Novartis, Others Staring Down Antitrust Lawsuit Over Alleged Exforge Market Fixing

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A proposed antitrust class action out of New York federal court seeks treble damages stemming from an alleged competition-suppressing scheme by which defendants Novartis, Endo Pharmaceuticals, and Par Pharmaceutical have monopolized the market for Exforge, an FDA-approved hypertension treatment drug. The plaintiff company seeks “overcharge damages” over what it claims is an unlawful agreement between Novartis and Par to not compete in the market for Exforge and corresponding AB-rated generic drug products.

Novartis made more than $400 million annually in the United States from sales of Exforge before similar generics entered the market, the lawsuit says. Around October and November 2007, Par and non-party Synthon Pharmaceuticals filed Abbreviated New Drug Applications (ANDA) with the FDA seeking approval for generic versions of Exforge, the case explains, and a deal was reached between the companies in late 2011 that saw Par agreeing to purchase Sython’s ANDA.

An obstacle Par and Sython faced, the suit notes, was that Novartis owned three patents for Exforge at the time, for which the case says the companies eventually settled on a workaround:

“On information and belief, in their ANDAs, Par and Synthon addressed the three Novartis patents by indicating that: (1) they would not seek final FDA approval until the September 21, 2012 expiration of exclusivities associated with the ‘578 Patent, however, (2) they would seek final FDA approval to market, and intended to launch, their ANDA products prior to the expiration of the follow-on patents—the ‘197 and ‘728 Patents—which they claimed were invalid and/or would not be infringed by their proposed generic equivalents.”

According to the complaint, upon learning of Par’s acquisition of Sython’s ANDA and the potential challenges their arrangement presented to Novartis’s patents for Exforge, Novartis reached a deal with Par in 2011 agreeing “not to compete in the market for fixed combinations of amlodipine and valsartan” until September 30, 2014. The arrangement, the suit goes on, essentially gave Novartis “the entire Exforge market” unchallenged for years beyond the 2012 expiration of its certain relevant patents. 

“Upon information and belief, the Agreement centered on Novartis’s agreement to refrain from launching an AG version of Exforge for the first six months after Par’s delayed launch, thereby depriving the market of an additional competitor and lower prices,” the lawsuit alleges.

Despite receiving tentative FDA approval for its ANDA in March 2010, Par did not release its generic version of Exforge until September 2014, according to the suit. Curiously, for a period of six months thereafter, the case says, “the only generic available for [the plaintiff] and other direct purchasers was Par’s product.”

Had the defendants’ alleged scheme not been in place, at least one generic version of Exforge would’ve been available as early as September 2012, per the complaint, and proposed class members wouldn't have paid supra-competitive prices for the treatment during the following years.