US protection ending in 2037: Pregnancy and women's health
As of the edition of 20 October 2026, 13 drugs have US protection that ends in 2037 in pregnancy and women's 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.
13 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Berahyaluronidase alfa | Ends 2037 (computed from the first US licence) | Marketed | Merck & Co. | 0 | |
| Datopotamab deruxtecan | Ends 2037 (computed from the first US licence) | Marketed | Daiichi Sankyo | TACSTD2, TOP1 | 2 |
| Ensartinib | Ends 2037 (patent) | Marketed | Xcovery | ALK | 1 |
| Entrectinib | Ends 2037 (patent) | Marketed | Roche | ALK, NTRK1, NTRK2 | 4 |
| Eravacycline | Ends 2037 (patent) | Marketed | L | 0 | |
| Narsoplimab | Ends 2037 (computed from the first US licence) | Marketed | Omeros | MASP2 | 1 |
| Nipocalimab | Ends 2037 (computed from the first US licence) | Marketed | Johnson & Johnson | FCGRT | 1 |
| Orforglipron | Ends 2037 (patent) | Marketed | Eli Lilly | GLP1R | 0 |
| Penpulimab | Ends 2037 (computed from the first US licence) | Marketed | Akeso | PDCD1 | 1 |
| Piflufolastat | Ends 2037 (patent) | Marketed | Lantheus Biosciences | FOLH1 | 2 |
| Sibeprenlimab | Ends 2037 (computed from the first US licence) | Marketed | Otsuka | TNFSF13 | 1 |
| Zanubrutinib | Ends 2037 (patent) | Marketed | BeiGene | BTK | 1 |
| Zuranolone | Ends 2037 (patent) | Marketed | Biogen | 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 2037 in pregnancy and women's health
In the product9 of these 13 drugs have at least one company on route B. Which companies, and their scores, are in the product.
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