Thomson Scientific Introduces a New Quarterly Report Identifying the 'Movers and Shakers' in the U.S. Generics Industry
January 09 2008 - 12:00AM
PR Newswire (US)
Report Draws On Strategic Intelligence and Competitive Analysis
Information From Newport Horizon Global(TM) PHILADELPHIA and
LONDON, Jan. 9 /PRNewswire-FirstCall/ -- Thomson Scientific, part
of The Thomson Corporation (NYSE: TOC; TSX: TOC) and leading
provider of information solutions to the worldwide research and
business communities, has released the first issue of Movers and
Shakers. This newest report in the Pharma Matters series analyzes
the U.S. generics market from July to September 2007, profiles some
of the companies breaking into the market, and highlights molecule
patents currently being challenged. Movers and Shakers reviews the
U.S. generics market using strategic intelligence and competitive
analysis information drawn from Thomson Scientific's Newport
Horizon Global, the critical product targeting and global business
development system from the industry authority on the global
generics market, in order to assess one of the world's most
important pharmaceutical markets. "Because of the dynamic nature of
the generics market in the U.S., the common perception is that the
market is relatively easy to break into," said Kate Kuhrt,
director, Generics and API Intelligence, Thomson Scientific.
"However, our research has shown that there is huge competition
between the incumbents and new companies vying for a slice of the
market, and clearly there will be winners and losers. Ours is the
first quarterly report to identify the real 'movers and shakers'
within the generics market." The first quarterly report covers the
period of July to September 2007, and highlights the key indicators
of the state of play of the industry. These are: Abbreviated New
Drug Applications (ANDA): An ANDA is the first step in the process
a company needs to follow in order to release a generic drug in the
U.S. and is submitted to the FDA to prove that the generic version
is equivalent to the brand name drug (reference listed drug).
Paragraph IV challenges: A generic company may obtain FDA approval
before patent expiry if it certifies its product does not infringe
the listed patents or the patents are invalid (paragraph IV
certification). In addition, the first company to file an ANDA with
paragraph IV certification is awarded a 180-day period of
exclusivity for the ensuing generic product, giving the filer an
important competitive advantage. Bioequivalent generic versions of
drugs that are not protected by patents can be produced and
marketed in the U.S. by any company, subject to FDA approval. Who
Are the Movers and Shakers This Quarter? Molecules recently exposed
to paragraph IV challenges: Big Pharma companies such as
sanofi-aventis, Eli Lilly, Hoffmann-La Roche and AstraZeneca all
saw challenges in the period from July to September on molecules
they have patented. Companies taking their first steps into the US
generics industry: The report highlights companies that were felt
to be of significant interest. This quarter, the report focuses on
Dabur India Ltd, who launched a Paragraph IV challenge on the drug
oxaliplatin, Zhejiang Huahai Pharmaceutical Group Co Ltd, a Chinese
company that has received tentative approval for nevirapine 200mg
tablets under the President's Emergency Plan for Aids Relief
(PEPAR) program, and GeneraMedix Pharmaceuticals Inc., an American
company based in New Jersey that has received FDA approval for a
selection of new products. "The global stakes involved in the US
generics market become evident when you see that the top country
filing ANDAs in the US is India, and the company recorded as having
the most Paragraph IV patent challenges is Teva, an Israeli Pharma
company," added Kuhrt. "Clearly, the message is that American
companies cannot presume that they will have a home advantage in
this market." About This Quarterly Report: Data for this report was
compiled and analyzed using Newport Horizon Global(R) a critical
product targeting and global business development system from
Thomson Scientific. Created specifically for generic pharmaceutical
companies and strategic API manufacturers, it allows them to
identify and evaluate product opportunities worldwide, ensuring
they will be the first to find the generic product and niche
opportunity, first to make the deal, and first to get to market.
For a copy of the full report with analysis, visit: (To view the
following url, please copy and paste it into a new browser.)
http://scientific.thomson.com/thomsonpharma/media/pdfs/tpqr/m-a-s-jul-
sep07.pdf About The Thomson Corporation The Thomson Corporation
(http://www.thomson.com/) is a global leader in providing essential
electronic workflow solutions to business and professional
customers. With operational headquarters in Stamford, Conn.,
Thomson provides value-added information, software tools and
applications to professionals in the fields of law, tax,
accounting, financial services, scientific research and healthcare.
The Corporation's common shares are listed on the New York and
Toronto stock exchanges (NYSE: TOC; TSX: TOC). Thomson Scientific
is a business of The Thomson Corporation. Its information solutions
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at scientific.thomson.com. DATASOURCE: The Thomson Corporation
CONTACT: Eoin Bedford of Thomson Scientific, +44-207-433-4691, Web
site: http://www.scientific.thomson.com/ http://www.thomson.com/
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