TWi Pharmaceuticals, Inc. today announced that it launched its generic version of Par Pharmaceutical's MEGACE ES® (megestrol acetate oral suspension) 625mg/5ml after the United States District Court for the District of Maryland reinstated its finding that United States Patent No. 7,101,576 (the '576 Patent) is invalid.
"We are very pleased to see the court reinstating its original ruling in favor of TWi and to launch the generic Megace ES today," said Tina Guilder, President and CEO of TWi. "This favorable decision not only validates TWi's capability in successful patent challenges but more importantly, allows TWi to fulfill its commitment to bring high-quality affordable pharmaceutical products to the patients."
TWi's Abbreviated New Drug Application ("ANDA") for its generic version of MEGACE ES® was approved by US FDA on August 27, 2014. As the first applicant to file an ANDA for MEGACE ES®, TWi has been deemed eligible for 180-day generic market exclusivity by US FDA.
MEGACE ES® is indicated for the treatment of appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients. According to IMS Health, a market research firm, the total annual sales of Megace ES® in the U.S. were approximately US$44 million for the year ended in May 2015.
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