US protection

US protection ending in 2028: Chemically induced

As of the edition of 20 October 2026, 14 drugs have US protection that ends in 2028 in chemically induced; 14 of them have at least one company on route B because of it.

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

14 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Adalimumab Ends 2028 (orphan exclusivity)Marketed AbbVie TNF 4
Apremilast Ends 2028 (patent)Marketed Amgen PDE4A, PDE4B, PDE4C 4
Brexpiprazole Ends 2028 (patent)Marketed Otsuka DRD2, HTR1A, HTR2A 2
Buprenorphine Ends 2028 (exclusivity)Marketed Indivior OPRK1, OPRM1 9
Daratumumab Ends 2028 (orphan exclusivity)Marketed Johnson & Johnson CD38 1
Empagliflozin Ends 2028 (patent)Marketed Boehringer Ingelheim SLC5A2 1
Esketamine Ends 2028 (exclusivity)Marketed Johnson & Johnson GRIN1, GRIN2A, GRIN2B 5
Gepirone Ends 2028 (exclusivity)Marketed Fabre Kramer Pharmaceuticals HTR1A 1
Oxybate Ends 2028 (exclusivity)Marketed GABBR1, GABBR2 2
Rilonacept Ends 2028 (orphan exclusivity)Marketed Kiniksa Pharmaceuticals IL1B 1
Rituximab Ends 2028 (orphan exclusivity)Marketed Roche MS4A1 1
Safinamide Ends 2028 (patent)Marketed Supernus Pharmaceuticals MAOB 1
Tacrolimus anhydrous Ends 2028 (exclusivity)Marketed Astellas FKBP1A 3
Tofacitinib Ends 2028 (exclusivity)Marketed Pfizer JAK1, JAK2, JAK3 2

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 2028 in chemically induced

In the product

14 of these 14 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.