Nasonex, Merck

Nasonex (mometasone furoate monohydrate)
Respiratory Allergies
Global Sales 2012:
$1.268 billion
U.S. Sales 2012: $597 million
Expiration Date: January 2014 (pediatric exclusivity)

Merck ($MRK) has been fighting off would-be patent challengers on Nasonex since it bought Schering-Plough in 2009. That's when Apotex, the Canadian generics maker, notified the company that it intended to knock off the allergy-fighting nasal spray. The drug was already a blockbuster then, and it remains so now, with almost $1.3 billion in 2012 sales, about $600 million of that in the U.S. For the first half of 2013, Nasonex brought in another $711 million.

In mid-2012, the Nasonex defense took a strange twist. A U.S. judge invalidated both patents that expire in 2014, validated the formulation patent that doesn't expire till 2017--and then said that Apotex's version of the drug doesn't, in fact, step on that still-valid patent. Merck appealed, of course, and won an injunction against Apotex's version till the appeal was resolved. And then in June 2013, the appeals court dealt a final verdict: Apotex's version wouldn't infringe on Merck's patent.

So, while Merck's 2017 patent remains in effect, Nasonex will face a knockoff version much sooner than that. The company's pediatric exclusivity on Nasonex expires in January 2014, so, provided Apotex has its FDA approval in hand, it's good to go at that point.

Merck admits that it has exhausted its appeals and as of the end of the second quarter was warning that it might have to take an impairment charge against the value of Nasonex. Meanwhile, the company has still been pushing Nasonex to consumers. Merck spent $23.9 million during the first half of 2013 on DTC advertising for the drug.

For more:
Special Report: Top 10 DTC Pharma Advertisers: H1 2013 - Merck
Merck loses a patent ruling on blockbuster Nasonex
Merck CEO assures shareholders there is life after death of Singulair patent
Merck to slash 8,500 more jobs in $2.5B global overhaul
Suffering from generic onslaught, Merck cuts sales forecast

-- Tracy Staton (email | Twitter)

Nasonex, Merck