Aspargo Laboratories, Inc. is seeking FDA approval to market in the United States a patented oral spray formulation of sildenafil citrate, the active ingredient in VIAGRA®, to treat erectile dysfunction. Aspargo’s proprietary drug formulation is protected by a granted U.S. patent that expires in 2036.
Aspargo has licensed the exclusive rights to commercialize Sildenafil Oral Spray in the United States from Farmalíder, S.A. (Madrid, Spain), a leader in the Spanish OTC and ibuprofen market.
Aspargo is seeking FDA approval for Sildenafil Oral Spray under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which provides that new dosage forms and new routes of administration for a previously approved drug qualify for an expedited form of regulatory approval.
Sildenafil Oral Spray, distributed and marketed in Spain on behalf of Farmalider by Laboratorios Rubio under the trade name, “Bandol”, is prescribed by Spanish physicians to treat erectile dysfunction as an alternative to VIAGRA® and Cialis® tablets. The technology was approved in Europe and commercially launched in Spain in late 2019 and is awaiting approval in 9 European countries and 8 Latin American countries. The product is going through the registration process in 40 jurisdictions worldwide.
Licensed by Farmalider to a leading Indian pharmaceutical company for sale in China; product registration process ongoing with planned commercial launch in 2021.
Licensed by Farmalider to a multinational generic pharmaceutical company for OTC sale in Israel; product registration process ongoing with planned commercial launch in 2021.