US protection ending in 2033
As of the edition of 20 October 2026, 52 drugs have US protection that ends in 2033; 33 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
52 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Aducanumab | Ends 2033 (computed from the first US licence) | Marketed | Biogen | APP | 1 |
| 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 |
| Avalglucosidase alfa | Ends 2033 (computed from the first US licence) | Marketed | Sanofi | 0 | |
| Avibactam | Ends 2033 (exclusivity) | Marketed | AbbVie | 0 | |
| Axicabtagene ciloleucel | Ends 2033 (orphan exclusivity) | Marketed | Gilead Sciences | CD19 | 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 |
| Copper histidine | Ends 2033 (exclusivity) | Marketed | Sentynl Therapeutics | 0 | |
| Cravacitinib | Ends 2033 (patent) | Marketed | Bristol Myers Squibb | TYK2 | 1 |
| Diroximel fumarate | Ends 2033 (patent) | Marketed | Biogen | KEAP1 | 0 |
| Dostarlimab | Ends 2033 (computed from the first US licence) | Marketed | GSK | PDCD1 | 1 |
| Durlobactam | Ends 2033 (exclusivity) | Marketed | Entasis Therapeutics | 0 | |
| 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 |
| Fitusiran | Ends 2033 (patent) | Marketed | Sanofi | SERPINC1 | 0 |
| Ibrutinib | Ends 2033 (patent) | Marketed | AbbVie | BTK | 2 |
| Idecabtagene vicleucel | Ends 2033 (computed from the first US licence) | Marketed | Bristol Myers Squibb | TNFRSF17 | 1 |
| Idelalisib | Ends 2033 (patent) | Marketed | Gilead Sciences | PIK3CD | 1 |
| Ivosidenib | Ends 2033 (patent) | Marketed | Servier | IDH1 | 0 |
| Lefamulin | Ends 2033 (patent) | Marketed | Hong Kong King Friend Industrial | 0 | |
| Linerixibat | Ends 2033 (exclusivity) | Marketed | Alfasigma | SLC10A2 | 1 |
| Lisocabtagene maraleucel | Ends 2033 (computed from the first US licence) | Marketed | Juno Therapeutics | CD19 | 2 |
| Lonapegsomatropin | Ends 2033 (computed from the first US licence) | Marketed | Ascendis Pharma A/S | GHR | 1 |
| Loncastuximab tesirine | Ends 2033 (computed from the first US licence) | Marketed | ADC Therapeutics | CD19 | 2 |
| Luliconazole | Ends 2033 (patent) | Marketed | Bausch Health | 0 | |
| Naldemedine | Ends 2033 (patent) | Marketed | Collegium Pharmaceutical | OPRM1 | 1 |
| Obeticholic acid | Ends 2033 (patent) | Marketed | Alfasigma | NR1H4 | 1 |
| Omaveloxolone | Ends 2033 (patent) | Marketed | Biogen | NFE2L2 | 1 |
| Omega-3-carboxylic acids | Ends 2033 (patent) | Marketed | AstraZeneca | 0 | |
| 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 |
| Ropeginterferon alfa-2b | Ends 2033 (computed from the first US licence) | Marketed | PharmaEssentia | IFNAR1, IFNAR2 | 0 |
| Sarecycline | Ends 2033 (patent) | Marketed | Almirall | 0 | |
| Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae crm197 | Ends 2033 (reference-product exclusivity) | Marketed | Merck & Co. | 0 | |
| Taletrectinib | Ends 2033 (patent) | Marketed | Nuvation Bio | NTRK1, NTRK2, NTRK3 | 8 |
| Tenapanor | Ends 2033 (patent) | Marketed | Ardelyx | SLC9A3 | 2 |
| Tezepelumab | Ends 2033 (computed from the first US licence) | Marketed | AstraZeneca | TSLP | 1 |
| Tisotumab vedotin | Ends 2033 (computed from the first US licence) | Marketed | Pfizer | F3, TUBB, TUBB1 | 11 |
| Tozinameran | Ends 2033 (computed from the first US licence) | Marketed | BioNTech Manufacturing GmbH | 0 | |
| Tralokinumab | Ends 2033 (computed from the first US licence) | Marketed | LEO Pharma | IL13 | 1 |
| 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 the product33 of these 52 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.