Tuesday, December 24, 2013

Merck's 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. International March 2011 backgrounder here.

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.


Anonymous said...

Happy holidays, Condor. Related story link without much difference from Bloomberg other than a comment mentioning an investigative piece on Nuvaring in Vanity Fair. Interesting stuff.


Condor said...

Thanks so much -- talk to you Thursday!

Grinch is on!