What's Going On With RedHill Biopharma?
RedHill Biopharma (RDHL) today announced that it has entered into a settlement and license agreement with Aurobindo Pharma USA, Inc. essentially ending their patent litigation in the U.S. in response to Aurobindo's Abbreviated New Drug Application seeking approval by the U.S. Food and Drug Administration to market a generic version of Movantik® (naloxegol).
Shares of the company were trading higher 0.8421% to $4.79 a share on Thursday.
What Does This Mean For RedHill Biopharma?
It seems RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, with the exception of Europe and Canada. The settlement agreement means Aurobindo is not permitted to sell a generic version of Movantik in the U.S. until April 1, 2031 or earlier under certain circumstances.
All parties involved have also agreed to file a stipulation and order of dismissal with the U.S. District Court for the District of Delaware, thus concluding this litigation with respect to Aurobindo. The settlement was made in accordance with The Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act).
RedHill Biopharma Ltd., a specialty biopharmaceutical company, primarily focused on gastrointestinal and infectious diseases.
RDHL has a Fundamental Rank of 93. Find out what this means to you and get the rest of the rankings on RDHL!
Redhill Biopharma Ltd is a specialty biopharmaceutical company focused on gastrointestinal diseases. The company promotes gastrointestinal drugs, including Movantik for opioid-induced constipation in adults, Talicia for the treatment of Helicobacter pylori infection in adults, and Aemcolo for the treatment of travelers' diarrhea in adults. Its key clinical late-stage development programs include RHB-104 for Crohn's disease; RHB-204, for pulmonary nontuberculous mycobacteria infections; RHB-102 (Bekinda) with positive results from a first Phase 3 study for acute gastroenteritis and gastritis; Opaganib (Yeliva); RHB-106, an encapsulated bowel preparation and RHB-107, a Phase 2-stage serine protease inhibitor targeting cancer and inflammatory gastrointestinal diseases.
