Synthon First Generic Filer for Tadalafil 20 mg
RTP, North Carolina, 22 March 2010.
Synthon Pharmaceuticals Inc. ("Synthon") is confirming today that it has been sued by Eli Lilly and Company ("Lilly") and Icos Corporation ("Icos") in connection with the filing of Synthon's Abbreviated New Drug Application (ANDA) for Tadalafil 20 mg. Synthon's Tadalafil 20 mg Tablets product is a generic and bioequivalent version of Lilly's and United Therapeutics' Adcirca® tablets which is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability.
Synthon believes that it is the 'Single First Filer' of an ANDA with a Paragraph IV certification for the Adcirca® (Tadalafil) tablets, 20 mg. As a result, Synthon expects to be eligible for 180 days of Hatch-Waxman exclusivity upon the first commercial marketing of their generic drug product.
Synthon's Tadalafil ANDA submission is one of several recently submitted first to file ANDA's of the company and confirms Synthon's track record in filing and launching generic drugs at the earliest possibility. This regulatory filing is another example of Synthon's objective to provide patients with high quality, affordable medicines.
Synthon is a privately owned specialty pharma company. With facilities in nine different countries, the company is dedicated to research, development, production, licensing and marketing of high quality alternatives to innovative medicines.