5/16/2014 Sun Pharma settles litigation with Novartis - The Hindu

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Published: May 16, 2014 00:21 IST | Updated: May 16, 2014 00:21 IST
Sun Pharma settles litigation with Novartis
Special Correspondent
Can now launch a generic version of Gleevec
Pharmaceutical major Sun Pharmaceutical Industries has announced a settlement agreement with Novartis
Pharmaceuticals Corporation to dismiss lawsuits filed in the U.S. against Sun with regard to its launch of the generic
version of Novartis Gleevec.
A statement from Sun said its subsidiary had submitted the abbreviated new drug application (ANDA) for the
Gleevec (Imatinib Mesylate tablets) generic version. Gleevec is used in the treatment of chronic myeloid leukemia.
Sun Pharmas subsidiary has tentative approval from the U.S. regulator, US FDA (Food and Drug Administration), for
the generic version of Gleevec.
Under the agreement, Sun Pharmas subsidiary can launch its version of generic Gleevec in the U.S. market on
February 1, 2016. The agreement is subject to customary regulatory approvals and the other terms of the agreement
are confidential, Sun said.
As per IMS data, Gleevec had annual sales of about $2 billion in the U.S.. We had factored launch of generic Gleevec
in July 2015 and had factored revenues of $174 million for a nine-month period, according to Rahul Sharma, a
pharmaceutical sector analyst with Karvy Broking.
With certainty of launch, we factor $82 million sales for a two-month period based on 30 per cent price erosion and
a 35 per cent market share for a two-month period. We are prudent in our market share estimates as this is an
oncology product and scale up may be slower.
Keywords: Sun Pharmaceutical, settlement agreement, lawsuit, Novartis Pharmaceuticals, Gleevec, generic drug
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litigation-with-novartis/article6012983.ece
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