US protection

US protection ending in 2027: Lungs and airways

As of the edition of 20 October 2026, 34 drugs have US protection that ends in 2027 in lungs and airways; 18 of them have at least one company on route B because of it.

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

34 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Anakinra Ends 2027 (orphan exclusivity)Marketed Swedish Orphan Biovitrum IL1R1 0
Artesunate Ends 2027 (exclusivity)Marketed Amivas 0
Bazedoxifene Ends 2027 (patent)Marketed Pfizer ESR1, ESR2 0
Bevacizumab Ends 2027 (orphan exclusivity)Marketed Roche VEGFA 2
Canakinumab Ends 2027 (orphan exclusivity)Marketed Novartis IL1B 1
Dinutuximab Ends 2027 (computed from the first US licence)Marketed United Therapeutics 0
Edoxaban Ends 2027 (patent)Marketed Daiichi Sankyo F10 1
Enzalutamide Ends 2027 (patent)Marketed Astellas AR 1
Ferric carboxymaltose Ends 2027 (patent)Marketed American Regent 0
Fluticasone furoate Ends 2027 (patent)Marketed GSK NR3C1 0
Insulin degludec Ends 2027 (computed from the first US licence)Marketed Novo Nordisk INSR 0
Ipilimumab Ends 2027 (orphan exclusivity)Marketed Bristol Myers Squibb CTLA4 1
Lenalidomide Ends 2027 (patent)Marketed Bristol Myers Squibb CRBN 0
Lonafarnib Ends 2027 (exclusivity)Marketed Sentynl Therapeutics FNTA, FNTB 3
Mepolizumab Ends 2027 (computed from the first US licence)Marketed GSK IL5 0
Mesalamine Ends 2027 (patent)Marketed Viatris PPARG, PTGS1, PTGS2 12
Methylene blue cation Ends 2027 (exclusivity)Marketed Provepharm GUCY1A1, GUCY1A2, GUCY1B1 1
Necitumumab Ends 2027 (computed from the first US licence)Marketed Eli Lilly EGFR 0
Nintedanib Ends 2027 (exclusivity)Marketed Boehringer Ingelheim FGFR1, FGFR2, FGFR3 9
Olive oil Ends 2027 (exclusivity)Marketed Baxter Healthcare 0
Olodaterol Ends 2027 (patent)Marketed Boehringer Ingelheim ADRB2 0
Pantoprazole Ends 2027 (exclusivity)Marketed Pfizer ATP4A 1
Regadenoson anhydrous Ends 2027 (patent)Marketed Astellas ADORA2A 2
Rifaximin Ends 2027 (patent)Marketed Bausch Health 0
Sacubitril Ends 2027 (patent)Marketed Novartis MME 1
Saxagliptin anhydrous Ends 2027 (exclusivity)Marketed AstraZeneca DPP4 2
Secukinumab Ends 2027 (computed from the first US licence)Marketed Novartis IL17A 1
Sorafenib Ends 2027 (patent)Marketed Bayer BRAF, FLT1, FLT3 1
Talimogene laherparepvec Ends 2027 (computed from the first US licence)Marketed Amgen 0
Tapentadol Ends 2027 (exclusivity)Marketed Collegium Pharmaceutical OPRM1, SLC6A2 4
Telavancin Ends 2027 (patent)Marketed Apotex 0
Umeclidinium Ends 2027 (patent)Marketed GSK CHRM3 0
Voclosporin Ends 2027 (patent)Marketed Aurinia Pharmaceuticals PPP3CA 2
Vorinostat Ends 2027 (patent)Marketed Merck & Co. HDAC1, HDAC2, HDAC3 4

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 2027 in lungs and airways

In the product

18 of these 34 drugs have at least one company on route B. Which companies, and their scores, are in the product.

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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.