2014

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 2014

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 as 2014.

(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 ACCIDENTAL EXPOSURE

Abuse Potential

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 increaseInstruct patients to swallow OxyContin tablets intact.  Crushing, dissolving, or chewing the tablet can cause rapid release and absorption of a potentially fatal dose of oxycodone.

Accidental Exposure

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 of time.

Limitations of Use

OxyContin is not for use:

  • As an as-needed (prn) analgesic
  • For pain that is mild or not expected to persist for an extended period of time
  • For acute pain
  • In the immediate postoperative period
  • For 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.

Contraindications

OxyContin is contraindicated in patients with:

  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected paralytic ileus and gastrointestinal obstruction
  • Hypersensitivity (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 www.purduepharma.com/OxyContinPI.

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.



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