US protection

US protection ending in 2028: Injuries

As of the edition of 20 October 2026, 11 drugs have US protection that ends in 2028 in injuries; 8 of them have at least one company on route B because of it.

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

11 drugs

DrugUS protectionStatusHolderTargetRoute B rows
Apixaban Ends 2028 (exclusivity)Marketed Bristol Myers Squibb F10 2
Buprenorphine Ends 2028 (exclusivity)Marketed Indivior OPRK1, OPRM1 9
Empagliflozin Ends 2028 (patent)Marketed Boehringer Ingelheim SLC5A2 1
Esketamine Ends 2028 (exclusivity)Marketed Johnson & Johnson GRIN1, GRIN2A, GRIN2B 5
Ferric oxyhydroxide Ends 2028 (exclusivity)Marketed Vifor Fresenius Medical Care Renal Pharma 0
Ferumoxytol Ends 2028 (exclusivity)Marketed Azurity Pharmaceuticals 0
Olaparib Ends 2028 (patent)Marketed AstraZeneca PARP1, PARP2, PARP3 3
Oxybate Ends 2028 (exclusivity)Marketed GABBR1, GABBR2 2
Rituximab Ends 2028 (orphan exclusivity)Marketed Roche MS4A1 1
Tacrolimus anhydrous Ends 2028 (exclusivity)Marketed Astellas FKBP1A 3
Tocilizumab Ends 2028 (orphan exclusivity)Marketed Roche IL6R 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 2028 in injuries

In the product

8 of these 11 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.