DRIVIN G ROWTH - Dr. Reddy's

e disproportionately distributed in the next
four to five years.
To a large extent, the success in generic
will depend on the interpretation of the
patent claim and the ability of lawyers. It is
important to highlight the risks involved in
the generics business, although these are
manageable. The three main risks are:
■ COMPETITION A large part of opportunity in
generics will involve Para IV filing challenges
and technical issues. Although some 60 to 80
products are slated to lose their patents over
the next decade, there are equal if not more
ANDA filings. The latest database on Para IV
filing shows that there are 110 certifications on
different molecules, and companies are looking
as far as 2011 for doing the ANDA filings today.
Success depends upon the quality and speed of
filing. Those are easier said than done.
■ LITIGATION To a large extent, success in
patent challenges depends on the interpretation
of patent claims and the convincing ability of
lawyers — both of which are difficult to
monitor. The cost of litigation is also very high,
and there are several factors which need to be
strategised.
■ REGULATORY FRAMEWORK Regulatory
framework also affects the business. For
instance, there is a proposal making the rounds
in the US to have the 180-days exclusivity
computed from the date of the first judgment.
If this meets regulatory approval, it will
effectively alter the exclusive life of a generic.
cautionary statement
The management of Dr. Reddy’s has prepared
and is responsible for the financial statements
that appear in this report. These financial
statements are in conformity with accounting
principles generally accepted in India and in the
US, and therefore include amounts based on
informed judgments and estimates. The
management also accepts responsibility for the
preparation of other financial information that
is included in this report.
This presentation includes some forwardlooking
statements, as defined in the U.S.
Private Securities Litigation Reform Act of 1995.
The management has based these forwardlooking
statements on its current expectations
and projections about future events. Such
statements involve known and unknown risks,
uncertainties and other factors that may cause
actual results to differ materially. These factors
include, but are not limited to, changes in local
and global economic conditions, the Company’s
ability to successfully implement its strategy, the
market’s acceptance of and demand for its
products, growth and expansion, technological
change and exposure to market risks. By their
nature, these expectations and projections are
only estimates and could be materially different
from actual results in the future.
(1)
(2)
Source: IMS Review, Various web sites on Pharma industry
DR. REDDY’S LABORATORIES LTD. | MANAGEMENT DISCUSSION AND ANALYSIS | ANNUAL REPORT 2001-2002
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