ZolpiMist, page-3

ENGLEWOOD, CO / ACCESSWIRE / March 6, 2019 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, today announced the Company's licensing agreement with SUDA Pharmaceuticals Ltd (ASX: SUD) to distribute ZolpiMist^™ (zolpidem tartrate oral spray) outside the United States and Canada. ZolpiMist is a rapidly acting oral spray sleep aid and is the only FDA-approved oral spray formulation of zolpidem tartrate. Zolpidem tartrate tablets are marketed in the U.S. under the brand name Ambien^®.
SUDA Pharmaceuticals is a drug delivery company focused on oro-mucosal administration and is headquartered in Perth, Western Australia. SUDA has been granted the exclusive license to market and distribute ZolpiMist in major markets outside the United States and Canada. Aytu has assumed this perpetual, exclusive global licensing agreement with SUDA from Magna Pharmaceuticals, the former NDA holder of ZolpiMist.
The Aytu-SUDA licensing agreement calls for SUDA to lead commercial development and sublicensing efforts for ZolpiMist in major territories outside the United States and Canada, including Europe, Asia, and Latin America. The global sleep aid market is currently estimated at almost $50 billion in annual revenue, and annual revenue is estimated to reach nearly $80 billion in 2022.