Warner Chilcott, Mayne Pharma to Settle Over Claims on Generic Doryx Delay

Brand manufacturer Mayne Pharma and the U.S. marketer of Mayne’s acne drug Doryx, Warner Chilcott, have moved to settle class action claims with third party purchasers that allege the two companies inappropriately delayed generic competition on the product.

On July 11, plaintiffs in the class action suit filed a tentative settlement in the U.S. District Court for the Eastern District of Pennsylvania. Under the deal, Mayne and Warner would pay $8 million to three indirect purchasers, (1) the health and welfare funds of the International Brotherhood of Electrical Workers Local 38, (2) the International Union of Operating Engineers Local 132, and (3) the Laborers Health and Welfare Trust Fund for Northern California.

The proposed settlement, which must be approved by the district judge, is part of a broader, ongoing class action lawsuit headed by generics maker Mylan.

The lawsuit accuses Mayne and Warner of making multiple small changes to Doryx (doxycycline hyclate) over the course of several years, such as reworking the product’s scoring and switching from capsule to tablet form. In making these changes, the drugmakers would then withdraw the older versions of the drug to force would-be generics to go back to the drawing board to produce an AB-rated alternative, the suit says.

Mylan says the strategy hurt the company’s bottom-line. The indirect purchasers claim their health plans were forced to pay for Doryx at supracompetitive prices when they would have spent much less on generic versions.

Actavis acquired Warner Chilcott in October 2013. Doryx generated $173 million in U.S. sales in 2011. Generic versions of Doryx have since hit the market. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.