US protection ending in 2034
As of the edition of 20 October 2026, 52 drugs have US protection that ends in 2034; 28 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 |
|---|---|---|---|---|---|
| Belumosudil | Ends 2034 (patent) | Marketed | Sanofi | ROCK1, ROCK2 | 4 |
| Belzutifan | Ends 2034 (patent) | Marketed | Merck & Co. | EPAS1 | 1 |
| Betibeglogene autotemcel | Ends 2034 (reference-product exclusivity) | Marketed | Bluebird Bio | 0 | |
| Brincidofovir | Ends 2034 (patent) | Marketed | Emergent Biosolutions | 0 | |
| Cedazuridine | Ends 2034 (patent) | Marketed | Taiho | CDA | 1 |
| 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 |
| Daxibotulinumtoxina | Ends 2034 (computed from the first US licence) | Marketed | Crown | SNAP25 | 1 |
| Deferasirox | Ends 2034 (patent) | Marketed | Novartis | 0 | |
| Eflapegrastim | Ends 2034 (computed from the first US licence) | Marketed | Zydus Worldwide DMCC | CSF3R | 1 |
| Elivaldogene autotemcel | Ends 2034 (reference-product exclusivity) | Marketed | Bluebird Bio | 0 | |
| Enasidenib | Ends 2034 (patent) | Marketed | Bristol Myers Squibb | IDH2 | 1 |
| Eplontersen sodium | Ends 2034 (patent) | Marketed | AstraZeneca | TTR | 1 |
| Etranacogene dezaparvovec | Ends 2034 (reference-product exclusivity) | Marketed | CSL Behring | 0 | |
| Faricimab | Ends 2034 (computed from the first US licence) | Marketed | Roche | ANGPT2, VEGFA | 1 |
| Fezolinetant | Ends 2034 (patent) | Marketed | Astellas | TACR3 | 1 |
| Givosiran sodium | Ends 2034 (patent) | Marketed | Alnylam Pharmaceuticals | ALAS1 | 1 |
| Inclisiran sodium | Ends 2034 (patent) | Marketed | Novartis | PCSK9 | 0 |
| 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 | |
| Netarsudil | Ends 2034 (patent) | Marketed | Alcon | ROCK1, ROCK2 | 6 |
| Olezarsen sodium | Ends 2034 (patent) | Marketed | Akcea Therapeutics | APOC3 | 0 |
| Olipudase alfa | Ends 2034 (computed from the first US licence) | Marketed | Sanofi | 0 | |
| Palbociclib | Ends 2034 (patent) | Marketed | Pfizer | CDK4, CDK6 | 2 |
| Pegulicianine acetate | Ends 2034 (patent) | Marketed | Lumicell | 0 | |
| Plecanatide | Ends 2034 (patent) | Marketed | Bausch Health | GUCY2C | 1 |
| 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 |
| Riociguat | Ends 2034 (patent) | Marketed | Bayer | GUCY1A1, GUCY1A2, GUCY1B1 | 1 |
| 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 | |
| Spesolimab | Ends 2034 (computed from the first US licence) | Marketed | LEO Pharma | IL1RL2 | 0 |
| Stem bromelain | Ends 2034 (computed from the first US licence) | Marketed | Vericel | 0 | |
| Sutimlimab | Ends 2034 (computed from the first US licence) | Marketed | Recordati Rare Diseases | C1S | 2 |
| Tazemetostat | Ends 2034 (patent) | Marketed | Ipsen | EZH2 | 2 |
| Tebentafusp | Ends 2034 (computed from the first US licence) | Marketed | Immunocore | PMEL | 1 |
| Teclistamab | Ends 2034 (computed from the first US licence) | Marketed | Johnson & Johnson | CD3D, CD3E, CD3G | 0 |
| Teplizumab | Ends 2034 (computed from the first US licence) | Marketed | Sanofi | CD3E | 1 |
| 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 |
| Ublituximab | Ends 2034 (computed from the first US licence) | Marketed | TG Therapeutics | MS4A1 | 2 |
| Vadadustat | Ends 2034 (patent) | Marketed | Akebia Therapeutics | EGLN1, EGLN2 | 4 |
| Vibegron | Ends 2034 (patent) | Marketed | Sumitomo Pharma | ADRB3 | 2 |
| Viltolarsen | Ends 2034 (patent) | Marketed | Nippon Shinyaku | DMD | 0 |
| Zavegepant | Ends 2034 (patent) | Marketed | Pfizer | 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 2034
In the product28 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.