FDAnews Drug Daily Bulletin

Perrigo secured FDA approval of a generic version of Pepcid Complete, the chewable formulation of the OTC Pepcid heartburn franchise. The company will wait until the third quarter to launch the drug with 180-day exclusivity because patent litigation is pending appeal.

Perrigo is the only firm with an approved abbreviated new drug application for Pepcid Complete (famotidine/calcium carbonate/magnesium hydroxide), which has annual sales of approximately $95 million.

The FDA’s approval of the chewable formulation follows a ruling by the U.S. District Court for the Southern District of New York that the patent covering Pepcid Complete was not valid. Johnson & Johnson (J&J) and Merck market the brand drug.

Perrigo said J&J and Merck appealed that ruling and an at-risk launch is not planned for the immediate future. The generic will be marketed under private-label store brands when it is launched.