Tuesday, September 29, 2009

An Evolving Work-In-Progress -- Of Merck's "In-Substance" Pending-Patent Cliffs


This draft below will soon be integrated with the earlier Schering-Plough "in substance" patent cliff table -- to set forth the "New Merck" in-substance patent cliff picture -- in one plain-English, and convenient summary table. Let me know if any of you see any errors in the work thus far ("Old" Merck, only here):

Brand Name2008 SalesChemical NameClaim First Filed30 Month Expiry/
At-Risk Date
Likely Competitor
Singulair® $4.3BmontelukastFebruary 2007August 22, 2009aTeva
Primaxin® $760Mimipenem/cilastatinJanuary 2007September 1, 2009bRanbaxy Labs
Cozaar® $3.5BlosartanN/AFebruary 11, 2010cMultiple
Emend® $264MaprepitantJanuary 2009June 2011Sandoz
Nexium® $1.4BesomeprazoleOctober 2005May 27, 2014dRanbaxy
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
TOTAL:$13.4 Billion


~~~~~~~~~~

Note a: Trial completed February 2009; awaiting decision; no launch yet, despite window being open since August 22, 2009.

Note b: By agreement, Ranbaxy may launch September 1, 2009.

Note c: First Cozaar patents expire in February and April 2010. Many likely competitors after those dates.

Note d: Despite the in-substance launch window opening in April of 2008, Raxaby 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.

2 comments:

Anonymous said...

and then there's this: http://www.nj.com/news/index.ssf/2009/09/nj_supreme_court_upholds_45m_a.html

N.J. Supreme Court upholds $4.5M award for widow of Vioxx victim
By The Associated Press
September 29, 2009, 1:34PM

TRENTON -- The Supreme Court of New Jersey backed a $4.5 million award to the widow of a man who suffered heart problems after using Merck's painkiller Vioxx.

Condor said...

Yep.

The Vioxx liability may ultimately double in size, from the $4.5 billion now set aside for the class settlement. How so?

Well, as various plaintiffs "opt out" of the global settlement, and choose individual routes through the legal maze -- in each state, the number will undoubtedly grow. By how much?

No one really knows.

That "opt out", though, is a right each plaintiff will retain, at least until he or she finally "opts into" the class settlement.

Thanks -- do stop back!

Namaste