Dexmedetomidine hydrochloride (Precedex) 100 mcg base/ml: Innovator sued Sandoz

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

Bivalirudin (Angiomax) 250 mg/vial IV injection: Innovator confirmed receipt of Paragraph IV notice letter from Teva and Pliva

The innovator, M/S Medicines Company announced (in a press release Here) that it has received Paragraph IV Certification notice letters from generic players M/S Teva Parenteral and M/S Pliva wherein, generic players informed the Company that they have submitted Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration (USFDA) for approval to market generic versions of anti-clotting formulation Bivalirudin (Angiomax) 250 mg/vial IV injection.

The following patents are listed for this product:

US5196404 (Expiry: Sep 23, 2010): Which covers Bivalirudin as product

US7582727 (Expiry: Jan 27, 2029): Which covers pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID NO: 1) and mannitol for use as an anticoagulant in a subject in need thereof, wherein the batches have a pH adjusted by sodium hydroxide, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum reconstitution time that does not exceed about 42 seconds and a maximum total impurity level that does not exceed about 2% as measured by HPLC.

The generic players have filed Para IV against ‘727 (Earlier, innovator announced grant of ‘727 patent Here). Probably, generic players have filed ANDA with Para III against ‘404 patent.

Earlier, innovator got final approval to market Bivalirudin (Angiomax) 250 mg/vial IV injection from USFDA on Dec 15, 2000.