Wednesday, October 23, 2013

Horizon, Par Resolve Patents Suits over Duexis Generic

Case Closed: Oct 17, 2013

Court: Delaware District Court

Judge: Leonard P. Stark

Case Summary:
Par resolved suits brought in by Horizon accusing the generic manufacturer of infringing its patents relating to treating arthritis. Judge granted the stipulation filed by the parties and dismissed the cases without prejudice, ending the litigations over Horizon’s abbreviated new drug application for a generic version of Duexis® infringing the ‘127, ‘202 and ‘033 patents covering the medication.

It appears that the Parties entered into settlement with licensing agreements, and Horizon has granted Par the non-exclusive right to market a generic ibuprofen and famotidine product in the US under Par's Abbreviated New Drug Application (ANDA), beginning January 1, 2023, or earlier under certain circumstances. Other details of the settlement were not disclosed.

Horizon filed complaints to protect three of its patents after Par submitted an ANDA no. 203658 to the U.S. Food and Drug Administration (FDA) for tablets containing 800 mg of ibuprofen and 26.6 mg of famotidine as active ingredients (a generic version of Duexis) by which it alleged that Par had committed an act of infringement. The court document said, unless a judge stops the alleged infringement, “Horizon will be irreparably harmed”. Horizon sought the court to declare a permanent enjoinment of Par from marketing and selling its generic version of Lotrel, as well as a court order that any approval of Par’s ANDA would not be effective until after expiration of the ‘127, ‘202 and ‘033 patents.

The patents in suits were: US8309127, US8318202 and US8067033 all entitled Stable compositions of famotidine and ibuprofen were issued on Nov 13, 2012, Nov 27, 2012 and Nov 29, 2011, respectively. The patents expire[*] by Nov 26, 2028 and are assigned to Horizon Pharma as per face page. As per the complaints, the ‘127 patent covers the Duexis® product and the '033 and '202 patent discloses a composition containing famotidine and ibuprofen.

Horizon’s Duexis is a combination drug used to treat signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers. Horizon currently holds[†] the new drug application no. 022519 for tablets, which contains 26.6 mg of famotidine and 800 mg of ibuprofen as active ingredients, which it sells under the brand name Duexis® (source: MaxVal’s Patent Marker) and approved by FDA on Apr 23, 2011.

See cases 1:13-cv-00102 and 1:12-cv-00393 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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[*] Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents.
[†] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

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