Teva is in the driver's seat, now in the US -- as its generic version of Merck's Cozaar® blood pressure medicine looks to be approved by the FDA early next month -- thus giving it six-months of exclusive sales of the triple blockbuster, in generic form. US consumers will likely see a more than 50 percent drop in the price of the medicine, almost immediately.
This snippet, from an Israeli online paper, overnight -- do go read it all:
. . . .Teva said that the US Court of Appeals for the District of Columbia Circuit has overturned a July 31, 2009 district court decision which held that Teva forfeited 180-day marketing exclusivity for its generic versions of Merck's hypertension drugs Hyzaar (hydrochlorothiazide; losartan potassium) and Cozaar (losartan potassium).
Teva’s abbreviated new drug applications will be eligible for final approval in April 2010. Teva says it should be eligible to receive 180-day Hatch-Waxman statutory exclusivity to market these products.
Based on IMS data, annual US sales of the branded Merck products were about $1.5 billion in 2009.
Teva's lawsuit will now be remanded to the district court for the entry of relief consistent with today's decision.
Shares in Teva rose 0.56% to $60.95 yesterday, giving a market cap of $53.94 billion. Teva shares ended last year at a price of $56.18. . . .[And, from other online reports, here:]
In a Tuesday report, Citigroup analysts said that the ruling "put upside pressure on 2010 estimated earnings per share." Analysts estimate the ruling adds 10 cents to 15 cents a share to the brokerage's current 2010 estimate of adjusted earnings of $4.50. The Citigroup analysts affirmed their buy rating and $67 price target.
UBS analyst Marc Goodman also said the ruling presented a "nice upside surprise," perhaps adding as much as 16 cents to 2010 earnings. The analyst affirmed his buy rating and $70 price target. . . .
Sweet. This appelate ruling may also -- for six months, at least -- slightly decrease the slope of the branded Cozaar/Hyzaar's sales declines, as Teva will only be able to ship so many pills during that timeframe. Meanwhile, all the other generic manufacturers will have to sit on the sidelines, with their pilled, bottled, packed and palleted offerings in shrinkwrap -- all ready for delivery to US pharmacy distribution centers, come October 2010, when Teva's Hatch-Waxman generic exclusivity period lapses.
But make no mistake here, Teva will keep selling tons of these pills, after that -- as it will have a statutorily-entrenched lead.
[Editor's Note: I decided to upgrade my usual Cozaar-story graphic (top right, which now looks just a little too blandly smooth and shiny), choosing to depict the Cozaar | MRK 951 teardrop-shaped pill as a crumbling castle wall -- being decimated, stone by stone -- by Teva's generic sales. . . .
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