The Delhi-based Pharma Company, Morepen Laboratories
has completed an export of $15 million
of Loratadine, an antihistamine to international
market since January this year. Morepen Laboratories had
an arrangement with Geneva Pharma, the first ANDA filer
as the sole supplier for Loratadine. Geneva had six month
exclusivity on marketing Loratadine which came to an end
recently. Morepen has started receiving fresh orders from
other bulk drug companies like Genpharm, and would clock
a business of more than $20 million in the current calendar
year. The prices of Loratadine have also stabilized in
international market and have not come down in spite of
end of the exclusivity period.
Morepen has already launched Ranitidine
an anti-ulcer drug in US market through MorepenMax, a
joint venture company between Morepen and Florida based
DrugMax. Morepen is also getting ready to file the ANDA
for Loratadine and Atorvastatin in the US market. Atorvastatin
is the no 1 drug world over and has a market size of more
than US$ 10 billion. Morepen has a process patent for
Atorvastatin Calcium for new and improved process for
preparation of amorphous form of Atorvastatin Calcium.
Morepen Laboratories has also filed the DMF (Drug master
file) for the drug Fluvastatin Sodium, a cholesterol-lowering
drug which belongs to Statin family, in Canada. This drug
has an estimated market size of $ 500 million globally
and is growing at the rate of 25%. The company is also
ready to file the DMF for and Des Loratadine, an anti
histamine,
Loratadine had gone off-patent in December and has become
the over the counter (OTC) product in December 2002, resulting
in huge surge in demand for the drug.
Morepen is well placed to reap the benefits due to its
significant Loratadine capacities (24 tonnes per annum)
and various international tie-ups including that with
Geneva Pharma and Gen Pharma. Morepen stands to gain immensely
as it is the only US Food and Drug Administration (USFDA)
approved API facility in India and the largest generic
facility in the world. The company is already making the
drug in the domestic market from the basic stage and since
there are no other USFDA approved plants for Loratadine
in India, there is virtually nil competition. Morepen
is already exporting bulk Loratadine to a number of non-patented
markets and has around 28 registrations in European market.