Generic drugmaker aims at Gilead’s Hepsera
A generic drug maker plans to make a version of the Gilead Sciences Inc. chronic hepatitis B drug Hepsera.
Privately held Sigmapharm Laboratories LLC of Bensalem, Pa., submitted an abbreviated new drug application, or ANDA, to the Food and Drug Administration for permission to make and market generic Hepsera, according to Foster City-based Gilead (NASDAQ: GILD)
Sigmapharm claims that two patents for Hepsera, or adefovir dipivoxil, are invalid, unenforceable or will not be infringed by its generic.
Gilead, which said it is reviewing Sigmapharm’s notice, has 45 days to respond to the application, possibly by filing a patent infringement suit against Sigmapharm. That would suspend the FDA approval process for as long as 30 months.
If Gilead does not respond, Sigmapharm would be able to continue through the FDA drug approval process.
Once-a-day Hepsera tablets, approved by the FDA in September 2002 and European regulators in March 2003, registered sales of $271 payday loan lenders.6 million last year, down 20 percent from 2008. Six-month sales this year of $109.5 million were off nearly 22 percent from the same period last year.
Hepsera costs patients $813 per month.
As the first to challenge Gilead’s patent, Sigmapharm’s drug, if approved, would receive a 180-day monopoly on its lower-cost generic version. That generic monopoly period can translate into big bucks, since the price can be significantly less than that charged for a brand-name drug but not as low as when other generic companies jump in.
Sigmapharm, whose executive team includes former Impax Laboratories sales leader Mitchell Goldberg, has three approved drugs marketed by Rising Pharmaceuticals Inc.
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