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


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
Name
Global Sales
($/Yr)
Compound
Name
Suit/Claim
Filed
30 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/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


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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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