Tuesday, March 2, 2010

Orchid Wins FDA Nod For Desloratadine -- A Generic Version Of Clarinex® 5mg Tabs


You'll likely recall that legacy Schering-Plough (now New Merck) signed a series of "pay for delay" deals -- related to the Clarinex® patents -- back in August of 2009. The last party to settle was Orchid Pharmaceuticals. If these "pay for delay" agreements are held enforceable, the earliest any of these generic manufacturers could market a US version of the Clarinex pills would be mid-2012. That may be a big if, though -- given recent US health care delivery reform developments.

Overnight, we learn that India's Orchid Pharmaceuticals has received FDA approval for a 5 mg desloratadine tablet -- desloratadine is the chemical name for the active ingredient in Merck's Clarinex. This could prompt FTC to accelerate its review of the Clarinex agreements, and might suggest that Orchid could save the US consumers millions, if the FTC were to act promptly, in encouraging New Merck to "revisit" the old Schering-Plough pay for delay agreements. Per Bloomberg TV, overnight, then:

. . . .Orchid Chemicals and Pharmaceuticals advanced 1.59%, after the company got final approval from US Food & Drug Administration for Desloratadine tablets in 5 milligram strength. . . .

Stay tuned.

2 comments:

Anonymous said...

Because loratadine and desloratadine are essentially the same; http://en.wikipedia.org/wiki/Desloratadine#Desloratadine_vs._loratadine and Claritin/generic are available over the counter....

why the push for generic desloratadine? Other then coverage by an insurance company-

Condor said...

It is insurance, and related co-pays:

. . . .There is no clinical advantage to switching a patient from loratadine to desloratadine. However, it may be an option for patients whose medical insurance no longer covers loratadine if the co-pay is less than the cost of the over-the-counter product. . . .

Am Fam Physician 68 (10): 2015–6 (2003)

Great question! Do stop back!

Namaste