The Federal Trade Commission announced on Wednesday that Teva Pharmaceutical (TEVA), under pressure from the agency, has requested the removal of more than 200 patents improperly listed in the FDA’s official register of drugs, known as the “Orange Book.”
The move comes after the FTC renewed its calls over improper Orange Book patent listings in May, sending warning letters to companies including Novartis (NVS) and Teva (TEVA) regarding the appropriateness of more than 200 patents across 17 brand-name products.
Removal of TEVA’s patents from the register could pave the way for the market entry of generics referencing over 30 asthma, diabetes, and COPD drugs and epinephrine autoinjectors, the FTC said.
Drugmakers dodge rival products, including lower-cost generics, for 30 months after listing patents on the “Orange Book,” also known as “Approved Drug Products with Therapeutic Equivalence Evaluations.”
The FTC challenge followed a ruling from the U.S. Court of Appeals for the Federal Circuit, which, in a legal dispute between Teva (TEVA) and Amneal Pharmaceuticals (AMRX) determined that the Israeli drugmaker’s patents were improperly listed in the Orange Book.