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United States. Food and Drug Administration

Ranbaxy Loses 180-Day Exclusivity to Sell Generic Nexium in US Market

Strategic Insights

— 2 min read

Pharmaceutical company Ranbaxy has lost its 180-day exclusivity to sell a generic version of AstraZeneca's heartburn drug Nexium in the US market, according to a filing on the Bombay Stock Exchange (BSE). The US Food and Drug Administration (FDA) has determined that Ranbaxy has forfeited its exclusivity for the generic version of Nexium, a proton pump inhibitor used to treat gastroesophageal reflux disease (GERD). This decision comes as a blow to Ranbaxy, which had been seeking to launch the generic version of Nexium in the US market. In contrast, Israel-based Teva Pharmaceutical Industries has received approval from the FDA to launch a generic version of Nexium, and is preparing to do so in the near future.

Key Takeaways:

  • Ranbaxy has lost its 180-day exclusivity to sell a generic version of AstraZeneca's heartburn drug Nexium in the US market.
  • The US Food and Drug Administration (FDA) has determined that Ranbaxy has forfeited its exclusivity for the generic version of Nexium.
  • Israel-based Teva Pharmaceutical Industries has received approval from the FDA to launch a generic version of Nexium.
  • Ranbaxy had been seeking to launch the generic version of Nexium in the US market, but its plans have been foiled.
  • The company is pursuing all available legal options to preserve its rights.
  • The approval of Teva's generic version of Nexium is the first generic equivalent to Nexium by the FDA.
  • The annual sales of Nexium in the US are approximately $6 billion, according to IMS data as of November 2014.
  • Ranbaxy had faced criticism over a patent settlement involving "pay-for-delay" with AstraZeneca, where it was claimed the company received nearly $1 billion to delay the launch of its generic Nexium.
  • A US federal court had ruled that the patent settlement was not anti-competitive, and the suit had been dismissed.

Statistics:

  • The annual sales of Nexium in the US are approximately $6 billion, according to IMS data as of November 2014.
  • Ranbaxy had faced criticism over a patent settlement involving "pay-for-delay" with AstraZeneca, where it was claimed the company received nearly $1 billion to delay the launch of its generic Nexium.
  • The approval of Teva's generic version of Nexium is the first generic equivalent to Nexium by the FDA.
  • Ranbaxy Lab shares ended at Rs 706.90 on BSE.

Sources:

  • Diligent Media Corporation Ltd., DNA (Daily News & Analysis) - "Ranbaxy loses 180-day exclusivity to sell generic Nexium in US market"
  • IMS data - "Nexium annual sales in the US are approximately $6 billion as of November 2014"
  • Contify.com - "Teva gets FDA approval to launch generic Nexium"
  • AstraZeneca - "Nexium patent settlement with Ranbaxy"
  • US federal court - "Ruling on AstraZeneca-Ranbaxy patent settlement"

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