Saturday, March 13, 2010

UPDATED -- "New" Merck's Patent Cliff Table: $17.8 Billion In Annual Revenue Now At Risk

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:

Global Sales
30 Month Expiry/
"At Risk" Date

Singulair®$4.3BmontelukastFebruary 2007August 22, 2009aTeva
Zetia®$900MezetimibeMarch 2007October 2009bGlenmark Pharma
Primaxin® $760Mimipenem/cilastatinJanuary 2007September 1, 2009cRanbaxy Labs
Temodar®$950MtemozolomideJuly 2007January 2010Barr Labs (Teva Pharma)
Emend®$264MaprepitantJanuary 2009June 2011Sandoz
Cozaar/Hyzaar®$3.5Blosartan.February 11, 2010dnumerous
Integrilin®$300MeptifibatideFebruary 2009November 2011Teva Pharma
Levitra®$430Mvardenafil HClJuly 2009April 2012Teva Pharma
Fosamax®$1.5Balendronate.Lost exclusivity in 2008Numerous; new drugs: Glaxo & Amgen
Heartgard®$500Mivermectin.Lost exclusivity in 2009enumerous
Frontline®$500Mfipronil.March 2010enumerous
Trusopt/Cosopt®$780Mdorzolamide.Lost exclusivity in 2008numerous
Proscar®$320Mfinasteride.Lost exclusivity in 2006numerous
Zocor®$660Mstatin familyLost exclusivity in 2006numerous
Clarinex®$800MdescloratadineSeptember 2006July 2012fOrchid Pharma
Nexium®$1.4BesomeprazoleOctober 2005May 27, 2014gRanbaxy
TOTALS:$17.8 Billion


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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