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This excerpt taken from the ELN 6-K filed Mar 30, 2009. Our
industry and the markets for our products are highly
competitive.
The pharmaceutical industry is highly competitive. Our principal
pharmaceutical competitors consist of major international
companies, many of which are larger and have greater financial
resources, technical staff, manufacturing, R&D and
marketing capabilities than Elan. We also compete with smaller
research companies and generic drug manufacturers.
Table of Contents
Risk Factors
A drug may be subject to competition from alternative therapies
during the period of patent protection or regulatory exclusivity
and, thereafter, it may be subject to further competition from
generic products. The price of pharmaceutical products typically
declines as competition increases.
Our product Azactam lost its basic U.S. patent
protection in October 2005. To date, no generic Azactam
product has been approved.
In addition, the U.S. basic patent covering our product
Maxipime expired in March 2007. Maxipime became
subject to generic competition following the expiration of the
basic patent, and that has materially and adversely affected our
sales of Maxipime.
Generic competitors have challenged existing patent protection
for several of the products from which we earn manufacturing or
royalty revenue. If these challenges are successful, our
manufacturing and royalty revenue will be materially and
adversely affected.
Generic competitors do not have to bear the same level of
R&D and other expenses associated with bringing a new
branded product to market. As a result, they can charge much
less for a competing version of our product. Managed care
organisations typically favour generics over brand name drugs,
and governments encourage, or under some circumstances mandate,
the use of generic products, thereby reducing the sales of
branded products that are no longer patent protected.
Governmental and other pressures toward the dispensing of
generic products may rapidly and significantly reduce, or slow
the growth in, the sales and profitability of any of our
products not protected by patents or regulatory exclusivity and
may adversely affect our future results and financial condition.
The launch of competitive products, including generic versions
of our products, has had and will have a material and adverse
affect on our revenues and results of operations.
Our competitive position depends, in part, upon our continuing
ability to discover, acquire and develop innovative,
cost-effective new products, as well as new indications and
product improvements protected by patents and other intellectual
property rights. We also compete on the basis of price and
product differentiation and through our sales and marketing
organisation. If we fail to maintain our competitive position,
then our revenues and results of operations may be materially
and adversely affected.
This excerpt taken from the ELN 20-F filed Feb 26, 2009. Our
industry and the markets for our products are highly
competitive.
The pharmaceutical industry is highly competitive. Our principal
pharmaceutical competitors consist of major international
companies, many of which are larger and have greater financial
resources, technical staff, manufacturing, R&D and
marketing capabilities than Elan. We also compete with smaller
research companies and generic drug manufacturers.
A drug may be subject to competition from alternative therapies
during the period of patent protection or regulatory exclusivity
and, thereafter, it may be subject to further competition from
generic products. The price of pharmaceutical products typically
declines as competition increases.
Our product Azactam lost its basic U.S. patent
protection in October 2005. To date, no generic Azactam
product has been approved.
In addition, the U.S. basic patent covering our product
Maxipime expired in March 2007. Maxipime became
subject to generic competition following the expiration of the
basic patent, and that has materially and adversely affected our
sales of Maxipime.
Generic competitors have challenged existing patent protection
for several of the products from which we earn manufacturing or
royalty revenue. If these challenges are successful, our
manufacturing and royalty revenue will be materially and
adversely affected.
Generic competitors do not have to bear the same level of
R&D and other expenses associated with bringing a new
branded product to market. As a result, they can charge much
less for a competing version of our product. Managed care
organizations typically favor generics over brand name drugs,
and governments encourage, or under some circumstances mandate,
the use of generic products, thereby reducing the sales of
branded products that are no longer patent protected.
Governmental and other pressures toward the dispensing of
generic products may rapidly and significantly reduce, or slow
the growth in, the sales and profitability of any of our
products not protected by patents or regulatory exclusivity and
may adversely affect our future results and financial condition.
The launch of competitive products, including generic versions
of our products, has had and will have a material and adverse
affect on our revenues and results of operations.
Our competitive position depends, in part, upon our continuing
ability to discover, acquire and develop innovative,
cost-effective new products, as well as new indications and
product improvements protected by patents and other intellectual
property rights. We also compete on the basis of price and
product differentiation and through our sales and marketing
organization. If we fail to maintain our competitive position,
then our revenues and results of operations may be materially
and adversely affected.
Table of Contents
This excerpt taken from the ELN 6-K filed Mar 31, 2008. Our
industry and the markets for our products are highly
competitive.
The pharmaceutical industry is highly competitive. Our principal
pharmaceutical competitors consist of major international
companies, many of which are larger and have greater financial
resources, technical staff, manufacturing, R&D and
marketing capabilities than Elan. We also compete with smaller
research companies and generic drug manufacturers.
A drug may be subject to competition from alternative therapies
during the period of patent protection or regulatory exclusivity
and, thereafter, it may be subject to further competition from
generic products. The price of pharmaceutical products typically
declines as competition increases.
Our product Azactam lost its basic U.S. patent
protection in October 2005. To date, no generic Azactam
product has been approved.
In addition, the U.S. basic patent covering our product
Maxipime expired in March 2007. Maxipime became
subject to generic competition following the expiration of the
basic patent, and that has materially and adversely affected our
sales of Maxipime.
Generic competitors have challenged existing patent protection
for several of the products from which we earn manufacturing or
royalty revenue. If these challenges are successful, our
manufacturing and royalty revenue will be materially and
adversely affected.
Generic competitors do not have to bear the same level of
R&D and other expenses associated with bringing a new
branded product to market. As a result, they can charge much
less for a competing version of our product. Managed care
organisations typically favour generics over brand name drugs,
and governments encourage, or under some circumstances mandate,
the use of generic products, thereby reducing the sales of
branded products that are no longer patent protected.
Governmental and other pressures toward the dispensing of
generic products may rapidly and significantly reduce, or slow
the growth in, the sales and profitability of any of our
products not protected by patents or regulatory exclusivity and
may adversely affect our future results and financial condition.
The launch of competitive products, including generic versions
of our products, has had and will have a material and adverse
affect on our revenues and results of operations.
Our competitive position depends, in part, upon our continuing
ability to discover, acquire and develop innovative,
cost-effective new products, as well as new indications and
product improvements protected by patents and other intellectual
property rights. We also compete on the basis of price and
product differentiation and through our sales and marketing
organisation. If we fail to maintain our competitive position,
then our revenues and results of operations may be materially
adversely affected.
This excerpt taken from the ELN 20-F filed Feb 28, 2008. Our
industry and the markets for our products are highly
competitive.
The pharmaceutical industry is highly competitive. Our principal
pharmaceutical competitors consist of major international
companies, many of which are larger and have greater financial
resources, technical staff, manufacturing, R&D and
marketing capabilities than Elan. We also compete with smaller
research companies and generic drug manufacturers.
A drug may be subject to competition from alternative therapies
during the period of patent protection or regulatory exclusivity
and, thereafter, it may be subject to further competition from
generic products. The price of pharmaceutical products typically
declines as competition increases.
Our product Azactam lost its basic U.S. patent
protection in October 2005. To date, no generic Azactam
product has been approved.
In addition, the U.S. basic patent covering our product
Maxipime expired in March 2007. Maxipime became
subject to generic competition following the expiration of the
basic patent, and that has materially and adversely affected our
sales of Maxipime.
Generic competitors have challenged existing patent protection
for several of the products from which we earn manufacturing or
royalty revenue. If these challenges are successful, our
manufacturing and royalty revenue will be materially and
adversely affected.
Generic competitors do not have to bear the same level of
R&D and other expenses associated with bringing a new
branded product to market. As a result, they can charge much
less for a competing version of our product. Managed care
organizations typically favor generics over brand name drugs,
and governments encourage, or under
Table of Contents
some circumstances mandate, the use of generic products, thereby
reducing the sales of branded products that are no longer patent
protected. Governmental and other pressures toward the
dispensing of generic products may rapidly and significantly
reduce, or slow the growth in, the sales and profitability of
any of our products not protected by patents or regulatory
exclusivity and may adversely affect our future results and
financial condition. The launch of competitive products,
including generic versions of our products, has had and will
have a material and adverse affect on our revenues and results
of operations.
Our competitive position depends, in part, upon our continuing
ability to discover, acquire and develop innovative,
cost-effective new products, as well as new indications and
product improvements protected by patents and other intellectual
property rights. We also compete on the basis of price and
product differentiation and through our sales and marketing
organization. If we fail to maintain our competitive position,
then our revenues and results of operations may be materially
adversely affected.
This excerpt taken from the ELN 6-K filed Mar 30, 2007. Our
industry and the markets for our products are highly
competitive.
The pharmaceutical industry is highly competitive. Our principal
pharmaceutical competitors consist of major international
companies, many of which are larger and have greater financial
resources, technical staff, manufacturing, R&D and marketing
capabilities than Elan. We also compete with smaller research
companies and generic drug manufacturers.
A drug may be subject to competition from alternative therapies
during the period of patent protection or regulatory exclusivity
and, thereafter, it may be subject to further competition from
generic products. The price of pharmaceutical products typically
declines as competition increases.
Our product Azactam lost its basic US patent protection
in October 2005. We expect that Azactam will be subject
to generic competition in 2007 and that our sales of Azactam
will be materially and adversely affected by such generic
competition. However, to date, no generic Azactam product
has been approved.
In addition, the US basic patent covering our product
Maxipime for injection expired in March 2007. Two
formulation US patents covering Maxipime expire in
February 2008. Bristol-Myers recently received correspondence
from lawyers for Apotex stating that Apotex intends to enter the
US market with Apotex’s cefepime hydrochloride upon
receiving approval from the FDA. Bristol-Myers has requested
additional information from Apotex to determine if Apotex’s
form of cefepime hydrochloride, if approved by the FDA,
infringes Bristol-Myers patents. If Apotex or others are able to
introduce generic competitors to Maxipime our revenues
from, and gross margin for, Maxipime will be materially
and adversely affected.
Generic competitors may also challenge existing patent
protection or regulatory exclusivity. Generic competitors do not
have to bear the same level of R&D and other expenses
associated with bringing a new branded product to market. As a
result, they can charge much less for a competing version of our
product. Managed care organisations typically favour generics
over brand name drugs, and governments encourage, or under some
circumstances mandate, the use of generic products, thereby
reducing the sales of branded products that are no longer patent
protected. Governmental and other pressures toward the
dispensing of generic products may rapidly and significantly
reduce, or slow the growth in, the sales and profitability of
any of our products not protected by patents or regulatory
exclusivity and may adversely affect our future results and
financial condition. The launch of competitor products,
including generic versions of our products, may materially
adversely affect us.
Our competitive position depends, in part, upon our continuing
ability to discover, acquire and develop innovative,
cost-effective new products, as well as new indications and
product improvements protected by patents and other intellectual
property rights. We also compete on the basis of price and
product differentiation and through our sales and marketing
organisation. If we fail to maintain our competitive position,
then we may be materially adversely affected.
This excerpt taken from the ELN 20-F filed Feb 28, 2007. Our
industry and the markets for our products are highly
competitive.
The pharmaceutical industry is highly competitive. Our principal
pharmaceutical competitors consist of major international
companies, many of which are larger and have greater financial
resources, technical staff, manufacturing, R&D and marketing
capabilities than Elan. We also compete with smaller research
companies and generic drug manufacturers.
A drug may be subject to competition from alternative therapies
during the period of patent protection or regulatory exclusivity
and, thereafter, it may be subject to further competition from
generic products. The price of pharmaceutical products typically
declines as competition increases.
Our product Azactam lost its basic US patent protection
in October 2005. We expect that Azactam will be subject
to generic competition in 2007 and that our sales of Azactam
will be materially and adversely affected by such generic
competition. However, to date, no generic Azactam product
has been approved.
Table of Contents
In addition, the US basic patent covering our product
Maxipime for injection expires in March 2007. Two
formulation US patents covering Maxipime expire in
February 2008. Maxipime may become subject to generic
competition following the expiration of the basic patent or
after expiration of the formulation patents and that would
materially and adversely affect our sales of Maxipime.
Generic competitors may also challenge existing patent
protection or regulatory exclusivity. Generic competitors do not
have to bear the same level of R&D and other expenses
associated with bringing a new branded product to market. As a
result, they can charge much less for a competing version of our
product. Managed care organizations typically favor generics
over brand name drugs, and governments encourage, or under some
circumstances mandate, the use of generic products, thereby
reducing the sales of branded products that are no longer patent
protected. Governmental and other pressures toward the
dispensing of generic products may rapidly and significantly
reduce, or slow the growth in, the sales and profitability of
any of our products not protected by patents or regulatory
exclusivity and may adversely affect our future results and
financial condition. The launch of competitor products,
including generic versions of our products, may materially
adversely affect us.
Our competitive position depends, in part, upon our continuing
ability to discover, acquire and develop innovative,
cost-effective new products, as well as new indications and
product improvements protected by patents and other intellectual
property rights. We also compete on the basis of price and
product differentiation and through our sales and marketing
organization. If we fail to maintain our competitive position,
then we may be materially adversely affected.
This excerpt taken from the ELN 6-K filed Mar 31, 2006. Our industry and the markets for our
products are highly competitive.
The pharmaceutical industry is highly competitive. Our principal
pharmaceutical competitors consist of major international
companies, many of whom are larger and have greater financial
resources, technical staff, manufacturing, R&D and marketing
capabilities than Elan. We also compete with smaller research
companies and generic drug manufacturers.
A drug may be subject to competition from alternative therapies
during the period of patent protection or regulatory exclusivity
and, thereafter, it may be subject to further competition from
generic products. The price of pharmaceutical products typically
declines as competition increases.
Our product Azactam lost its basic U.S. patent
protection in October 2005. We expect that Azactam will
be subject to generic competition in 2006 and that our sales of
Azactam will be materially and adversely affected by such
generic competition. However, to date, no generic Azactam
product has been approved.
Generic competitors may also challenge existing patent
protection or regulatory exclusivity. Generic competitors do not
have to bear the same level of R&D and other expenses
associated with bringing a new branded product to market. As a
result, they can charge much less for a competing version of our
product. Managed care organisations typically favour generics
over brand name drugs, and governments encourage, or under some
circumstances mandate, the use of generic products, thereby
reducing the sales of branded products that are no longer patent
protected. Governmental and other pressures toward the
dispensing of generic products may rapidly and significantly
reduce, or slow the growth in, the sales and profitability of
any of our products not protected by patents or regulatory
exclusivity and may adversely affect our future results and
financial condition. The launch of competitor products,
including generic versions of our products, may materially
adversely affect us.
Our competitive position depends, in part, upon our continuing
ability to discover, acquire and develop innovative,
cost-effective new products, as well as new indications and
product improvements protected by patents and other intellectual
property rights. We also compete on the basis of price and
product differentiation and through our sales and marketing
organisation. If we fail to maintain our competitive position,
then we may be materially adversely affected.
This excerpt taken from the ELN 20-F filed Mar 30, 2006. Our
industry and the markets for our products are highly
competitive.
The pharmaceutical industry is highly competitive. Our principal
pharmaceutical competitors consist of major international
companies, many of whom are larger and have greater financial
resources, technical staff, manufacturing, R&D and marketing
capabilities than Elan. We also compete with smaller research
companies and generic drug manufacturers.
A drug may be subject to competition from alternative therapies
during the period of patent protection or regulatory exclusivity
and, thereafter, it may be subject to further competition from
generic products. The price of pharmaceutical products typically
declines as competition increases.
Our product
Azactamtm
(aztreonam for injection, USP) lost its basic
U.S. patent protection in October 2005. We expect that
Azactam will be subject to generic competition in 2006
and that our sales of Azactam will be materially and
adversely affected by such generic competition. However, to
date, no generic Azactam product has been approved.
Generic competitors may also challenge existing patent
protection or regulatory exclusivity. Generic competitors do not
have to bear the same level of R&D and other expenses
associated with bringing a new branded product to market. As a
result, they can charge much less for a competing version of our
product. Managed care organizations typically favor generics
over brand name drugs, and governments encourage, or under some
circumstances mandate, the use of generic products, thereby
reducing the sales of branded products that are no longer patent
protected. Governmental and other pressures toward the
dispensing of generic products may rapidly and significantly
reduce, or slow the growth in, the sales and profitability of
any of our products not protected by
Table of Contents
patents or regulatory exclusivity and may adversely affect our
future results and financial condition. The launch of competitor
products, including generic versions of our products, may
materially adversely affect us.
Our competitive position depends, in part, upon our continuing
ability to discover, acquire and develop innovative,
cost-effective new products, as well as new indications and
product improvements protected by patents and other intellectual
property rights. We also compete on the basis of price and
product differentiation and through our sales and marketing
organization. If we fail to maintain our competitive position,
then we may be materially adversely affected.
This excerpt taken from the ELN 6-K filed Apr 11, 2005. Our industry and the markets for our products are highly competitive. The pharmaceutical industry is highly competitive. Our principal pharmaceutical competitors consist of major international companies, many of whom are larger and have greater financial resources, technical staff, manufacturing, R&D and marketing capabilities than Elan. Other competitors also consist of smaller research companies and generic drug manufacturers. A drug may be subject to competition from alternative therapies during the period of patent protection or regulatory exclusivity and, thereafter, it may be subject to further competition from generic products. The price of pharmaceutical products typically declines as competition increases. Generic competitors may also challenge existing patent protection or regulatory exclusivity. Generic competitors do not have to bear the same level of R&D and other expenses associated with bringing a new branded product to market. As a result, they can charge much less for a competing version of our product. Managed care organisations typically favour generics over brand name drugs, and governments encourage, or under some circumstances mandate, the use of generic products, thereby reducing the sales of branded products that are no longer patent protected. Governmental and other pressures toward the dispensing of generic products may rapidly and significantly reduce, or slow the growth in, the sales and profitability of any of our products not protected by patents or regulatory exclusivity and may adversely affect our future results and financial condition. The launch of competitor products, including generic versions of our products, may materially adversely affect us. Our competitive position depends, in part, upon our continuing ability to discover, acquire and develop innovative, cost-effective new products, as well as new indications and product improvements protected by patents and other intellectual property rights. We also compete on the basis of price and product differentiation and through our sales and marketing organisation. If we fail to maintain our competitive position, then we may be materially adversely affected. | EXCERPTS ON THIS PAGE:
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