As promised, here is the combined Merck/Schering-Plough "in substance" patent cliff data, in one handy table. Let me know if you see errors in it, but $16.8 billion of sales at risk, or already under attack by generics seems significant -- to me -- at least.Branded Name Sales ($/Yr) Compound Name Suit/Claim Filed 30 Month Expiry/
"At Risk" DateLikely Competitor(s) Singulair® $4.3B montelukast February 2007 August 22, 2009a Teva Zetia® $900M Ezetimibe March 2007 October 2009b Glenmark Pharma Primaxin® $760M imipenem/cilastatin January 2007 September 1, 2009c Ranbaxy Labs Temodar® $950M Temozolomide July 2007 January 2010 Barr Labs (Teva Pharma) Emend® $264M aprepitant January 2009 June 2011 Sandoz Cozaar® $3.5B losartan N/A February 11, 2010d numerous Integrilin® $300M Eptifibatide February 2009 November 2011 Teva Pharma Levitra® $430M Vardenafil HCl July 2009 April 2012 Teva Pharma Fosamax® $1.5B alendronate . Lost exclusivity in 2008 numerous Trusopt/Cosopt® $780M dorzolamide . Lost exclusivity in 2008 numerous Proscar® $320M finasteride . Lost exclusivity in 2006 numerous Zocor® $660M statin family Lost exclusivity in 2006 numerous Clarinex® $800M Descloratadine September 2006 July 2012e Orchid Pharma Nexium® $1.4B esomeprazole October 2005 May 27, 2014f Ranbaxy TOTALS: $16.8 Billion
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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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More to come, as ever.
Monday, October 5, 2009
The Combined Merck/Schering-Plough "In Substance" Patent Cliff Table
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