|[January 31, 2013]
Pfizer Wins RAPAMUNE® Patent Case in Delaware District Court
NEW YORK --(Business Wire)--
Pfizer Inc. said today that the United States District Court for the
District of Delaware ruled that Pfizer's patent covering a method for
using sirolimus, the active ingredient in RAPAMUNE®, for the inhibition
of organ transplant rejection is valid and infringed. The company
brought a patent infringement action in April 2010 against the generic
company Watson Laboratories, Inc-Florida (now known as Actavis) and
three other Watson entities after Watson applied to the FDA to market a
generic version of RAPAMUNE®. The Court's decision prevents Watson from
marketing its generic version of RAPAMUNE® in the U.S. before Pfizer's
patent expires, pending a possible appeal by Watson.
The patent at issue in the lawsuit is U.S. Patent No. 5,100,899, which
including pediatric exclusivity, expires January 7, 2014. In response to
the decision, Amy Schulman, Executive Vice President and General Counsel
for Pfizer, said, "We are pleased with the Court's decision, recognizing
the validity of our patent."
In the United States, RAPAMUNE® is indicated for the prevention of organ
transplant rejection in kidney transplant patients aged 13 years and
Important Safety Information
There is an increased risk of developing infections or certain
cancers, especially lymphoma and skin cancers. Rapamune
has not been shown to be safe and effective in people who have had
liver or lung transplants. Serious complications and death may happen
in people who take Rapamune after a liver or lung transplant. You
should not take Rapamune if you have had a liver or lung transplant
without talking with your doctor.
Do not take Rapamune if you know you are allergic to sirolimus or any
of the other ingredients in Rapamune. Symptoms of an allergic reaction
include swelling of your face, eyes, or mouth; trouble breathing or
wheezing; throat tightness; chest pain or tightness; feeling dizzy or
faint; and rash or peeling of your skin.
Before taking Rapamune, tell your doctor if you have liver problems,
skin cancer or it runs in your family, high cholesterol or
triglycerides, are breastfeeding or plan to breastfeed, and are
pregnant or plan to become pregnant. Women of childbearing potential
should use effective birth control before therapy, during therapy, and
for 12 weeks after Rapamune therapy has been stopped. Rapamune may
interact with oher medicines. Make sure that your doctor is aware of
all prescription and over-the-counter drugs that you are taking,
including vitamins, herbs, and nutritional supplements.
Rapamune may cause swelling in your hands, feet,
and in various tissues of your body. Call your doctor if you have
Rapamune may cause your wounds to heal slowly or
not heal well resulting in redness, drainage, or opening of the wound.
Rapamune may increase the levels of cholesterol and triglycerides
(lipids or fat) in your blood. Your doctor
should do blood tests to check your lipids during treatment with
Rapamune. Your doctor may recommend treatment if your lipid
levels become too high. Your lipid levels may
remain high even if you follow your prescribed treatment plan.
In patients taking Rapamune with cyclosporine, decreased kidney
function has been observed. Your doctor will regularly check your
Rapamune may increase protein in your urine. Your doctor may monitor
you for abnormal protein in your urine from time to time.
Rapamune may increase your risk for viral infections. Certain
viruses can live in your body and cause active infections when your
immune system is weak. One of these viruses, BK
virus, can affect how your kidney works and cause your transplanted
kidney to fail. A certain virus can cause a rare serious brain
infection called Progressive Multifocal Leukoencephalopathy causing
death or severe disability.
Rapamune may cause potentially life-threatening
lung or breathing problems. Symptoms may include coughing, shortness
of breath, or difficulty breathing.
When Rapamune is taken with cyclosporine or
tacrolimus, you may develop a blood clotting problem resulting in
unexplained bleeding or bruising.
Common side effects associated with Rapamune include high blood
pressure, pain (including stomach and joint pain), diarrhea, headache,
fever, urinary tract infection, low red blood cell count (anemia),
nausea, and low platelet count (cells that help blood to clot). If you
experience any side effects, contact your doctor.
Indications and Usage
RAPAMUNE® (sirolimus) is indicated for the prevention of organ
rejection in kidney transplant patients aged 13 years or older. Blood
levels of sirolimus should be checked in all patients taking Rapamune.
In patients at low to moderate risk of acute rejection, it is
recommended that Rapamune be used initially in combination with
cyclosporine and corticosteroids; cyclosporine should be withdrawn
approximately 3 months after transplantation. Cyclosporine withdrawal
has not been studied in patients who have had severe acute rejection
prior to cyclosporine withdrawal, those who require dialysis or have a
high serum creatinine, Black patients, patients receiving a repeat
kidney transplant, patients receiving other transplanted organs
besides the kidney transplant, or patients with antibodies that may be
directed against the kidney transplant.
In patients at high risk of acute rejection (defined as Black
patients and/or patients receiving a repeat kidney transplant who lost
a previous kidney transplant from rejection and/or patients with high
levels of antibodies that may be directed against the kidney
transplant), it is recommended that Rapamune be used in combination
with cyclosporine and corticosteroids for the first year following
transplantation. The safety and efficacy of this combination in
high-risk patients have not been studied beyond one year; therefore,
after the first year, adjustments to the immunosuppressive regimen may
be considered by your doctor.
In pediatric patients, the safety and efficacy of Rapamune have
not been established in kidney transplant patients less than 13 years
old, or in patients less than 18 years old who are considered at high
risk of acute rejection.
The safety and efficacy of Rapamune without cyclosporine in newly
transplanted kidney patients have not been established.
The safety and efficacy of changing from either cyclosporine or
tacrolimus to Rapamune in maintenance kidney transplant patients have
not been established.
Please see full Prescribing Information for Rapamune, including Boxed
Warning and Medication Guide here.
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