Gilead Sciences’ lawsuit against Lupin is based on an abbreviated new drug application filed by Lupin, seeking approval to manufacture and market a generic version of Ranexa before the expiration of Gilead’s Ranexa patents.
Ranexa is an anti-anginal medication. It works by improving blood flow to help the heart work more efficiently.
Ranexa is used to treat chronic angina (chronic chest pain). It may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.
Gilead Sciences said that Ranexa is currently protected by 10 patents, which are listed in the approved drug products list of FDA and all 10 patents would need to be invalidated, expire or not be infringed before a generic version of Ranexa could be marketed.