Synthon receives tentative approval for tadalafil tablets

Apr 16 2012

Synthon has announced that its subsidiary Synthon Pharmaceuticals, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for tadalafil tablets, 20 mg on April 13, 2012. Synthon's product is a generic and bioequivalent version of Eli Lilly & Co and United Therapeutics’ Adcirca^® tablets, which are indicated for the treatment of pulmonary arterial hypertension to improve exercise ability.

Consistent with its business model, Synthon intends to commercialize the product by partnering with a leading generic company in the United States. Synthon is the ’Single First Filer’ and will benefit from 180 days of Hatch-Waxman exclusivity upon the first commercial marketing of their generic drug product. The period of 180 days exclusivity will be beneficial to the company, as well as to the U.S. healthcare system. The product will be launched upon final approval, which is anticipated in November, 2017.

Synthon’s CEO Rudy Mareel commented: “With this tentative approval and yet again a ‘Single First Filer’ status, our vertically integrated organization and expertise in R&D, IP, RA and other related areas prove to be key differentiators for Synthon.”

Sales for United Therapeutics of Adcirca^® were over USD 70 million in 2011** and expected sales by 2015 will be over USD 170 million***.

Synthon, with headquarters in Nijmegen, the Netherlands is an international fast-growing pharmaceutical company and a leader in the field of generic medicines. Synthon has been working in biotechnology since 2007 and is developing rapidly into a specialty pharmaceutical company, focusing on the therapeutic areas of auto-immune disease, multiple sclerosis and oncology. Synthon’s products are currently approved by regulatory agencies in over 80 countries worldwide and marketed through strategic partnerships and – in dedicated areas – through direct sales. Synthon employs about 1,400 staff at 11 sites worldwide, and in 2011 it recorded a turnover of EUR 260 million.

For more information, go to www.synthon.com. 

* Adcirca^® is a trademark of Eli Lilly and Company
** United Therapeutics Annual Financial Results 2011
*** According to analyst expectations from Leerink Swann