NuvaRing® (From Legacy Schering-Plough) Subject to Hatch-Waxman Challenge: $600 Million In Sales At Risk

This is not a near term problem, as these proceedings are highly unlikely to be resolved much before mid-2016. But the longer-term outlook for NuvaRingTM was cloudy, even before this development.

It is possible that Merck might settle, and allow the generic version on market in the US just a tad earlier, given the flattened sales, and the increasing ramp of lawsuits in the US — related to NuvaRing. We shall see.

Here is Bloomberg, on the Warner-Chilcott vs. Merck Hatch-Waxman proceedings. We will keep an eye on it for you:

. . . .The lawsuit filed today in federal court in Delaware accuses Warner Chilcott of attempting to market the generic before the expiration of Whitehouse Station, New Jersey-based Merck’s patent in 2018.

Actavis, which has global headquarters in Dublin, said in a statement that it may be the first company to file a new drug application with the U.S. Food and Drug Administration for generic versions of the contraceptive.

NuvaRing is a combined hormonal vaginal contraceptive ring that includes both estrogen and progestin to prevent pregnancy. The product, which was linked in a 2011 FDA report to a higher risk for blood clot complications, had sales of $492 million through the third quarter. . . .

Have a peaceful and joyous Noel, one and all. I’m out.


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