Synthon has been sued by Eli Lilly and Icos Corporation in connection with the filing of Synthon's 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.
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Apcalis represents a new class of medications known as PDE-5 inhibitors. These medications are used to treat erectile dysfunction (impotence). Apcalis can remain effective for up-to 48 hours which is why Apcalis is sometimes known as the 'weekender'
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