US protection

US protection ending in 2029

As of the edition of 20 October 2026, 56 drugs have US protection that ends in 2029; 30 of them have at least one company on route B because of it.

Sources: FDA Orange Book and Purple Book, other approval registers.

56 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Abacavir Ends 2029 (patent)Marketed GSK 0
Afatinib Ends 2029 (patent)Marketed Boehringer Ingelheim EGFR 1
Amifampridine Ends 2029 (exclusivity)Marketed Angelini Pharma 0
Atazanavir Ends 2029 (patent)Marketed Bristol Myers Squibb 0
Atezolizumab Ends 2029 (orphan exclusivity)Marketed Roche CD274 1
Avelumab Ends 2029 (computed from the first US licence)Marketed Merck KGaA CD274 1
Azacitidine Ends 2029 (exclusivity)Marketed Bristol Myers Squibb DNMT1, DNMT3A 4
Bedaquiline Ends 2029 (patent)Marketed Johnson & Johnson 0
Bendamustine Ends 2029 (patent)Marketed Teva 0
Berdazimer sodium Ends 2029 (exclusivity)Marketed Lnhc 0
Brentuximab vedotin Ends 2029 (orphan exclusivity)Marketed Pfizer TNFRSF8, TUBB, TUBB1 10
Brodalumab Ends 2029 (computed from the first US licence)Marketed Bausch Health IL17RA 3
Budesonide Ends 2029 (exclusivity)Marketed NR3C1 5
Canagliflozin anhydrous Ends 2029 (patent)Marketed Johnson & Johnson SLC5A2 2
Cariprazine Ends 2029 (patent)Marketed AbbVie DRD2, DRD3 4
Crisaborole Ends 2029 (patent)Marketed Pfizer PDE4A, PDE4B, PDE4C 0
Crizotinib Ends 2029 (patent)Marketed Pfizer ALK, MET, ROS1 2
Dapagliflozin Ends 2029 (patent)Marketed AstraZeneca SLC5A2 2
Edaravone Ends 2029 (exclusivity)Marketed Shionogi 0
Eluxadoline Ends 2029 (patent)Marketed AbbVie OPRM1 1
Emicizumab Ends 2029 (computed from the first US licence)Marketed Roche F10, F9 2
Etonogestrel Ends 2029 (exclusivity)Marketed Organon PGR 1
Ferric derisomaltose Ends 2029 (patent)Marketed Pharmacosmos TF 2
Ferric pyrophosphate citrate Ends 2029 (patent)Marketed Rockwell Medical 0
Florbetaben Ends 2029 (patent)Marketed Lantheus Biosciences 0
Flurpiridaz Ends 2029 (exclusivity)Marketed GE Healthcare 0
Ganaxolone Ends 2029 (exclusivity)Marketed Immedica Pharma 0
Gemtuzumab ozogamicin Ends 2029 (computed from the first US licence)Marketed Pfizer CD33 0
Guselkumab Ends 2029 (computed from the first US licence)Marketed Johnson & Johnson IL23A 1
Infigratinib Ends 2029 (patent)Marketed Helsinn Healthcare FGFR1, FGFR2, FGFR3 4
Iomeprol Ends 2029 (exclusivity)Marketed Bracco Diagnostics 0
Ixazomib citrate Ends 2029 (patent)Marketed Takeda PSMB5 0
Landiolol Ends 2029 (exclusivity)Marketed Aop Health ADRB1 1
Lapatinib Ends 2029 (patent)Marketed Novartis EGFR 2
Latanoprostene bunod Ends 2029 (patent)Marketed Bausch Health PTGFR 1
Linaclotide Ends 2029 (exclusivity)Marketed AbbVie GUCY2C 3
Lomitapide Ends 2029 (exclusivity)Marketed Chiesi Farmaceutici MTTP 1
Lumateperone Ends 2029 (patent)Marketed Johnson & Johnson DRD2, HTR2A, SLC6A4 1
Lurbinectedin Ends 2029 (patent)Marketed Jazz Pharmaceuticals 0
Nitric oxide Ends 2029 (patent)Marketed Byk-Mallinckrodt CIL GUCY1B1, GUCY1B2 4
Nonacog beta pegol Ends 2029 (computed from the first US licence)Marketed Novo Nordisk 0
Ocrelizumab Ends 2029 (computed from the first US licence)Marketed Roche MS4A1 0
Oxymorphone Ends 2029 (patent)Marketed Endo OPRD1, OPRK1, OPRM1 0
Phenobarbital Ends 2029 (exclusivity)Marketed SUN Pharmaceutical Industries 0
Posaconazole Ends 2029 (exclusivity)Marketed Merck & Co. 0
Ruxolitinib Ends 2029 (exclusivity)Marketed JAK1, JAK2 4
Sarilumab Ends 2029 (computed from the first US licence)Marketed Sanofi IL6R 1
Simeprevir Ends 2029 (patent)Marketed Johnson & Johnson 0
Stiripentol Ends 2029 (exclusivity)Marketed Biocodex 0
Suvorexant Ends 2029 (patent)Marketed Merck & Co. HCRTR1, HCRTR2 2
Terlipressin Ends 2029 (exclusivity)Marketed Byk-Mallinckrodt CIL AVPR1A, AVPR1B, AVPR2 3
Tisagenlecleucel Ends 2029 (orphan exclusivity)Marketed Novartis CD19 1
Trazodone Ends 2029 (patent)Marketed Pragma Pharmaceuticals HTR2A, HTR2C 1
Varicella zoster virus envelope glycoprotein e Ends 2029 (computed from the first US licence)Marketed GSK 0
Vestronidase alfa Ends 2029 (computed from the first US licence)Marketed Ultragenyx Pharamceutical 0
Voretigene neparvovec Ends 2029 (computed from the first US licence)Marketed Roche 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 2029

In the product

30 of these 56 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.

US protection movers, once a month

The drugs that entered or left the two-year window in the latest edition. An email, not an account: it gives no access to the product.