• Fluvastatin is a cholesterol Lowering drug from
statin family; Patent expires in 2003/2004, hence
quick entry product in Europe and Canadian market.
• Morepen has orders lined up from top generic companies
in Europe for post patent period
• Morepen is the only generic manufacturer of this
product worldwide.
• This is the tenth patent of Morepen after Atorvastatin
Calcium, Desloratadine, Loratadine and others:
Three more PCTs are under filing.
Morepen Labs Limited filed International process and product
patent for the drug Fluvastatin Sodium, the next block
buster drug from Morepen stable. This is the tenth patent
filed by Morepen and the fourth in a period of less than
a year. Morepen Laboratories Ltd. is known to develop
non-infringing processes of high value synthetically complex
bulk drugs. Fluvastatin is cholesterol-lowering drug and
belongs to the Statin family and has an estimated market
size of US $ 500 million globally that is growing at the
rate of 25%. Morepen is the only generic manufacture of
this product worldwide. Since the patent expiry of the
product is by end of this year, a number of Canadian &
European customers are working with Morepen to launch
the generic version after the patent expiry. Morepen already
has a process patent in the statin family for amorphous
and polymorph form of Atorvastatin, the no 1 drug globally
and Fluvastatin is the second one.
Speaking on the development Mr. Sushil Suri, CMD Morepen
Labs said, "Morepen is the only player of fluvastatin.
This block- buster molecule will give us quick entry into
statins market resulting in good revenues for the company
in near future owing to an early patent expiry, thus contributing
to the bottom-line of the company".
This new polymorph (crystalline) form of the drug developed
by Morepen is an improved version of fluvastatin Sodium,
which bestows greater yield of highly pure form that has
very minuscule values of left over solvents and degradation
products. The process ensures speed and consistency of
production that is vital for improving the commercial
viability of manufacturing the product. Development of
non-infringing processes and new polymorphs with patent
protection will provide Morepen a competitive edge to
capture major generic market share. Sandoz of USA is the
innovator of the product and the patent expires in 2003/2004
in Europe and Canada.
The drug is widely used in the treatment of hyperlepidemia
and hypercholesterolemia. The high order of efficacy and
safety has made Fluvastatin a popular and prescribed product
in the US, Europe and Canada. The company already has
Technical package and is in the process of preparing for
DMF to see the product sail through easily, both in regulated
and non-regulated markets. Morepen has already started
supplying the product to Latin American countries and
have tied up with major European and Middles East Pharma
Companies
The other patents granted to or filed by Morepen are
for Atorvastatin Calcium -for new and improved process
for the preparation of Atorvastatin calcium amorphous,
Atorvastatin Calcium - for a novel process for the preparation
of new polymorph of Atorvastatin calcium, Loratadine -
for an improved process for the production of Loratadine
and Desloratadine for improved process. In the area of
formulation, Morepen has filed PCTs for method of preparation
of garlic ointment for topical use in skin infection and
Cotrimoxazole for method of preparation of antibacterial
gel.
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