Here it is (updated to include Impax's intended incursion into Vytorin®'s markets) -- do let me know, if you see any errors:
Branded Name | Global Sales ($/Yr) | Compound Name | Suit/Claim Filed | 30 Month Expiry/ "At Risk" Date | Likely 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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