US protection ending in 2034: Pregnancy and women's health
As of the edition of 20 October 2026, 25 drugs have US protection that ends in 2034 in pregnancy and women's health; 13 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
25 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Belzutifan | Ends 2034 (patent) | Marketed | Merck & Co. | EPAS1 | 1 |
| Brincidofovir | Ends 2034 (patent) | Marketed | Emergent Biosolutions | 0 | |
| Ceftobiprole medocaril free acid | Ends 2034 (exclusivity) | Marketed | Istx | 0 | |
| Ceftolozane | Ends 2034 (patent) | Marketed | Merck & Co. | 0 | |
| Ciltacabtagene autoleucel | Ends 2034 (reference-product exclusivity) | Marketed | Johnson & Johnson | TNFRSF17 | 0 |
| Daridorexant | Ends 2034 (patent) | Marketed | Idorsia Pharmaceuticals | HCRTR1, HCRTR2 | 4 |
| Deferasirox | Ends 2034 (patent) | Marketed | Novartis | 0 | |
| Fezolinetant | Ends 2034 (patent) | Marketed | Astellas | TACR3 | 1 |
| Ledipasvir | Ends 2034 (patent) | Marketed | Gilead Sciences | 0 | |
| Mirvetuximab soravtansine | Ends 2034 (computed from the first US licence) | Marketed | ImmunoGen | FOLR1 | 1 |
| Mosunetuzumab | Ends 2034 (computed from the first US licence) | Marketed | Roche | CD3D, CD3E, CD3G | 0 |
| Nadofaragene firadenovec | Ends 2034 (reference-product exclusivity) | Marketed | Ferring Pharmaceuticals | 0 | |
| Palbociclib | Ends 2034 (patent) | Marketed | Pfizer | CDK4, CDK6 | 2 |
| Relatlimab | Ends 2034 (computed from the first US licence) | Marketed | Bristol Myers Squibb | LAG3 | 1 |
| Remibrutinib | Ends 2034 (patent) | Marketed | Novartis | BTK | 1 |
| Rimegepant | Ends 2034 (patent) | Marketed | Pfizer | CALCRL | 0 |
| Ripretinib | Ends 2034 (patent) | Marketed | Deciphera Pharmaceuticals | KIT, PDGFRA | 2 |
| Semaglutide | Ends 2034 (patent) | Marketed | Novo Nordisk | GLP1R | 0 |
| Sofosbuvir | Ends 2034 (patent) | Marketed | Gilead Sciences | 0 | |
| Tazemetostat | Ends 2034 (patent) | Marketed | Ipsen | EZH2 | 2 |
| Tipiracil | Ends 2034 (patent) | Marketed | Taiho | TYMP | 1 |
| Tremelimumab | Ends 2034 (computed from the first US licence) | Marketed | AstraZeneca | CTLA4 | 1 |
| Tucatinib | Ends 2034 (patent) | Marketed | Pfizer | ERBB2 | 0 |
| Vadadustat | Ends 2034 (patent) | Marketed | Akebia Therapeutics | EGLN1, EGLN2 | 4 |
| Vibegron | Ends 2034 (patent) | Marketed | Sumitomo Pharma | ADRB3 | 2 |
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 2034 in pregnancy and women's health
In the product13 of these 25 drugs have at least one company on route B. Which companies, and their scores, are in the product.
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