Sanofi sues Glenmark over generic filing on cardiac drug

Ireland drug maker Actavis (Watson) has also been sued by Sanofi for its generic application along with Glenmark.

French drug maker Sanofi has sued  Glenmark over its generic drug filing on cardiac drug Multaq and CNBC-TV18 reports that this suit is an attempt to block entry of cheaper copy-cat versions in the US market.

Glenmark had submitted its application to seek US Food and Drug Administration (USFDA) approval for its generic version of the cardiac drug, which is indicated to reduce hospitalisation risk in cardiac patients. Multaq has annual US sales of USD 320mn.

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Ireland drug maker Actavis (Watson) has also been sued by Sanofi for its generic application along with Glenmark.

Sanofi's base patent on this drug expires in June 2016. Glenmark and Actavis have been sued for later patents. Since the base patent is not part of the suit, it opens doors for generic entry from Glenmark and Actavis post June 2016.

While Actavis in its latest press statement says it believes it may be "first-filer" on Multaq, analysts feel Glenmark too may have this opportunity.

A first-to-file status on generic application allows the generic drug firm 180 days of marketing exclusivity after the innovator patent expiry. All this once the generic version is approved by the USFDA. Glenmark and Actavis are yet to receive final USFDA approval for their generic versions of Multaq.

HSBC Securities in a note says, "We believe Glenmark in a shared FTF scenario can generate USD30mn sales assuming 35 percent share and 50 percent price erosion which makes it a sizeable filing."

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