Medicis' Skin Drug Gets Generic Threat From Actavis Mid Atlantic
Generic manufacturers are circling over Medicis Pharmaceutical Corp.’s new skin cancer drug.
In an 8-K filing today, Medicis notified the U.S. Securities and Exchange Commission that a generic version of Zyclara may be on the horizon. If Medicis’ history with other generic drug makers is any indication, this could be the first of many patent infringement lawsuits that Medicis will file in an effort to protect its intellectual property. However, company officials did not say whether they would file a lawsuit or not.
On Aug. 8, the Scottsdale-based drug manufacturer received notice from Switzerland-based Actavis Mid Atlantic LLC that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration. This ANDA notifies the FDA that Actavis wants to create a generic version of Zyclara, which is used to treat certain types of actinic keratoses, which are flat, scaly growths on the skin caused by too much sun exposure.
When a manufacturer wants to create a generic version of a drug on the market, it is required to file an ANDA with the FDA and notify the original drug maker that it intends to make a generic version of its product.
Then the fun begins.
As part of its ANDA filed with the FDA, Actavis alleges that Medicis’ patent for Zyclara is invalid and unenforceable, according to today’s 8-K filing. That particular patent expires in 2029, according to the 8-K.