Innovator Orion and Hospira has sued generic player Sandoz in the U.S. to enforce their U.S. Patents covering the proprietary drug Dexmedetomidine hydrochloride (Precedex) 100 mcg base/ml (as reported by orion in press release Here )
Orion Corporation and Hospira, Inc. filed together a patent infringement lawsuit in the United States to enforce following Orange Book listed patents:
US4910214 (Expiry: Jul 15, 2013 ): Which covers the d enantiomer of medetomidine or a non-toxic pharmaceutically acceptable acid addition salt thereof. The said patent also covers, a pharmaceutical composition suitable for use in a method of sedation/analgesia or treatment of anxiety or hypertension comprising the d-enantiomer of medetomidine or a non-toxic pharmaceutically acceptable acid addition salt thereof in an amount sufficient to produce the desired effect in association with a pharmaceutical carrier
US6716867 (Expiry: Mar 31, 2019): Which covers a method of sedating a patient in an intensive care unit, which comprises administering to the patient an effective amount of dexmedetomidine of a pharmaceutically acceptable salt thereof, wherein the patient remains arousable and orientated.
Dexmedetomidine hydrochloride (Precedex) 100 mcg base/ml 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.
Now, Sandoz's ANDA approval process would be delayed for 30 months as per Hatch-Waxman provisions.
Earlier news of IP Pharma Doc on this product Here
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