A US court has ordered generic drug makers including Mylan, Dr Reddy’s Laboratories, Aurobindo Pharma, and Torrent Pharma to stop selling a copy of Gilenya, for which Novartis holds the patent.

The annual sales of Gilenya, a drug used to treat multiple sclerosis, was about $3.3 billion in 2018 and the judge pegged the cumulative loss of opportunity on generic drug makers at $50 million.

Novartis has sought to extend its patent on Gilenya beyond 2027, and the deadline to appeal for the extension ends this year. The patent case is still under trial.

Double blow

The court verdict has come a day after an Indian broking house, India Infoline (IIFL) downgraded Dr Reddy’s by a notch. “The company’s market share uptake in Suboxone has been slow, and the key product filings of Nuvaring and Copaxone have also seen some delays,” the report said.

It has been a double whammy for Aurobindo Pharma too. The US Food and Drug Administration (USFDA) has issued a warning letter for one of the company’s unit in Srikakulam in Andhra Pradesh. The unit, which manufactures active pharmaceutical ingredients, was inspected by the American drug regulator in February 2019 after the ‘sartan’ recall.

“Our analysis of 34 WLs and interactions with the company suggest that the facility will be allowed to continue supplying existing molecules. However, future approvals will be withheld until the issues are resolved. There are 12 ANDAs (generic drug applications), including one injectable, pending from Unit 11, of which seven approvals were expected in FY20 and five in FY21. While a majority of these filings are „me too‟ products, there are a few that represent an $10mn+ opportunity annually,” a report from SBI Cap Securities said, adding that if the warning escalated to a import ban into the US from the said facility, it could lead to 15% to 20% fall in earnings.

Source: https://www.businessinsider.in/mylan-dr-reddys-aurobindo-and-torrent-pharma-cant-sell-generic-gilenya-that-is-patented-by-novartis/articleshow/69951402.cms