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Dexlansoprazole DR capsule-60mg
Dexlansoprazole DR
Indication ­ ‒ ­Healing of all grades of erosive esophagitis (EE)
­ ‒ ­Maintaining healing of EE
­­‒ Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD)
Status First- to File (FTF), Par received final approval on April 2017.
Product Advantages ­ ‒ FTF, 180-day market exclusivity right in the USA.
­ ‒ settled with Takeda, and will launch in 2022.
Potential Market The market value of branded drug is about $1 billion per year. Par, a commercialization partner of Handa, is expected to occupy a certain market share.