Innovator Sepracor announced (in a press release Here ) that it has filed a lawsuit in the U.S. District Court for the District of New Jersey against those companies who have filed abbreviated new drug applications (ANDAs) with Paragraph IV certifications for generic copies of Eszopiclone. Sepracor markets eszopiclone in the U.S. under the brand name LUNESTA®. The lawsuit alleges infringement of Sepracor’s following Orange Book listed patents for Eszopiclone 1 mg, 2 mg and 3 mg tablets:
US6,319,926 (Expiry: Jan 16, 2012): which covers a method for improving sleep quality or time comprising the step of administering an effective quantity of 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-d ihydro-5H-pyrrolo[3,4-b]pyrazine, or a pharmaceutically acceptable salt thereof, in the form of its dextrorotatory isomer and essentially free of its levorotatory isomer, to a human.
US6,444,673 (Expiry: Jan 16, 2012): Which covers 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-d ihydro-5H-pyrrolo[3,4-b]pyrazine, or a pharmaceutically acceptable salt thereof, in the form of its dextrorotatory isomer and essentially free of its levorotatory isomer.
US6864257 (Expiry: Aug 30, 2012): Which covers method of inducing an effect selected from the group consisting of a hypnotic effect, a sedative effect and a tranquilizing effect, in a human in need of said induction, comprising administering to the human an effective quantity of 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-d ihydro-5H-pyrrolo[3,4-b]pyrazine, or a pharmaceutically acceptable salt thereof, in the form of its dextrorotatory isomer and essentially free of its levorotatory isomer.
US7,381,724 (Expiry: Jan 16, 2012): Which covers mixture of isomers of 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyl-oxy]-7-oxo-6,7- -dihydro-5H-pyrrolo[3,4-b]pyrazine, wherein the mixture has an optical rotation [.alpha.].sub.D.sup.20 of 135.degree..+-.3.degree. when measured at 1.0 g/100 mL in acetone.
Due to the commencement of this litigation, ANDA approval will be stayed until approximately June 15, 2012 (or potentially six months thereafter if Sepracor successfully obtains a pediatric exclusivity extension) or until a court decides that Sepracor’s patents are invalid, unenforceable or not infringed, whichever is earlier.
US6,319,926 (Expiry: Jan 16, 2012): which covers a method for improving sleep quality or time comprising the step of administering an effective quantity of 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-d ihydro-5H-pyrrolo[3,4-b]pyrazine, or a pharmaceutically acceptable salt thereof, in the form of its dextrorotatory isomer and essentially free of its levorotatory isomer, to a human.
US6,444,673 (Expiry: Jan 16, 2012): Which covers 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-d ihydro-5H-pyrrolo[3,4-b]pyrazine, or a pharmaceutically acceptable salt thereof, in the form of its dextrorotatory isomer and essentially free of its levorotatory isomer.
US6864257 (Expiry: Aug 30, 2012): Which covers method of inducing an effect selected from the group consisting of a hypnotic effect, a sedative effect and a tranquilizing effect, in a human in need of said induction, comprising administering to the human an effective quantity of 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-d ihydro-5H-pyrrolo[3,4-b]pyrazine, or a pharmaceutically acceptable salt thereof, in the form of its dextrorotatory isomer and essentially free of its levorotatory isomer.
US7,381,724 (Expiry: Jan 16, 2012): Which covers mixture of isomers of 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyl-oxy]-7-oxo-6,7- -dihydro-5H-pyrrolo[3,4-b]pyrazine, wherein the mixture has an optical rotation [.alpha.].sub.D.sup.20 of 135.degree..+-.3.degree. when measured at 1.0 g/100 mL in acetone.
Due to the commencement of this litigation, ANDA approval will be stayed until approximately June 15, 2012 (or potentially six months thereafter if Sepracor successfully obtains a pediatric exclusivity extension) or until a court decides that Sepracor’s patents are invalid, unenforceable or not infringed, whichever is earlier.
Should Sepracor successfully enforce its patents, ANDA approval should not occur until expiration of the applicable patents, one of which may be extended by Sepracor’s outstanding patent term extension application.
Innovator Sepracor got approval from USFDA to market Eszopiclone (Lunasta) 1 mg, 2 mg and 3 mg tablets on Dec 15, 2004.
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