FDA Approval for Generic Version of Best-Selling Drug

After coming on the market in 1996, Lipitor quickly became the best-selling pharmaceutical in the country and in the world. To date, the cholesterol-lowering drug has generated more than $125 billion in sales. The market for a generic version of this blockbuster drug was set to open in 2011, with the first filer to the Food and Drug Administration (FDA) entitled to 180 days as the only generic on the market—a tremendous competitive advantage. Zuckerman Spaeder LLP’s Food and Drug Practice assisted client Ranbaxy Laboratories with its FDA Abbreviated New Drug Application (ANDA) and with navigating numerous other regulatory hurdles.

Ranbaxy is a long-standing Zuckerman Spaeder client, and we routinely advise the company on issues involving the Hatch-Waxman Act, FDA approval, and 180-day exclusivity. Partner Kate C. Beardsley has helped Ranbaxy work with the FDA to achieve approval of a number of generic pharmaceutical products, including its generic version of Lipitor. While Ms. Beardsley was shepherding Ranbaxy’s ANDA for its generic version of Lipitor through the FDA regulatory process, she was simultaneously negotiating a consent decree to settle FDA concerns that presented potential obstacles to approval. The consent decree strengthened Ranbaxy’s data integrity policies and its manufacturing practices, paving the way for the company to bring its generic version of Lipitor to market.

Ranbaxy also had to defeat efforts by its competitors to deprive the company of its 180-day generic exclusivity. In particular, Mylan Pharmaceuticals, which also sought to enter the market with a generic Lipitor product, brought suit against the FDA under the Administrative Procedures Act (APA), claiming that the agency should immediately review and deny Ranbaxy’s exclusivity. Mylan also sought a preliminary injunction. Ranbaxy, represented by partners Carlos Angulo and Alexandra W. Miller, intervened as a defendant and, along with the FDA, moved for denial of the preliminary injunction and dismissal of the complaint.

After briefing and argument in which Zuckerman Spaeder participated, the U.S. District Court for the District of Columbia dismissed Mylan’s complaint, holding that Mylan lacked standing to bring its action and that its claims were not ripe for adjudication.

Ultimately, Ranbaxy received not just FDA approval but also its 180 days of exclusivity, to which it was entitled under the statute and which its competitors sought to deny it. Now with the dominant generic version of Lipitor, Ranbaxy is providing an affordable alternative to millions of people worldwide.