck & Co. | 0 | |
| Lemborexant | Ends 2031 (patent) | Marketed | Eisai | HCRTR1, HCRTR2 | 2 |
| Nivolumab | Ends 2031 (orphan exclusivity) | Marketed | Bristol Myers Squibb | PDCD1 | 2 |
| Pembrolizumab | Ends 2031 (orphan exclusivity) | Marketed | Merck & Co. | PDCD1 | 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 |
| Romosozumab | Ends 2031 (computed from the first US licence) | Marketed | Amgen | SOST | 2 |
| 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 mental health
In the product9 of these 15 drugs have at least one company on route B. Which companies, and their scores, are in the product.
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