Lannett announced it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg, the therapeutic equivalent to the reference listed drug, Aggrenox® Capsules, 25 mg/200 mg, of Boehringer Ingelheim Pharmaceuticals. Total U.S. sales of Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg, was approximately $174.6 million for the 12 months ended January 2019, according to IQVIA, although actual generic market values are expected to be lower.
"The commercial opportunity for our Aspirin and Extended-Release Dipyridamole Capsules product, which was developed internally, is meaningful," said Tim Crew, chief executive officer of Lannett. "The launch of this product is expected in the near term and is part of an ongoing and concerted effort to add new products to our offering. Since January of last year, we have commenced marketing nearly 20 products and we expect to maintain that launch pace moving forward. We continue to make substantial investments in product development and expand in-licensing opportunities to replenish our pipeline, which is sizable relative to our portfolio, and add revenues and improve profitability."
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