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.
About Synthon
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.
For further information on Synthon Pharmaceuticals, Inc please see www.synthon-usa.com.
Adcirca® is a trademark of Eli Lilly and Company