Ranbaxy Pharmaceuticals Receives FDA Approval for Generic Lipitor

Strategic Insights -

Ranbaxy Pharmaceuticals Inc., a subsidiary of Ranbaxy Laboratories Ltd., has received final approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Atorvastatin, the generic equivalent of Lipitor. This approval enables Ranbaxy to launch the product in the U.S. market, providing a safe, effective, and affordable alternative to the branded medication. Atorvastatin is a cholesterol-reducing medicine that has the potential to benefit millions of Americans.

Key Takeaways:

  • Ranbaxy Pharmaceuticals Inc. has received final approval from the FDA to manufacture and market Atorvastatin, a generic version of Lipitor, a cholesterol-reducing medication.
  • Atorvastatin is the generic equivalent of Lipitor, which generated total annual sales of $7.89 billion in the United States through September 2011.
  • Pursuant to an agreement with Teva Pharmaceuticals USA, Inc., a portion of the profits from sales of Atorvastatin will be paid to Teva during Ranbaxy's 180-day first-to-file exclusivity period.
  • Ranbaxy Pharmaceuticals Inc. is a wholly owned subsidiary of Ranbaxy Laboratories Limited, India's largest pharmaceutical company.
  • Ranbaxy Laboratories Limited is an integrated, research-based, international pharmaceutical company producing a wide range of quality, affordable generic medicines.
  • Ranbaxy's focus on research and development has resulted in several approvals, including those that incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies developed at its own labs.
  • Mr. Arun Sawhney, CEO & Managing Director of Ranbaxy, stated that Atorvastatin helps millions of Americans manage healthy cholesterol levels and that the company is committed to continuing to expand its portfolio of products offered in the U.S. market.

Statistics:

  • Total annual sales of Lipitor in the United States through September 2011: $7.89 billion.1
  • Ranbaxy Pharmaceuticals Inc. is based in Jacksonville, Florida.
  • Ranbaxy Laboratories Limited is India's largest pharmaceutical company.

Sources:

1. Source: Ranbaxy Press Release, "Ranbaxy Announces Final Approval for Atorvastatin From the U.S. FDA and Launches Product in the U.S. Market," 2011.

*Note: The source date is November (2011) but the exact date in November is not specified.*