March 26th a Big Day for Tadalafil – 15 ANDAs Stand Up to Be Counted

The 15 approvals for the generic of Cialis come on the day of the expirations of the 180-day exclusivity enjoyed by the first-to-file applicants.  Assuring that the ANDAs gain approval on the first legally possible date that they can be approved means that the price will go down and, when 15 ANDAs receive approval, the price decrease should be substantial.

The process and logistics for final ANDA approval of a large number of ANDAs on a single day, with the number of checks and final reviews that must be made entails a significant amount of OGD resources.  While OGD has said that there will be down months as well as up months, with these 15 ANDAs for Tadalafil – this will be (by any interpretation) an up month.  To see the 15 ANDAs approved, click here.