Monday, October 5, 2009

The Combined Merck/Schering-Plough "In Substance" Patent Cliff Table

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 NameSales ($/Yr)Compound NameSuit/Claim Filed30 Month Expiry/
"At Risk" Date
Likely Competitor(s)
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®$3.5BlosartanN/AFebruary 11, 2010dnumerous
Integrilin®$300MEptifibatideFebruary 2009November 2011Teva Pharma
Levitra®$430MVardenafil HClJuly 2009April 2012Teva Pharma
Fosamax®$1.5Balendronate.Lost exclusivity in 2008numerous
Trusopt/Cosopt®$780Mdorzolamide.Lost exclusivity in 2008numerous
Proscar®$320Mfinasteride.Lost exclusivity in 2006numerous
Zocor®$660Mstatin familyLost exclusivity in 2006numerous
Clarinex®$800MDescloratadineSeptember 2006July 2012eOrchid Pharma
Nexium®$1.4BesomeprazoleOctober 2005May 27, 2014fRanbaxy
TOTALS:$16.8 Billion


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.


More to come, as ever.

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