Generic Combination Antiplatelet Agent Launches in US

Teva has launched a generic version of aspirin and extended-release dipyridamole (Aggrenox) capsules in the United States.

This combination antiplatelet agent is indicated to reduce the risk of stroke in patients who have previously experienced a transient ischemic attack or stroke due to thrombosis.

One American dies from a stroke every 4 minutes, on average. Of the 800,000 Americans who experience a stroke annually, 25% had a previous stroke.

“Teva recognizes the devastating impact of a stroke and is pleased to launch generic aspirin and extended-release dipyridamole capsules as a treatment option for at-risk stroke patients,” stated Brendan O’Grady, president and CEO of North America Generic Medicines for Teva.

This product is contraindicated in patients with known hypersensitivity to aspirin or dipyridamole, those with known allergy to nonsteroidal anti-inflammatory drugs, and patients with asthma, rhinitis, and nasal polyps.

The most frequently reported adverse reactions to aspirin and extended-release dipyridamole capsules in a placebo-controlled clinical study were headache, dyspepsia, abdominal pain, nausea, and diarrhea.

As of April 2015, Aggrenox had annual sales of about $457 million in the United States, according to IMS data.