US protection ending in 2036
As of the edition of 20 October 2026, 44 drugs have US protection that ends in 2036; 30 of them have at least one company on route B because of it.
Sources: FDA Orange Book and Purple Book, other approval registers.
44 drugs
| Drug | US protection | Status | Holder | Target | Route B rows |
|---|---|---|---|---|---|
| Abrocitinib | Ends 2036 (patent) | Marketed | Pfizer | JAK1 | 0 |
| Acalabrutinib | Ends 2036 (patent) | Marketed | AstraZeneca | BTK | 1 |
| Afamitresgene autoleucel | Ends 2036 (reference-product exclusivity) | Marketed | Uswm Ct | MAGEA4 | 1 |
| Atidarsagene autotemcel | Ends 2036 (reference-product exclusivity) | Marketed | Kyowa Kirin | 0 | |
| Axatilimab | Ends 2036 (computed from the first US licence) | Marketed | Incyte | CSF1R | 1 |
| Cobimetinib | Ends 2036 (patent) | Marketed | Roche | MAP2K1 | 1 |
| Concizumab | Ends 2036 (computed from the first US licence) | Marketed | Novo Nordisk | TFPI | 1 |
| Cosibelimab | Ends 2036 (computed from the first US licence) | Marketed | SUN Pharmaceutical Industries | CD274 | 1 |
| Crovalimab | Ends 2036 (computed from the first US licence) | Marketed | Roche | C5 | 1 |
| Difamilast | Ends 2036 (patent) | Marketed | Acrotech Biopharma | PDE4A, PDE4B, PDE4C | 4 |
| Donanemab | Ends 2036 (computed from the first US licence) | Marketed | Eli Lilly | APP | 1 |
| Eladocagene exuparvovec | Ends 2036 (computed from the first US licence) | Marketed | PTC Therapeutics | 0 | |
| Etrasimod | Ends 2036 (patent) | Marketed | Pfizer | S1PR1 | 1 |
| Fenfluramine | Ends 2036 (patent) | Marketed | UCB | HTR1D, HTR2C, SIGMAR1 | 3 |
| Fidanacogene elaparvovec | Ends 2036 (reference-product exclusivity) | Marketed | Pfizer | 0 | |
| Futibatinib | Ends 2036 (patent) | Marketed | Taiho | FGFR1, FGFR2, FGFR3 | 4 |
| Gadoquatrane | Ends 2036 (patent) | Marketed | Bayer | 0 | |
| Glasdegib | Ends 2036 (patent) | Marketed | Pfizer | SMO | 1 |
| Larotrectinib | Ends 2036 (patent) | Marketed | Bayer | NTRK1, NTRK2, NTRK3 | 3 |
| Lebrikizumab | Ends 2036 (computed from the first US licence) | Marketed | Eli Lilly | IL13 | 1 |
| Letibotulinumtoxina | Ends 2036 (computed from the first US licence) | Marketed | Hugel | SNAP25 | 1 |
| Lifileucel | Ends 2036 (reference-product exclusivity) | Marketed | Iovance Biotherapeutics | 0 | |
| Marstacimab | Ends 2036 (computed from the first US licence) | Marketed | Pfizer | TFPI | 1 |
| Mavacamten | Ends 2036 (patent) | Marketed | Bristol Myers Squibb | MYH7 | 0 |
| Nemolizumab | Ends 2036 (computed from the first US licence) | Marketed | Galderma | IL31RA | 2 |
| Nogapendekin alfa inbakicept | Ends 2036 (computed from the first US licence) | Marketed | Altor BioScience | IL15RA, IL2RB, IL2RG | 0 |
| Obecabtagene autoleucel | Ends 2036 (reference-product exclusivity) | Marketed | Autolus | CD19 | 1 |
| Oteseconazole | Ends 2036 (patent) | Marketed | Mycovia Pharmaceuticals | 0 | |
| Pexidartinib | Ends 2036 (patent) | Marketed | Daiichi Sankyo | CSF1R, FLT3, KIT | 0 |
| Pirtobrutinib | Ends 2036 (patent) | Marketed | Eli Lilly | BTK | 1 |
| Remestemcel-l | Ends 2036 (computed from the first US licence) | Marketed | Mesoblast | 0 | |
| Repotrectinib | Ends 2036 (patent) | Marketed | Bristol Myers Squibb | NTRK2, NTRK3, ROS1 | 3 |
| Respiratory syncytial virus pre-fusion glycoprotein f mrna | Ends 2036 (reference-product exclusivity) | Marketed | ModernaTX | 0 | |
| Sonidegib | Ends 2036 (patent) | Marketed | SUN Pharmaceutical Industries | SMO | 0 |
| Sotatercept | Ends 2036 (computed from the first US licence) | Marketed | Merck & Co. | INHBA | 1 |
| Tarlatamab | Ends 2036 (computed from the first US licence) | Marketed | Amgen | CD3D, CD3E, CD3G | 1 |
| Tislelizumab | Ends 2036 (computed from the first US licence) | Marketed | BeiGene | PDCD1 | 2 |
| Upadacitinib | Ends 2036 (patent) | Marketed | AbbVie | JAK1, JAK2, JAK3 | 3 |
| Valbenazine | Ends 2036 (patent) | Marketed | Neurocrine | SLC18A2 | 2 |
| Vipivotide tetraxetan lutetium | Ends 2036 (patent) | Marketed | Novartis | FOLH1 | 1 |
| Vutrisiran sodium | Ends 2036 (patent) | Marketed | Alnylam Pharmaceuticals | TTR | 0 |
| Zanidatamab | Ends 2036 (computed from the first US licence) | Marketed | Jazz Pharmaceuticals | ERBB2 | 1 |
| Zenocutuzumab | Ends 2036 (computed from the first US licence) | Marketed | Merus | ERBB2, ERBB3 | 2 |
| Zolbetuximab | Ends 2036 (computed from the first US licence) | Marketed | Astellas | CLDN18 | 1 |
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 2036
In the product30 of these 44 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.