US protection ending in 2035
As of the edition of 20 October 2026, 65 drugs have US protection that ends in 2035, 63 of them marketed; 28 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
65 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Apadamtase alfa | Ends 2035 (computed from the first US licence) | Marketed | Takeda | 0 | |
| Atogepant | Ends 2035 (patent) | Marketed | AbbVie | CALCRL | 0 |
| Bacillus anthracis protective antigen, adsorbed | Ends 2035 (computed from the first US licence) | Marketed | Emergent Product Development Gaithersburg, Inc. | 0 | |
| Beremagene geperpavec | Ends 2035 (computed from the first US licence) | Marketed | Krystal Biotech | 0 | |
| Bictegravir | Ends 2035 (patent) | Marketed | Gilead Sciences | 0 | |
| Bimekizumab | Ends 2035 (computed from the first US licence) | Marketed | UCB | IL17A, IL17F | 2 |
| Brensocatib | Ends 2035 (patent) | Marketed | Insmed | CTSC | 1 |
| Brigatinib | Ends 2035 (patent) | Marketed | Takeda | ALK, EGFR | 1 |
| Cefiderocol | Ends 2035 (patent) | Marketed | Shionogi | 0 | |
| Chikungunya virus, live attenuated | Ends 2035 (computed from the first US licence) | Marketed | Valneva | 0 | |
| Cipaglucosidase alfa | Ends 2035 (computed from the first US licence) | Marketed | Amicus Therapeutics | IGF2R | 1 |
| Danicopan | Ends 2035 (patent) | Marketed | AstraZeneca | CFD | 1 |
| Dasiglucagon hydrochloride | Ends 2035 (patent) | Marketed | Zealand Pharma | GCGR | 1 |
| Delandistrogene moxeparvovec | Ends 2035 (reference-product exclusivity) | Marketed | Avi Biopharma | 0 | |
| Donidalorsen sodium | Ends 2035 (patent) | Marketed | Akcea Therapeutics | 0 | |
| Donislecel | Ends 2035 (computed from the first US licence) | Marketed | CellTrans | 0 | |
| Efanesoctocog alfa | Ends 2035 (computed from the first US licence) | Marketed | Bioverativ Therapeutics | 0 | |
| Efbemalenograstim alfa | Ends 2035 (computed from the first US licence) | Marketed | Evive Biotechnology | CSF3R | 2 |
| Elranatamab | Ends 2035 (computed from the first US licence) | Marketed | Pfizer | CD3E, TNFRSF17 | 1 |
| Epcoritamab | Ends 2035 (computed from the first US licence) | Marketed | Merus | CD3D, CD3E, CD3G | 2 |
| Exagamglogene autotemcel | Ends 2035 (computed from the first US licence) | Marketed | Vertex | BCL11A | 1 |
| Fecal microbiota spores, live | Ends 2035 (reference-product exclusivity) | Marketed | Aimmune Therapeutics | 0 | |
| Ferric maltol | Ends 2035 (patent) | Marketed | Shield Tx | 0 | |
| Finerenone | Ends 2035 (patent) | Marketed | Bayer | NR3C2 | 0 |
| Florquinitau | Ends 2035 (patent) | Marketed | CERVEAU TECHNOLOGIES INC A LANTHEUS CO | MAPT | 0 |
| Foscarbidopa | Ends 2035 (patent) | Marketed | AbbVie | DDC | 0 |
| Fruquintinib | Ends 2035 (patent) | Marketed | Takeda | FLT1, FLT4, KDR | 2 |
| Glecaprevir | Ends 2035 (patent) | Marketed | AbbVie | 0 | |
| Glofitamab | Ends 2035 (computed from the first US licence) | Marketed | Roche | CD3E, MS4A1 | 0 |
| Ibrexafungerp | Ends 2035 (patent) | Marketed | GSK | 0 | |
| Lecanemab | Ends 2035 (computed from the first US licence) | Marketed | Eisai | APP | 1 |
| Lenvatinib | Ends 2035 (patent) | Marketed | Eisai | FLT1, FLT4, KDR | 3 |
| Lovotibeglogene autotemcel | Ends 2035 (computed from the first US licence) | Marketed | Bluebird Bio | 0 | |
| Mirikizumab | Ends 2035 (computed from the first US licence) | Marketed | Eli Lilly | IL23A | 1 |
| Mobocertinib | Ends 2035 (patent) | Marketed | Takeda | EGFR | 0 |
| Momelotinib | Ends 2035 (patent) | Marketed | GSK | ACVR1, JAK1, JAK2 | 3 |
| Netupitant | Ends 2035 (patent) | Marketed | Helsinn Healthcare | TACR1 | 0 |
| Nirsevimab | Ends 2035 (computed from the first US licence) | Marketed | Sanofi | 0 | |
| Omidenepag isopropyl | Ends 2035 (patent) | Marketed | Ocuvex Therapeutics | PTGER2 | 1 |
| Omidubicel | Ends 2035 (computed from the first US licence) | Marketed | Gamida Cell | 0 | |
| Oritavancin | Ends 2035 (patent) | Marketed | Melinta Therapeutics | 0 | |
| Pafolacianine | Ends 2035 (patent) | Marketed | On Target | FOLR1 | 1 |
| Patisiran sodium | Ends 2035 (patent) | Marketed | Alnylam Pharmaceuticals | TTR | 0 |
| Pegunigalsidase alfa | Ends 2035 (computed from the first US licence) | Marketed | Chiesi Farmaceutici | 0 | |
| Perflutren | Ends 2035 (patent) | Marketed | Lantheus Medical Imaging | 0 | |
| Pozelimab | Ends 2035 (computed from the first US licence) | Marketed | Regeneron | C5 | 1 |
| Remdesivir | Ends 2035 (patent) | Marketed | Gilead Sciences | 0 | |
| Respiratory syncytial virus pre-fusion glycoprotein f | Ends 2035 (reference-product exclusivity) | Marketed | GSK | 0 | |
| Retifanlimab | Ends 2035 (computed from the first US licence) | Marketed | Incyte | PDCD1 | 1 |
| Rozanolixizumab | Ends 2035 (computed from the first US licence) | Marketed | UCB | FCGRT | 1 |
| Selinexor | Ends 2035 (patent) | Marketed | Karyopharm Therapeutics | XPO1 | 2 |
| Sodium zirconium cyclosilicate | Ends 2035 (patent) | Marketed | AstraZeneca | 0 | |
| Somatrogon | Ends 2035 (computed from the first US licence) | Marketed | Pfizer | GHR | 0 |
| Tafamidis | Ends 2035 (patent) | Marketed | Pfizer | TTR | 1 |
| Talquetamab | Ends 2035 (computed from the first US licence) | Marketed | Johnson & Johnson | CD3D, CD3E, CD3G | 1 |
| Tasimelteon | Ends 2035 (patent) | Marketed | Vanda Pharmaceuticals | MTNR1A, MTNR1B | 2 |
| Tofersen | Ends 2035 (patent) | Marketed | Biogen | SOD1 | 1 |
| Toripalimab | Ends 2035 (computed from the first US licence) | Marketed | Coherus Oncology | PDCD1 | 2 |
| Umbralisib | Ends 2035 (patent) | Withdrawn from market | TG Therapeutics | ABL1, PIK3CD | 0 |
| Valoctocogene roxaparvovec | Ends 2035 (computed from the first US licence) | Marketed | Amicus Therapeutics | 0 | |
| Velmanase alfa | Ends 2035 (computed from the first US licence) | Marketed | Chiesi Farmaceutici | 0 | |
| Vosoritide | Ends 2035 (patent) | Marketed | Amicus Therapeutics | NPR2 | 1 |
| Voxelotor | Ends 2035 (patent) | Withdrawn from market | Pfizer | HBA1 | 0 |
| Zilucoplan sodium | Ends 2035 (patent) | Marketed | UCB | C5 | 1 |
| Zoliflodacin | Ends 2035 (exclusivity) | Marketed | Entasis Therapeutics | 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 the product28 of these 65 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.