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Four major patents for Acorda Therapeutics’ successful MS treatment Ampyra were invalidated by a federal judge nearly a decade before they were set to expire — not a month after they were upheld by the PTO. Read More
The Maryland state legislature approved a bill to ban excessive price increases for generics and off-patent drugs, sending it to the state’s governor for final approval. Read More
For the development of generic versions of naloxone, an emergency nasal spray treatment for opioid overdoses, the FDA said it will allow sponsors to demonstrate bioequivalence using solely in vitro performance tests — as long as the generic is qualitatively the same as the reference product. Read More
In a lawsuit filed Monday, Sanofi says Mylan’s anticompetitive business practices blocked its EpiPen competitor, the Auvi-Q, from gaining a foothold in the epinephrine auto-injector market, resulting in hundreds of millions in lost sales. Read More
A California prosecutor is suing Boehringer Ingelheim and a Teva subsidiary, saying their $120 million agreement to push back the release of a generic Aggrenox blood thinner illegally delayed market competition for over seven years. Read More
Jazz Pharmaceuticals settled a seven-year long patent infringement suit over generic copies of its Xyrem solution for narcolepsy, just weeks before the case was scheduled to go to trial. Read More
A federal judge has ruled that a class-action antitrust lawsuit against several generics manufacturers, alleging price-fixing of propranolol capsules and tablets, can proceed in court. Read More
A federal appeals court upheld that a Novartis patent for its multibillion-dollar MS drug Gilenya is invalid, opening the door for generics as early as 2019. Read More
In a Senate committee markup scheduled for May 10, lawmakers will consider the next generation of the FDA’s generic user fee program, using dollar amounts negotiated over the last two years with industry. Read More