US protection ending in 2035: Pregnancy and women's health
As of the edition of 20 October 2026, 24 drugs have US protection that ends in 2035 in pregnancy and women's health, 23 of them marketed; 12 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 |
|---|---|---|---|---|---|
| Atogepant | Ends 2035 (patent) | Marketed | AbbVie | CALCRL | 0 |
| Brensocatib | Ends 2035 (patent) | Marketed | Insmed | CTSC | 1 |
| Cefiderocol | Ends 2035 (patent) | Marketed | Shionogi | 0 | |
| Danicopan | Ends 2035 (patent) | Marketed | AstraZeneca | CFD | 1 |
| Efbemalenograstim alfa | Ends 2035 (computed from the first US licence) | Marketed | Evive Biotechnology | CSF3R | 2 |
| Exagamglogene autotemcel | Ends 2035 (computed from the first US licence) | Marketed | Vertex | BCL11A | 1 |
| Ferric maltol | Ends 2035 (patent) | Marketed | Shield Tx | 0 | |
| Finerenone | Ends 2035 (patent) | Marketed | Bayer | NR3C2 | 0 |
| Fruquintinib | Ends 2035 (patent) | Marketed | Takeda | FLT1, FLT4, KDR | 2 |
| Glecaprevir | Ends 2035 (patent) | Marketed | AbbVie | 0 | |
| Ibrexafungerp | Ends 2035 (patent) | Marketed | GSK | 0 | |
| Lenvatinib | Ends 2035 (patent) | Marketed | Eisai | FLT1, FLT4, KDR | 3 |
| Mobocertinib | Ends 2035 (patent) | Marketed | Takeda | EGFR | 0 |
| Netupitant | Ends 2035 (patent) | Marketed | Helsinn Healthcare | TACR1 | 0 |
| Pafolacianine | Ends 2035 (patent) | Marketed | On Target | FOLR1 | 1 |
| Pegunigalsidase alfa | Ends 2035 (computed from the first US licence) | Marketed | Chiesi Farmaceutici | 0 | |
| Perflutren | Ends 2035 (patent) | Marketed | Lantheus Medical Imaging | 0 | |
| Retifanlimab | Ends 2035 (computed from the first US licence) | Marketed | Incyte | PDCD1 | 1 |
| Selinexor | Ends 2035 (patent) | Marketed | Karyopharm Therapeutics | XPO1 | 2 |
| Sodium zirconium cyclosilicate | Ends 2035 (patent) | Marketed | AstraZeneca | 0 | |
| Tasimelteon | Ends 2035 (patent) | Marketed | Vanda Pharmaceuticals | MTNR1A, MTNR1B | 2 |
| Toripalimab | Ends 2035 (computed from the first US licence) | Marketed | Coherus Oncology | PDCD1 | 2 |
| Vosoritide | Ends 2035 (patent) | Marketed | Amicus Therapeutics | NPR2 | 1 |
| Voxelotor | Ends 2035 (patent) | Withdrawn from market | Pfizer | HBA1 | 0 |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 2035 in pregnancy and women's health
In the product12 of these 24 drugs have at least one company on route B. Which companies, and their scores, are in the product.
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