In a 135-page opinion issued Thursday, but made public for the first time Friday in redacted form, Judge Sweet granted the New York Attorney General’s motion to enjoin drug maker Activis from dropping a twice-a-day Alzheimer’s drug called Namenda IR, whose patent protection is about to expire, in favor of a once-a-day version called Namenda XR. The switch was allegedly motivated to prevent triggering state laws requiring pharmacists to substitute generics that are “AB-rated” to the brand name drug — i.e., have the same active ingredient, “form, dosage, strength, and safety and efficacy profile.”  These laws can cause a sharp decline in revenue when a patent expires (referred to as the “patent cliff”). As Judge Sweet explained, companies may try to avoid the “patent cliff” through a practice called “product hopping”:
Continue Reading Judge Sweet Blocks Activis From “Product Hopping” Alzheimer’s Drug To Avoid Triggering Laws Requiring Substitution of Generics