Mallinckrodt acknowledges validity of Purdue patents; Purdue licenses
limited sales of some generic oxycodone strengths
STAMFORD, Conn., Sept. 2 /PRNewswire/ -- Purdue Pharma L.P. of Stamford, Connecticut and Mallinckrodt Inc. of Hazelwood, Missouri have agreed to end the OxyContin(R) (oxycodone HCl controlled-release) Tablets patent infringement lawsuit between them in the United States District Court for the Southern District of New York.
According to the agreement, Mallinckrodt acknowledges the validity and enforceability of Purdue's patents and admits that marketing generic versions of OxyContin under its Abbreviated New Drug Application (ANDA) without a license from Purdue would infringe these patents. In exchange, Purdue has agreed to grant Mallinckrodt a royalty-bearing license, ending in 2009, to sell limited quantities of generic versions of 10 mg, 20 mg, 40 mg, and 80 mg extended-release oxycodone tablets.
In the most recent decision in the litigation which Purdue and Mallinckrodt have now settled, the United States District Court for the Southern District of New York rejected claims that the Purdue patents were unenforceable because of Purdue's alleged inequitable conduct in obtaining them. In an Opinion and Order dated January 7, 2008, the Court stated, "There is no evidence of deceptive intent with respect to Purdue's failure to disclose prior controlled-release formulations or its failure to disclose [a Purdue scientist's] affiliations, both of which were made in good faith."
"We are pleased to resolve the dispute with Mallinckrodt in a manner that respects our inventions," said John H. Stewart, President of Purdue Pharma, in announcing the end of the lawsuit. "We will continue to defend our inventions against infringers."
Purdue Pharma is a privately-held pharmaceutical company 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 http://www.purduepharma.com.
The professional product labeling for OxyContin(R) Tablets contains the following boxed warning:
OxyContin is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.
Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.
OxyContin Tablets are NOT intended for use as a prn analgesic.
OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids.
OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.
Full prescribing information for OxyContin is available at http://www.purduepharma.com/PI/Prescription/Oxycontin.pdf .
|SOURCE Purdue Pharma L.P.|
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