Purdue Pharma L.P. Announces Resolution of OxyContin® (oxycodone HCl
controlled-release) Tablets CII Patent Lawsuit with Actavis, Inc.
Actavis acknowledges infringement of Purdue patents and acquires license from
Purdue to sell generic versions of reformulated OxyContin starting as early as
STAMFORD, Conn., April 26, 2013
STAMFORD, Conn., April 26, 2013 /PRNewswire/ -- Purdue Pharma L.P. and
Actavis, Inc. announced today that the companies have agreed to resolve the
patent infringement lawsuits between them now pending in the United States
District Court for the Southern District of New York concerning certain Purdue
patents, including patents for abuse-deterrent technology, protecting
OxyContin® (oxycodone HCl controlled-release) Tablets CII ("OxyContin").
According to the agreement, Actavis will acknowledge the validity and
enforceability of Purdue's patents and that their generic formulation of
OxyContin infringed those patents. In exchange, Purdue will grant a license
to Actavis to sell defined quantities of either a generic version or an
authorized generic version of reformulated OxyContin tablets starting as early
(Logo: http://photos.prnewswire.com/prnh/20100921/NY67262 )
"Today's agreement will promote competition and allow for availability of
generic formulations of reformulated OxyContin. At the same time, this
resolution relieves us of the risks, distractions and costs of continued
litigation. We are pleased that this matter has been resolved in a manner that
respects the inventions we have incorporated into the reformulated OxyContin
tablets," said John H. Stewart, president and CEO of Purdue. "Our dedication
to serving both healthcare professionals and patients with innovative
prescription and non-prescription products has never waned and we look forward
to maintaining that commitment."
The professional product labeling for OxyContin^® Tablets contains the
following Boxed Warning:
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and
OxyContin^® contains oxycodone, an opioid agonist and Schedule II controlled
substance with an abuse liability similar to other opioid agonists, legal or
illicit [see Warnings and Precautions (5.1)]. Assess each patient's risk for
opioid abuse or addiction prior to prescribing OxyContin. The risk for opioid
abuse is increased in patients with a personal or family history of substance
abuse (including drug or alcohol abuse or addiction) or mental illness (e.g.,
major depressive disorder). Routinely monitor all patients receiving
OxyContin for signs of misuse, abuse, and addiction during treatment [see Drug
Abuse and Dependence (9)].
Life-Threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of
OxyContin, even when the drug has been used as recommended and not misused or
abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are
essential and OxyContin should be prescribed only by healthcare professionals
who are knowledgeable in the use of potent opioids for the management of
chronic pain. Monitor for respiratory depression, especially during
initiation of OxyContin or following a dose increase. Instruct patients to
swallow OxyContin tablets intact. Crushing, dissolving, or chewing the tablet
can cause rapid release and absorption of a potentially fatal dose of
Accidental ingestion of OxyContin, especially in children, can result in a
fatal overdose of oxycodone [see Warnings and Precautions (5.3)].
Indications and Usage
OxyContin is indicated for the management of moderate to severe pain when a
continuous, around-the-clock opioid analgesic is needed for an extended period
Limitations of Use
OxyContin is not for use:
oAs an as-needed (prn) analgesic
oFor pain that is mild or not expected to persist for an extended period of
oFor acute pain
oIn the immediate postoperative period
oFor postoperative pain, unless the patient is already receiving chronic
opioid therapy prior to surgery, or if the postoperative pain is expected
to be moderate to severe and persist for an extended period of time
OxyContin 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a
total daily dose greater than 80 mg are only for patients in whom tolerance to
an opioid of comparable potency is established. Patients considered opioid
tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg
transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral
hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of
another opioid for one week or longer.
OxyContin is contraindicated in patients with:
oSignificant respiratory depression
oAcute or severe bronchial asthma in an unmonitored setting or in the
absence of resuscitative equipment
oKnown or suspected paralytic ileus and gastrointestinal obstruction
oHypersensitivity (e.g., anaphylaxis) to oxycodone
Additional Safety Information
Respiratory depression is the chief hazard of opioid agonists, including
OxyContin. Respiratory depression is more likely to occur in elderly,
cachectic, and debilitated patients, and patients with chronic pulmonary
disease; therefore closely monitor these patients.
Hypotension, and profound sedation, coma or respiratory depression may result
if OxyContin is used concomitantly with other CNS depressants (e.g.,
sedatives, anxiolytics, hypnotics, neuroleptics, muscle relaxants, other
opioids). When considering the use of OxyContin in a patient taking a CNS
depressant, assess the duration of use of the CNS depressant and the patient's
response, including the degree of tolerance that has developed to CNS
depression. If OxyContin therapy is to be initiated in a patient taking a CNS
depressant, start with a lower OxyContin dose than usual and monitor patients
for signs of sedation and respiratory depression and consider using a lower
dose of the concomitant CNS depressant.
Use caution when prescribing OxyContin for patients who have difficulty
swallowing or have underlying GI disorders that may predispose them to
obstruction. Instruct patients not to pre-soak, lick or otherwise wet
OxyContin Tablets prior to placing in the mouth, and to take one tablet at a
time with enough water to ensure complete swallowing immediately after placing
in the mouth.
OxyContin may increase the risk of serious adverse reactions such as those
observed with other opioid analgesics, including respiratory depression,
apnea, respiratory arrest, circulatory depression, hypotension, or shock. The
most common adverse reactions (>5%) reported by patients in clinical trials
comparing OxyContin with placebo are: constipation, nausea, somnolence,
dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating.
Full prescribing information for OxyContin^® is available at
Purdue Pharma L.P. and its associated U.S. companies are privately-held
pharmaceutical companies known for pioneering research on persistent pain.
Headquartered in Stamford, CT, Purdue is engaged in the research, development,
production, and distribution of both prescription and over-the-counter
medicines and hospital products. Additional information about Purdue can be
found at www.purduepharma.com.
SOURCE Purdue Pharma L.P.
Contact: Libby Holman, Associate Director, Public Affairs, Tel: 203-588-7670,
Cell: 203-609-1291, email@example.com or James Heins, Senior Director,
Public Affairs, Tel: 203-588-8069 or Cell: 203-856-2121, Email:
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