US protection

US protection ending in 2037

As of the edition of 20 October 2026, 29 drugs have US protection that ends in 2037; 17 of them have at least one company on route B because of it.

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

29 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Baloxavir marboxil Ends 2037 (patent)Marketed Roche 0
Berahyaluronidase alfa Ends 2037 (computed from the first US licence)Marketed Merck & Co. 0
Clesrovimab Ends 2037 (computed from the first US licence)Marketed Merck & Co. 0
Datopotamab deruxtecan Ends 2037 (computed from the first US licence)Marketed Daiichi Sankyo TACSTD2, TOP1 2
Depemokimab Ends 2037 (computed from the first US licence)Marketed GSK IL5 0
Ensartinib Ends 2037 (patent)Marketed Xcovery ALK 1
Entrectinib Ends 2037 (patent)Marketed Roche ALK, NTRK1, NTRK2 4
Eravacycline Ends 2037 (patent)Marketed L 0
Indigotindisulfonate Ends 2037 (patent)Marketed Provepharm 0
Lasmiditan Ends 2037 (patent)Marketed Eli Lilly HTR1F 1
Lerodalcibep Ends 2037 (computed from the first US licence)Marketed LIB Therapeutics PCSK9 1
Linvoseltamab Ends 2037 (computed from the first US licence)Marketed Regeneron CD3D, CD3E, CD3G 1
Narsoplimab Ends 2037 (computed from the first US licence)Marketed Omeros MASP2 1
Navepegritide Ends 2037 (patent)Marketed Ascendis Pharma A/S NPR2 1
Nipocalimab Ends 2037 (computed from the first US licence)Marketed Johnson & Johnson FCGRT 1
Orforglipron Ends 2037 (patent)Marketed Eli Lilly GLP1R 0
Palopegteriparatide Ends 2037 (patent)Marketed Ascendis Pharma A/S PTH1R 3
Penpulimab Ends 2037 (computed from the first US licence)Marketed Akeso PDCD1 1
Piflufolastat Ends 2037 (patent)Marketed Lantheus Biosciences FOLH1 2
Prademagene zamikeracel Ends 2037 (computed from the first US licence)Marketed Abeona Therapeutics 0
Revakinagene taroretcel Ends 2037 (reference-product exclusivity)Marketed Neurotech Pharmaceuticals 0
Revumenib Ends 2037 (patent)Marketed Syndax Pharmaceuticals KMT2A, MEN1 1
Sars-cov-2 virus spike protein Ends 2037 (computed from the first US licence)Marketed Sanofi 0
Sebetralstat Ends 2037 (patent)Marketed Chiesi Farmaceutici KLKB1 1
Sibeprenlimab Ends 2037 (computed from the first US licence)Marketed Otsuka TNFSF13 1
Telisotuzumab vedotin Ends 2037 (computed from the first US licence)Marketed AbbVie MET, TUBB, TUBB1 10
Zanubrutinib Ends 2037 (patent)Marketed BeiGene BTK 1
Zopapogene imadenovec Ends 2037 (computed from the first US licence)Marketed Precigen 0
Zuranolone Ends 2037 (patent)Marketed Biogen 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 2037

In the product

17 of these 29 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.