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28 J O H N S O N & J O H N S O N 2 0 0 9 A N N U A L R E P O R T
first quarter of 2009. Prior to the acquisition of the joint venture
partner, sales by the joint venture were not recorded as part of the
Company’s sales to customers. The Oral Care franchise sales were
$1.6 billion, a decrease of 3.4% due to softness in the category in the
U.S., partially offset by growth of LISTERINE® mouthwash outside
the U.S. The Wound Care/Other franchise sales grew by 9.4% to
$1.1 billion primarily due to the recent acquisitions in the Wellness
and Prevention platform and strong sales of PURELL® hand sanitizer.
Consumer segment sales in 2008 were $16.0 billion, an
increase of 10.8% over 2007 with 8.3% of this change due to
operational growth and the remaining 2.5% due to positive currency
fluctuations. U.S. Consumer segment sales were $6.9 billion, an
increase of 8.3%. International sales were $9.1 billion, an increase of
12.8%, with 8.3% as a result of operations and 4.5% due to currency
fluctuations over 2007.
PHARMACEUTICAL SEGMENT
Pharmaceutical segment sales in 2009 were $22.5 billion, a
decrease of 8.3% from 2008, with an operational decline of 6.1%
and the remaining 2.2% due to the negative impact of currency fluc-
tuations. U.S. sales were $13.0 billion, a decrease of 12.1%. Interna-
tional sales were $9.5 billion, a decrease of 2.6%, which included
3.0% operational growth and a decrease of 5.6% resulting from the
negative impact of currency fluctuations.
REMICADE® (infliximab), a biologic approved for the treat-
ment of a number of immune mediated inflammatory diseases,
achieved sales of $4.3 billion in 2009, with growth of 14.8% over
the prior year primarily attributable to strong overall market growth.
REMICADE® is competing in a market which is experiencing
increased competition due to new entrants and the expansion of
indications for existing competitors.
PROCRIT® (Epoetin alfa) and EPREX® (Epoetin alfa) had com-
bined sales of $2.2 billion in 2009, a decline of 8.7% compared to
the prior year. Lower sales of PROCRIT® and EPREX® were due to
the declining markets for Erythropoiesis Stimulating Agents (ESAs).
LEVAQUIN® (levofloxacin)/FLOXIN® (ofloxacin) sales were
$1.6 billion, a decline of 2.6% versus the prior year, due to competi-
tion in the category. The patent for LEVAQUIN® (levofloxacin) in
the U.S. will expire in December 2010. A pediatric extension was
granted by the FDA, which extends market exclusivity in the U.S.
through June 2011. The expiration of the product patent or loss of
market exclusivity is likely to result in a significant reduction in sales.
RISPERDAL® CONSTA® (risperidone), a long-acting injectable
for the treatment of schizophrenia, achieved sales of $1.4 billion in
2009, representing an increase of 8.9% as compared to the prior
year. The growth was due to a positive shift from daily therapies to
longer-acting RISPERDAL® CONSTA® and the launch of
RISPERDAL® CONSTA® in Japan earlier in the year.
CONCERTA® (methylphenidate HCl), a product for the treat-
ment of attention deficit hyperactivity disorder (ADHD), achieved
sales of $1.3 billion in 2009, representing an increase of 6.3% over
2008. Sales results in 2008 were favorably impacted by approxi-
mately $115 million related to a change in the estimate of accrued
sales reserves related to sales outside the U.S. Although the original
CONCERTA® patent expired in 2004, the FDA has not approved any
generic version that is substitutable for CONCERTA®. Parties have
filed Abbreviated New Drug Applications (ANDAs) for generic ver-
sions of CONCERTA®, which are pending and may be approved at
any time. An approval would lead to a loss of exclusivity and is likely
to result in a significant reduction in sales.
TOPAMAX® (topiramate), RISPERDAL® (risperidone), and
DURAGESIC®/Fentanyl Transdermal (fentanyl transdermal system)
experienced sales declines in 2009 of 57.9%, 57.7% and 14.3%,
respectively, versus the prior year due to generic competition. Mar-
ket exclusivity in the U.S. expired for TOPAMAX® (topiramate) in
March 2009, RISPERDAL® oral in June 2008 and DURAGESIC® in
January 2005.
ACIPHEX®/PARIET® (rabeprazole sodium) experienced a
sales decline of 5.4% due to competition in the category.
In 2009, Other Pharmaceutical sales were $7.6 billion, repre-
senting a growth of 6.6% over the prior year. Contributors to the
increase were sales of VELCADE® (bortezomib), a product for the
treatment of multiple myeloma; PREZISTA® (darunavir), for the
treatment of HIV/AIDS patients; INTELENCE™ (etravirine), for HIV
combination therapy and INVEGA® (paliperidone), a once-daily
atypical antipsychotic. The growth was partially offset by the impact
of a generic version of ORTHO TRI-CYCLEN® LO shipped by a
competitor. Subsequently, the generic manufacturer recognized
the validity of the patent, paid damages for its infringing sales and
ceased further shipments of the product.
During 2009, the Company received regulatory approval for
several new molecular entities (NMEs), including STELARA
(ustekinumab) in the U.S. and European Union (EU) for the treat-
ment of moderate-to-severe plaque psoriasis; INVEGA®
SUSTENNA™ (paliperidone palmitate) extended-release injectable
suspension in the U.S. for the acute and maintenance treatment of
schizophrenia; SIMPONI™ (golimumab) in the U.S. and EU for the
treatment of moderate-to-severe, active rheumatoid arthritis (RA),
active and progressive psoriatic arthritis (PsA) and severe, active
ankylosing spondylitis (AS); and PRILIGY™ (dapoxetine) in several
countries for the on-demand treatment of premature ejaculation.
NUCYNTA™ (tapentadol) Immediate Release Tablets, for relief
of moderate to severe acute pain, was also launched in the U.S.
in 2009.
Major Pharmaceutical Product Revenues:
% Change
_____________________
(Dollars in Millions) 2009 2008 2007 ’09 vs. ’08 ’08 vs. ’07
REMICADE® (infliximab) $ 4,304 3,748 3,327 14.8% 12.7
PROCRIT®/EPREX® (Epoetin alfa) 2,245 2,460 2,885 (8.7) (14.7)
LEVAQUIN®/FLOXIN® (levofloxacin/ofloxacin) 1,550 1,591 1,646 (2.6) (3.3)
RISPERDAL® CONSTA® (risperidone) 1,425 1,309 1,128 8.9 16.0
CONCERTA® (methylphenidate HCl) 1,326 1,247 1,028 6.3 21.3
TOPAMAX® (topiramate) 1,151 2,731 2,453 (57.9) 11.3
ACIPHEX®/PARIET® (rabeprazole sodium) 1,096 1,158 1,357 (5.4) (14.7)
RISPERDAL® (risperidone) 899 2,126 3,420 (57.7) (37.8)
DURAGESIC®/Fentanyl Transdermal (fentanyl transdermal system) 888 1,036 1,164 (14.3) (11.0)
Other Pharmaceuticals 7,636 7,161 6,458 6.6 10.9
Total $22,520 24,567 24,866 (8.3)% (1.2)