Mylan Pharmaceutical's Xulane is the first generic contraceptive transdermal patch to hit the market, marking another milestone for the delivery technology.
Last week, generics makers asked the Supreme Court to let them launch their copies of Teva's Copaxone while it hears the Israeli company's appeal over the drug's patents. Now, they'll likely get that chance. Chief Justice John Roberts rejected Teva's bid to block competition until the court clash wraps, meaning generics could hit as soon as next month.
Teva wants generics makers to hold off on launching their copies of multiple sclerosis drug Copaxone until the Supreme Court hears its appeal in a patent fight over the drug. And unsurprisingly, those generics companies are not that into the idea.
On Monday, Teva asked Supreme Court Chief Justice John Roberts to consider a plea to block generic competition to Copaxone until SCOTUS has weighed its appeal. And now, he wants to know what generics makers think about it.
Just four months after closing its $1.75 billion acquisition of Agila Specialities, generic drug maker Mylan is eyeing another takeover candidate--Sweden's Meda AB. Pennsylvania-based Mylan is talking with advisers about a takeover bid that could be made at a "significant premium" to Meda's $4.5 billion market value, according to sources quoted by the Financial Times.
The Supreme Court has agreed to hear an appeal of a lower court's decision to invalidate Teva's Copaxone patent, which if restored will shield the drug until September 2015. The decision may, in the least, leave competitors wary of proceeding with generics, giving Teva more time to convert patients to a new, long-acting version of the treatment.
The market may do what regulators around the world have been unable to achieve so far: It may make quality and consistent supply the focus for generics buyers over price.
One of Pfizer's top-selling products is suddenly vulnerable to generic competition 18 months earlier than expected. A U.S. court nixed a key Celebrex patent, putting the pain drug up for a sales fight in May. And generics makers Mylan and Actavis are promising to launch their versions as soon as Pfizer's monopoly expires.
Generic drug maker Mylan turned itself into one of the largest makers of sterile injectable drugs last year with its $1.75 billion acquisition of Agila Specialties. Today the drugmaker pointed to one reason to take on all of that production capacity. Its earnings got a big boost from injectable products, in part because of drug shortages.
Labeling problems can lead to a recall, particularly when a drug is missing its expiration date labels--or some of the paper label pieces end up in vials. That is the scenario Mylan faces in recalling products made by Agila Specialties, the injectable drug company it bought last year for $1.7 billion.