A dispute over the patent covering AstraZeneca's Crestor in the US may negatively impact generic companies awaiting FDA approval to launch their versions of the statin in the country, reported The Times of India.
Several generic companies, including Sun Pharma, Aurobindo, Glenmark, Torrent and Alkem, were expected to enter the market once the regulator granted "final" approval on their generic-drug applications by July 7.
However, AstraZeneca is suing the FDA to prevent entry of generic Crestor in the US, citing a recently granted orphan drug approval that the company argues could extend its monopoly for all Crestor indications.
"This is an old tactic," commented Sujay Shetty, pharmaceuticals and life sciences leader at PwC India, adding that "the delay in approval [if stretched] will impact earnings [of companies]."
Meanwhile, ICICI Securities analyst Siddhant Khandekar suggested "those [Indian] players which have a smaller US play overall, could be the biggest beneficiary in this case," with the news source naming Torrent as one such example.
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