King Pharmaceuticals, Inc., Aventis Pharma Deutschland GmbH (Sanofi-Aventis Deutschland GmbH) and Cobalt Pharmaceuticals, Inc. have entered into an agreement to dismiss the pending litigation relating to the enforcement of US Patent Nos. 5,061,722 (722 Patent) and 5,403,856 (856 Patent).
The parties agreed that, subject to certain conditions, within 38 days of signing the agreement, King, Aventis and Cobalt will submit a joint stipulation dismissing without prejudice the litigation before the US District Court for the District of Massachusetts.
Cobalt had sought to market generic versions of Altace (ramipril) before expiration of the '722 Patent and '856 Patent which relate to Altace by filing an Abbreviated New Drug Application.
Altace is marketed by Monarch Pharmaceuticals, Inc., a wholly owned subsidiary of King Pharmaceuticals, and Wyeth Pharmaceuticals in the United States and Puerto Rico pursuant to a co-promotion agreement.
Altace is a leading branded ACE inhibitor with multiple indications. Altace is indicated for the treatment of hypertension. Altace has also been shown to reduce the risk of death in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Based upon the results of the landmark HOPE trial, Altace is also indicated in patients 55 years or older at high risk of developing a major cardiovascular event either because of a history of coronary artery disease, stroke or peripheral vascular disease or because of diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of stroke, myocardial infarction, or death from cardiovascular causes. Altace can be used in addition to other needed treatments (such as antihypertensive, antiplatelet or lipid-lowering therapies).
Altace may cause swelling of the mouth, tongue, or throat, which could cause extremely serious risk and requires immediate medical care. Altace may lower blood sugar if taken for diabetes. A physician should be contacted if one experiences symptoms of low blood sugar such as sweating or shakiness. Common side effects include persistent dry cough, dizziness, and light-headedness due to low blood pressure. Altace should not be taken during pregnancy, as death or injury to an unborn child may result, or if serious side effects related to previous ACE inhibitors have occurred.