Morepen Laboratories Limited has filed its second DMF
for the amorphous form of Atorvastatin Calcium (Lipitor)
and becomes the second company to plan entry into US Generic
market for this drug after Ranbaxy Laboratories. Lipitor
is Pfizer’s biggest money spinner and the largest
molecule in the world with a market of a whopping USD
10 billion (Rs.44,000 crores)
Last Quarter Morepen Labs had filed US DMF for its own
patented new Crystalline Form VI of Atorvastatin Calcium.
With the current filing Morepen has consolidated its position
since it can now offer both the Crystalline and Amorphous
forms in the US market. DMF filings are currently underway
in the European Union.
The generic version of this cholesterol reducing drug
can be launched once the litigations of the Para IV challenge
are over in the US. The first player, Ranbaxy is currently
engaged in a legal fight with Pfizer with the Amorphous
form of Atorvastatin in a District court at Delaware in
the United States. “While the outcome of the trial
is difficult to predict at this point, if Ranbaxy manages
to win, floodgates would then open for other generic players
of Atorvastatin to enter the market” said Mr. Sushil
Suri, Chairman and Managing Director.
Morepen is poised to leverage the Atorvastatin opportunity
even earlier in Europe. “We are in an advanced stage
of tying up with marketing partners. Our Crystalline Form
VI which has excellent stability results is being evaluated
by different generic players who are waiting for clarity
to emerge as the generic Atorvastatin opportunity unfolds”
according to Dr Chandrasekhar N K , VP – Business
Development.
In Europe two generic Companies, have already launched
the Amorphous form of Atorvastatin in the Czech Republic
and Slovakia. Pfizer has been unable to restrain them
legally from launching their product. Ranbaxy and Morepen
are hoping this will happen in the US too.
Both the forms have already been commercialized at Morepen’s
plants in Himachal Pradesh putting them in a state of
readiness to be off the blocks as the first in the race
for supplying the API in bulk quantities as soon as Lipitor
goes generic.
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Contact :
T.B. Kaveri
Morepen Laboratories Limited
416-418, Antriksh Bhawan
22, K.G. Marg,
New Delhi – 110 001
Tel : 011 23324443, 23712025
Cell: 00919818305894
