Here it is (updated to include New Merial joint venture animal health products -- Heartgard and Frontline, as well as update the footnotes on status of various pieces of patent litigation) -- do let me know, if you see 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 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/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: $17.8 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 could begin by mid-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 -- are now off-patent. Frontline (non-combination product) is coming 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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Showing posts with label UPDATED PATENT CLIFF TABLE March 13 2010. Show all posts
Showing posts with label UPDATED PATENT CLIFF TABLE March 13 2010. Show all posts
Saturday, March 13, 2010
UPDATED -- "New" Merck's Patent Cliff Table: $17.8 Billion In Annual Revenue Now At Risk
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