For Forest, one Bystolic test down, six to go
Forest Labs may have settled a patent challenge from generics maker Hetero, but the drugmaker has yet to come to terms with six others seeking to market BP med Bystolic before its patent runs out.
Forest and Indian generics firm Hetero announced they reached a deal under which Hetero wouldn't launch its Bystolic copy until three months prior to the expiration of the med's ‘040 patent -- which would be in late 2021 -- or when Hetero receives FDA sign-off of its ANDA, whichever comes later. The deal follows submission by the parties of a joint stipulation and order to dismiss their patent case.
The settlement gets Forest closer to locking up exclusivity on Bystolic through 2016, say analysts. “We view clarity on this critical issue as a favorable first step toward resolving FRX's greatest uncertainty,” wrote Leerink Swann's Seamus Fernandez wrote in an investor note.
In practice, though, the settlement has little impact on what Fernandez calls Forest's “Bystolic overhang.” Six other players including Watson, have filed ANDAs, meaning patent infringement litigation with those filers remains in the courts. Forest must settle with all parties to fully resolve the Bystolic challenge.
That's not such a long shot. As Leerink points out, Forest successfully executed a multi-party settlement on Alzheimer's drug Namenda with 11 generic challengers, who had sought to market copies of the drug before its scheduled loss of exclusivity in 2015.
Forest is hurting from the 2012 patent expiration of depression med Lexapro, but COPD drug Tudorza (aclidinium) and IBS drug Linzess (linaclotide) were both approved this year, and the company's portfolio includes other potential new drugs including antipsychotic cariprazine and antidepressant levomilnacipran.