Sandoz Becomes First and Only Company to Receive FDA Approval for Generic Tacrolimus

Novartis AG's Sandoz unit said Tuesday it launched a generic version of the drug Prograf, which is used to help prevent rejection of a transplanted kidney or liver.

The drug, also called tracrolimus, suppresses the immune system to keep it from attacking the transplanted organ. Novartis ( NVS- news - people ), which is based in Switzerland, said U.S. sales of the drug totaled $929 million in the 12 months ended April 30. Sandoz will market the drug in 0.5 mg, 1 mg and 5 mg capsules , Forbes reports.

Meanwhile, coinciding with the Tokyo-based pharmaceutical maker's rejected petition, Swiss-based Novartis AG (NVS) said Tuesday its subsidiary Sandoz became the first and only company to receive FDA approval for generic Tacrolimus.

Competition with Sandoz is sure to deal a blow to Astellas' sales of Tacrolimus, marketed under the product name Prograf, in coming years as much lower prices typically prompt patients to quickly shift to generic versions in the U.S. market ,Wall Street Journal reports.

However, Astellas lost U.S. patent protection for Prograf in April 2008 but until now has not faced any generic competition. The generic version was launched by Novartis' Sandoz division.

The blow comes amid development setbacks for Japan's second-largest drugmaker which also faces the expiry of the U.S. patent for its Flomax urinary drug in October. Flomax accounts for around 12 percent of Astellas' sales.

Despite the stock's dive on the threat of a generic rival to Prograf, analysts generally doubt competition will reduce Prograf's revenues by much in the near term , Reuters reports.

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