Purdue, a biopharmaceutical
company has reached a settlement agreement on May 16, thereby ending a patent
dispute over Varam’s plans to make a generic version of Purdue’s OxyContin®
brand of oxycodone hydrochloride.
Case Filed: Aug 07, 2012
Case Closed: May 16, 2013
Judge: Sidney H. Stein
Court: New York Southern District Court
Other Plaintiffs: The P.F. Laboratories and Rhodes
Technologies
Other Defendant: KVK-Tech
Case Summary:
Purdue, current holder[i]
of NDA no. 20-553 (source: Patent Marker)
and the owner of the four patents covering the drug, OxyContin. It alleged that
Varam’s abbreviated new drug application for generic version of 10-, 15-, 20-,
30-, 60- and 80-milligram controlled-release tablets had infringed on their
patent rights. The patents are currently assigned[ii]
to Purdue (source: MaxVal’s Assignment
Database).
Purdue said Varam submitted an
abbreviated new drug application no. 20-1523 with the U.S. Food and Drug
Administration, seeking approval to manufacture and sell a generic version of
OxyContin, which is used to treat moderate to severe pain that is expected to
last for an extended period of time. According to the complaint, if allowed to
pursue its generic, Varam would infringe the following U.S. patents that
protect the branded pain reliever. The patents-in-suit are
·
US5508042 - Controlled release oxycodone
compositions, issued on Apr 16, 1996 and expired*
by Apr 16, 2013
·
US7674799 - Oxycodone hydrochloride having less
than 25 ppm 14-hydroxycodeinone, issued on Mar, 09, 2010 and expires* by Mar 30,
2025
·
US7674800 - Oxycodone hydrochloride having less
than 25 ppm 14-hydroxycodeinone, issued on Mar, 09, 2010 and expires* by Mar 30, 2025
·
US7683072 - Oxycodone hydrochloride having less
than 25 ppm 14-hydroxycodeinone, issued on Mar 23, 2010 and expires* by Mar 30,
2025
The case ended as the parties
have reached ‘Settlement Agreement’. The Court ordered that all the claims and
counterclaims to be dismissed with prejudice. At this point, there are no
further details available, on the terms of settlement.
See 1:12-cv-06047 for
more details. To get alerts on cases filed/closed,
subscribe to our Litigation Alerts.
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[i] Patent Marker provides an online
environment where patentees can virtually mark products and search products for
patent-related information.
[ii] MaxVal offers Patent Assignment Alert service where subscribers
receive email alerts when assignments relating to target applications, patents
or entities of interest are recorded.
* Expected expiration date. Patent Term
Estimator is a free
web-based tool that automatically calculates patent terms and expiration dates
for U.S. utility patent
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