Orion and Hospira,Inc. sue Sandoz companies in the U.S. to enforce their U.S. Patents covering the proprietary drug Precedex

08-Sep-2009 - USA

Orion Corporation and Hospira, Inc. filed together a patent infringement lawsuit in the United States to enforce Orion's U.S. Patent No.4,910,214 and Orion's and Hospira's commonly owned U.S. Patent No. 6,716,867 against Sandoz International Gmbh and Sandoz Inc.

Sandoz Inc. seeks authorisation to produce and market a generic version of Precedex® (dexmedetomidine hydrochloride 100 mcg base/ml) in the United States. Precedex®, originated by Orion Corporation and marketed in the United States by Hospira, Inc., is approved for continuous intravenous sedation of initially intubated and mechanically ventilated patients in the intensive care setting for up to 24 hours and in non-intubated patients requiring sedation prior to and/or during surgical and other procedures.

As reported in July 2009, Orion Corporation was notified that Sandoz Inc. submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) that included a Paragraph IV challenge to above mentioned patents.

By suing to enforce its patents within 45 days from receipt of the Paragraph IV certification notice, Orion Corporation and Hospira, Inc. are entitled to an automatic stay prohibiting the FDA from approving the applicant's ANDA for 30 months, or until an earlier court decision adverse to Orion Corporation's and Hospira's patents in the infringement lawsuit. As such, the realisation of generic competition is neither certain nor imminent. Orion Corporation and Hospira, Inc. will defend the intellectual property rights covering Precedex.

https://www.bionity.com/en/news/105965/orion-and-hospira-inc-sue-sandoz-companies-in-the-u-s-to-enforce-their-u-s-patents-covering-the-proprietary-drug-precedex.html