jueves, 15 de octubre de 2009

Merck/Schering -Plough: "Negra sombra"

The Combined Merck/Schering-Plough "In Substance" Patent Cliff Table

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$16.8 Billion "en el aire"...


Note a:
Trial completed February 2009; awaiting decision; no launch yet, despite window being open since August 22, 2009.

Note b: Trial could begin by year end 2009; though admittedly unlikely, an "at risk" launch (by Glenmark, most likely) "window" will be open -- and could occur at any time, now.

Note c: By agreement, Ranbaxy may launch September 1, 2009.

Note d: First Cozaar patents expire in February and April 2010. Many likely competitors after those dates.

Note e: All potential generic descloratadine manufacturers have agreed to a launch suspension until at least January 2012 (Orchid -- the one most likely to launch -- will wait, per agreement, until July 2012), though the permissive "at-risk" launch window first-opened in July of 2009.

Note f: Despite the "at risk" launch window opening in April of 2008, Ranbaxy and Merck (along with partner AstraZeneca) entered a settlement agreement keeping a generic form of Nexium off the market until May of 2014. The United States Federal Trade Commission (the "FTC") is now formally investigating this settlement agreement -- looking into, among other matters, its potential for improper anticompetitive effects. In that regard, Merck and AstraZeneca each received an investigative document demand from the FTC -- in July 2008 -- regarding the settlement agreement with Ranbaxy. Merck is cooperating with the FTC in responding to the document demand.



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