US protection ending in 2033: Pregnancy and women's health
As of the edition of 20 October 2026, 28 drugs have US protection that ends in 2033 in pregnancy and women's health; 21 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
28 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Alpelisib | Ends 2033 (patent) | Marketed | Novartis | PIK3CA | 1 |
| Amivantamab | Ends 2033 (computed from the first US licence) | Marketed | Johnson & Johnson | EGFR, MET | 1 |
| Anifrolumab | Ends 2033 (computed from the first US licence) | Marketed | AstraZeneca | IFNAR1 | 1 |
| Apalutamide | Ends 2033 (patent) | Marketed | Johnson & Johnson | AR | 0 |
| Avibactam | Ends 2033 (exclusivity) | Marketed | AbbVie | 0 | |
| Baxdrostat | Ends 2033 (patent) | Marketed | AstraZeneca | CYP11B2 | 1 |
| Binimetinib | Ends 2033 (patent) | Marketed | Pfizer | MAP2K1, MAP2K2 | 6 |
| Capivasertib | Ends 2033 (patent) | Marketed | AstraZeneca | AKT1, AKT2, AKT3 | 3 |
| Cilastatin | Ends 2033 (patent) | Marketed | Merck & Co. | DPEP1 | 1 |
| Cravacitinib | Ends 2033 (patent) | Marketed | Bristol Myers Squibb | TYK2 | 1 |
| Dostarlimab | Ends 2033 (computed from the first US licence) | Marketed | GSK | PDCD1 | 1 |
| Efgartigimod alfa | Ends 2033 (computed from the first US licence) | Marketed | argenx | FCGRT | 1 |
| Erdafitinib | Ends 2033 (patent) | Marketed | Johnson & Johnson | FGFR1, FGFR2, FGFR3 | 4 |
| Evinacumab | Ends 2033 (computed from the first US licence) | Marketed | Regeneron | ANGPTL3 | 2 |
| Ibrutinib | Ends 2033 (patent) | Marketed | AbbVie | BTK | 2 |
| Ivosidenib | Ends 2033 (patent) | Marketed | Servier | IDH1 | 0 |
| Lonapegsomatropin | Ends 2033 (computed from the first US licence) | Marketed | Ascendis Pharma A/S | GHR | 1 |
| Osilodrostat | Ends 2033 (patent) | Marketed | Recordati Rare Diseases | CYP11B1 | 0 |
| Pegcetacoplan | Ends 2033 (patent) | Marketed | Biogen | C3 | 2 |
| Pitolisant | Ends 2033 (exclusivity) | Marketed | Harmony Biosciences | HRH3 | 0 |
| Ponatinib | Ends 2033 (patent) | Marketed | Takeda | ABL1 | 1 |
| Relacorilant | Ends 2033 (patent) | Marketed | Corcept Therapeutics | NR3C1 | 1 |
| Relugolix | Ends 2033 (patent) | Marketed | Sumitomo Pharma | GNRHR | 3 |
| Resmetirom | Ends 2033 (patent) | Marketed | Madrigal Pharmaceuticals | THRB | 1 |
| Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae crm197 | Ends 2033 (reference-product exclusivity) | Marketed | Merck & Co. | 0 | |
| Tenapanor | Ends 2033 (patent) | Marketed | Ardelyx | SLC9A3 | 2 |
| Tisotumab vedotin | Ends 2033 (computed from the first US licence) | Marketed | Pfizer | F3, TUBB, TUBB1 | 11 |
| Ubrogepant | Ends 2033 (patent) | Marketed | AbbVie | CALCRL | 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 2033 in pregnancy and women's health
In the product21 of these 28 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.