Navigation Links
Purdue Pharma L.P. Announces Resolution of OxyContin(R) Patent Lawsuit with Mallinckrodt Inc.

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

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.


Full prescribing information for OxyContin is available at .

SOURCE Purdue Pharma L.P.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Purdue leads center to simulate behavior of micro-electromechanical systems
2. Purdue creating wireless sensors to monitor bearings in jet engines
3. OncoGenex Pharmaceuticals announces out-license of TOCOSOL Paclitaxel to Eagle Pharmaceuticals
4. China Pharma Holdings, Inc. Will Attend the Susquehanna Financial Group, LLP (SIG) Beijing Management Summit
5. Amylin Pharmaceuticals to Present at Thomas Weisel Healthcare, BioCentury NewsMakers, and Morgan Stanley Global Healthcare Conferences
6. ViroPharma to Present at Three September Healthcare Conferences
7. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
8. Cadence Pharmaceuticals CEO Theodore Schroeder to Present at the 2008 NewsMakers In the Biotech Industry Conference
9. Trubion Pharmaceuticals to Present at Fall 2008 Morgan Stanley Global Healthcare Unplugged Conference in New York
10. Alexza Pharmaceuticals Announces Upcoming Webcasts and Conference Participation
11. Poniard Pharmaceuticals Announces Upcoming Conference Participation
Post Your Comments:
(Date:11/25/2015)... -- Studies reveal the differences in species ... the way for more effective treatment for one of the ... --> --> Gum disease ... cats, yet relatively little was understood about the bacteria associated ... conducted by researchers from the WALTHAM Centre for Pet Nutrition ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... the Organization of Black Aerospace Professionals (OPBAP) has been formalized with the signing ... AMA team leaders met with OPBAP leaders Capt. Karl Minter and Capt. Albert ...
(Date:11/24/2015)... , Nov. 24, 2015  Asia-Pacific (APAC) ... research organisation (CRO) market. The trend of outsourcing ... lower margins but higher volume share for the ... and scale, however, margins in the CRO industry ... (CRO) Market ( ), finds that ...
(Date:11/24/2015)... VANCOUVER , Nov. 24, 2015 /CNW/ - iCo ... ICOTF), today reported financial results for the quarter ... are expressed in Canadian dollars and presented under ... the United States ," said Andrew ... "These advancements regarding iCo-008 are not only value ...
Breaking Biology Technology:
(Date:10/26/2015)... India , October 26, 2015 ... --> adds ... 2015 to 2021 as well as ... 2015-2019 research reports to its collection ... . --> ...
(Date:10/23/2015)... Research and Markets ( ) has ... Biometrics Market 2015-2019" report to their offering. ... global voice recognition biometrics market to grow at a ... --> --> The report, Global Voice ... an in-depth market analysis with inputs from industry experts. ...
(Date:10/22/2015)... (NASDAQ: SYNA ), a leading developer of human interface solutions, ... 2015. --> --> Net ... over the comparable quarter last year to $470.0 million. Net income ... $0.62 per diluted share. --> ... 2016 grew 39 percent over the prior year period to $56.9 ...
Breaking Biology News(10 mins):