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Elite Pharmaceuticals Announces Filing of Abbreviated New Drug Application with the U.S. Food and Drug Administration for Generic Anticoagulant Product, M&A Valuation is up

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Jun 1, 2026 · 12:07

|**Elite Pharmaceuticals Announces Filing of Abbreviated New Drug Application with the U.S. Food and Drug Administration for Generic Anticoagulant Product**|
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|Northvale, New Jersey--(Newsfile Corp. - June 1, 2026) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today announced that it has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for a generic drug product in the class of medications called anticoagulants. IQVIA reported branded product sales for the twelve months ending March 2026 of $26 billion. There is no generic product on the market, and the brand has unexpired patents and exclusivity listed in the FDA's Approved Drug Products with Therapeutic Equivalence (Orange Book). FDA approval and commercialization of a generic product depend on successful filing, FDA approval and addressing the unexpired patents and exclusivities.|