Depomed ($DEPO) chalked up a couple of much-needed wins in its ongoing fight to protect its shingles pain drug Gralise from generic competition. Two drugmakers--Watson Laboratories and Par Pharmaceutical--backed away from their proposed Gralise copies, leaving Depomed with three generic dragons still to fight.
The company has been in a bit of a fix. It claims that at least 6 patents protect Gralise at least through 2016, if not 2021. But Gralise is a new, once-daily version of gabapentin, an off-patent drug that Pfizer ($PFE) still sells under its own brand name, Neurontin. Depomed won the FDA's blessing for Gralise under the agency's Orphan Drug program. But FDA hasn't granted Gralise the 7 years of market exclusivity that typically goes along with Orphan Drug designation.
So Gralise's market position isn't exactly a stronghold. Generics makers went after the new brand almost as soon as it won FDA approval--Depomed has been fighting patent challengers ever since. Dispensing with two more of them must be a relief.
Meanwhile, Depomed sued the FDA in September, saying it's entitled to that Orphan Drug exclusivity. The FDA, for its part, says Depomed has to earn that exclusivity by proving that Gralise is clinically superior to the old gabapentin formula.
- read the Depomed release
- see the San Francisco Business Times story