Endo Health Solutions lost its bid to thwart generic makers copying its high-powered painkiller Opana ER. The FDA decided Endo's tamper-resistant formula doesn't prevent drug abuse significantly better than earlier versions that weren't designed to deter abuse. That's a blow for Endo, which took in almost $300 million from the drug last year, or 10% of its total sales.
Purdue's original patent on the superpotent and often abused painkiller OyxContin expires tomorrow, and drugmakers are jockeying for a piece of its $2.8 billion market share. But the FDA is under increasing pressure to require generic drugmakers to make their formulations tamper-resistant.
Will the talk of an Endo Health Solutions buyout wind down now that it has hired a new CEO? Or will the company's choice, Rajiv De Silva, step in to shepherd it toward a sale?
If Endo Health Solutions ($ENDP) sells, you can credit--or blame--Fidelity Investments. That's according to Bloomberg sources, who say Fidelity is pressuring the board to make a deal. The time is right, Fidelity figures, because the company is searching for a new CEO anyway.
Endo Health Solutions' is feeling the generics pain this year as its key products face copycats and that may be enough to have sent it looking for a buyer.
The FDA is enmeshed in a process to find the right balance on how to approve and regulate addictive painkillers and a vote expected today is just one small piece of that puzzle-piecing exercise.
Endo Health Solutions' ($ENDO) attempt to outmaneuver generic competition by kicking dirt all over its own product has come up short.
Endo Health Solutions' ($ENDO) attempt to outmaneuver generic competition by kicking dirt all over its own product has come up short. A federal judge in Washington declined to force the FDA to declare the original formulation of Endo's pain drug Opana ER unsafe.
Endo Health Solutions ($ENDP) downgraded its earnings prospects for this year and next at the same time that it announced its CEO will retire by May.
In September, the generics subsidiary of Endo Health Solutions voluntarily recalled one lot of two pain drugs that it called "super potent" because both exceeded their prescribed weights. Now Endo has added 100 more lots to that removal.