Polymorphs of Dex-Lansoprazole
New Crystalline Forms of Dex-Lansoprazole Discovered
PolyCrystalLine s.r.l. and Segrub Pharmaceuticals have developed a generic equivalent to Kapidex (dexlansoprazole). This DEP002 product contains a new and stable crystal of dexlansoprazole which circumvents Takeda’s intellectual property.
Kapidex is a proton pump inhibitor that obtained FDA approval in 2009 by Takeda Pharmaceuticals for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE.
Takeda’s patent protection on Kapidex centers on distinct crystalline forms identified by Takeda. The four patents listed in the Orange Book claim and disclose specific crystalline forms. The dexlansoprazole API is old and no patent protection exists for the molecule in general.
The DEP002 product contains a new stable and pharmaceutically acceptable crystal of dexlansoprazole.
This new crystal circumvents all of Takeda’s patent protection for Kapidex.
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