Innovator Orion Corporation has confirmed (in a press release Here) that generic player Sandoz has filed ANDA with Paragarph IV certification against Orange Book listed patents for Dexmedetomidine hydrochloride 100 mcg base/ml (Precedex) injection.
following Orange Book listed patents for Dexmedetomidine hydrochloride 100 mcg base/ml (Precedex) injection:
US5344840 (Expiry: Sep 6, 2011): Which covers a method of perioperative treatment of mammals to reduce the responses of the autonomic nervous system to stressful stimuli during an operation by administering to said mammal in whom such reduction is desired an effective amount of dextro 4-[1-(2,3-dimethylpheny)-ethyl] -1H-imidazole or a non-toxic pharmaceutically acceptable salt thereof substantially in the absence of the laevo form of said compound.
US4910214 (Expiry: Jul 15, 2013): which covers The d enantiomer of medetomidine or a non-toxic pharmaceutically acceptable acid addition salt thereof.
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.
The generic player Sandoz's has challenged ‘214 and ‘876 patent.
The USFDA approved NDA for this product on Dec 17, 1999
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