US protection

US protection ending in 2029: Injuries

As of the edition of 20 October 2026, 11 drugs have US protection that ends in 2029 in injuries; 7 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
Atezolizumab Ends 2029 (orphan exclusivity)Marketed Roche CD274 1
Budesonide Ends 2029 (exclusivity)Marketed NR3C1 5
Dapagliflozin Ends 2029 (patent)Marketed AstraZeneca SLC5A2 2
Edaravone Ends 2029 (exclusivity)Marketed Shionogi 0
Flurpiridaz Ends 2029 (exclusivity)Marketed GE Healthcare 0
Lapatinib Ends 2029 (patent)Marketed Novartis EGFR 2
Nitric oxide Ends 2029 (patent)Marketed Byk-Mallinckrodt CIL GUCY1B1, GUCY1B2 4
Oxymorphone Ends 2029 (patent)Marketed Endo OPRD1, OPRK1, OPRM1 0
Phenobarbital Ends 2029 (exclusivity)Marketed SUN Pharmaceutical Industries 0
Ruxolitinib Ends 2029 (exclusivity)Marketed JAK1, JAK2 4
Trazodone Ends 2029 (patent)Marketed Pragma Pharmaceuticals HTR2A, HTR2C 1

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 injuries

In the product

7 of these 11 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.