A U.S. appeals court has officially spoiled Actavis' plot to force patients over to a new, patent-protected version of Namenda to preserve the med's revenues when generics hit. So if other drugmakers are considering the tactic, they'd better think twice.
Actavis said last month that it stood to lose $200 million in sales if an appeals court didn't let it force patients over to a new, patent-protected version of Alzheimer's treatment Namenda before generics hit. But if the court does allow the so-called hard switch? The federal government stands to lose much, much more.
Generics makers have been champing at the bit to get a copy out of Teva's Copaxone, the best-selling multiple sclerosis med that generated $4.2 billion in revenue last year. But according to Momenta CEO Craig Wheeler, his company's version--a joint effort with partner Sandoz, Novartis' generics unit--may be the only knockoff around for a while.
Just hours after Bristol-Myers Squibb beat Wall Street expectations with earnings that got a goose from antipsychotic Abilify, the FDA opened the floodgates to generics of the blockbuster.
It's been a long battle since a court upturned Teva's Copaxone patent in July 2013, but a Supreme Court fight, several petitions and a regulatory journey later, Copaxone generics are here.
Otsuka has already sued the FDA to block generic versions of the blockbuster antipsychotic Abilify, claiming that its orphan drug exclusivity on one indication should preclude copycat meds entirely.
Hefty increases in drug spending have lawmakers all riled up, and a new voice is joining the growing chorus of discontent. The Department of Health and Human Services is weighing in on the issue, planning to investigate the cause of soaring generic drug prices amid congressional pushback.
Generics player Natco Pharma has already made plenty of waves in the Indian pharma market with cheaper versions of blockbuster meds, playing by a patent challenge strategy that's ignited the ire of more than one Big Pharma company. Now, as it awaits U.S. approval for its knockoff of Teva's Copaxone, it's eyeing up other products to copy, too.
Since Mylan went public on Wednesday with a $205-per-share buyout offer for Ireland's Perrigo, analysts have been weighing the pros and cons of a tie-up between the two generics makers. But there's one thing at least a few of them agree on: The $29 billion bid has to be a response to other M&A action going on behind the scenes.
In a year when several of his peers won big payoffs for one extraordinary reason or another, Amgen CEO Robert Bradway earned just about as much as he had the previous year, give or take a few hundred thousand. Small comfort--though some comfort, perhaps--to the thousands of employees facing job cuts as Amgen prepares for biosimilar competition to its top-selling meds.