Here it is (updated to include Impax's intended incursion into Vytorin®'s markets) -- do let me know, if you see any errors:Branded
NameGlobal Sales
($/Yr)Compound
NameSuit/Claim
Filed30 Month Expiry/
"At Risk" DateLikely
Competitor(s)Singulair® $4.3B montelukast February 2007 August 22, 2009a Teva Vytorin® $1.8B simvastatin/ezetimibe August 2010 November, 2013 Impax Zetia® $2.0B ezetimibe March 2007 October 2009b Glenmark Pharma; Mylan; Teva 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/Hyzaar® $3.5B losartan . 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; new drugs: Glaxo & Amgen Heartgard® $500M ivermectin . Lost exclusivity in 2009e numerous Frontline® $500M fipronil . March 2010e 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 2012f Orchid Pharma Nexium® $1.4B esomeprazole October 2005 May 27, 2014g Ranbaxy TOTALS: $20.7 Billion
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Note a: Trial completed February 2009; Teva's appeal of trial decision (in favor of patent holders) is now pending; no launch yet, despite window being open since August 22, 2009.
Note b: Trial may begin in Q4 2010; 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: The basic Cozaar/Hyzaar patents in Europe expired in February 2010, and the US patents expire in April 2010. Many likely competitors after those dates.
Note e: Both Frontline and Heartgard -- the core, non-combination Animal Health products -- were off-patent by the end of Q1 2010: Frontline (non-combination product) came off patent in the USA during March of 2010. Heartgard returns from Merial, as half of the New Merial JV; half of the Intervet Frontline sales will go to Sanofi-Aventis, under that same new JV. The sales figures in the above table include only Merck's share of the New Merial joint venture.
Note f: 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 g: 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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Friday, August 20, 2010
Merck's $20.7 Billion Patent Cliff (!) Table -- UPDATED, For The Patent Perils Of Vytorin®
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