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FDA approves a new, nonnarcotic sleep aid.(Clinical Rounds)
The Food and Drug Administration has approved a new, nonnarcotic therapy for insomnia, eszopiclone. Most sleep aids are approved for only short-term use of a week to 10 days, but eszopiclone can be safely prescribed for longer, according to the FDA.
Formerly known as Estorra and now called Lunesta, eszopiclone is a nonbenzodiazepine hypnotic that is a pyrrolopyrazine derivative of the cyclopyrrolone class. It is manufactured and sold by Sepracor Inc. of Marlborough, Mass.
In early spring, the company plans to start a $60 million print and broadcast direct-to-consumer advertising campaign, said Jonae Barnes, a Sepracor spokes-woman. Sepracor also plans to use its 1,250-person sales force to call on psychiatrists, primary care physicians, and hospitals, she added.
The company sees huge market potential, noting that $2.1 billion of prescription sleep aids are sold each year in the United States and that 100 million Americans have chronic or occasional insomnia.
The National Sleep Foundation found in its most recent annual poll in 2002 that almost 60% of adults have insomnia several nights a week or ...
- Sepracor Files Patent Infringement Lawsuit Against Eszopiclone ANDA Filers.
- Press release article from: Business Wire March 20, 2009 700+ words
...Paragraph IV certifications for generic copies of eszopiclone. Sepracor markets eszopiclone in the U.S. under the brand name LUNESTA([R]). The lawsuit alleges infringement of Sepracor's U.S. Patent Numbers 6,319,926; 6...
- Eisai Enters into In-licensing Agreement with Sepracor for Eszopiclone Insomnia...
- News wire article from: JCN Newswires July 27, 2007 700+ words
...Co., Ltd. and Sepracor Inc. signed an...insomnia treatment eszopiclone (product name...compound in Japan. Eszopiclone is a non-benzodiazepine...agonist discovered by Sepracor. With its short...United States, eszopiclone received approval...been marketed by Sepracor since April, ...
- Sepracor files patent infringement lawsuit against eszopiclone ANDA filers.
- News wire article from: Chemical Business Newsbase March 20, 2009 700+ words
Sepracor Inc has filed a lawsuit in the US District Court for the District...ANDAs) with Paragraph IV certifications for generic copies of eszopiclone. Sepracor markets eszopiclone in the US under the brand name Lunesta. The lawsuit alleges...
- Sepracor Announces Conditional Expansion of Eszopiclone Agreement.
- Press release article from: PR Newswire July 13, 2004 700+ words
...relating to eszopiclone, which is...developed by Sepracor for the treatment...assign to Sepracor the foreign...patent covering eszopiclone and its therapeutic...to assign Sepracor's obligation...on sales of eszopiclone in the U...
- Sepracor submits NDA for eszopiclone.
- Newspaper article from: Drug Week February 28, 2003 700+ words
...amp; NewsRx.net) -- Sepracor, Inc., (SEPR) announced...clearance to market Estorra (eszopiclone) 2 mg and 3 mg tablets for...particular significance is Sepracor's completion of what it...months. "We believe that Sepracor is the first company to successfully...
- Sepracor Announces Launch Timing for LUNESTA(TM) Brand Eszopiclone for...
- Press release article from: PR Newswire April 1, 2005 700+ words
...PRNewswire-FirstCall/ -- Sepracor Inc. today announced...that will designate eszopiclone as a Schedule IV controlled...of the final rule, Sepracor will commence full...LUNESTA(TM) brand eszopiclone. Sepracor expects LUNESTA to...
- Sepracor announces conditional expansion of eszopiclone agreement.
- News wire article from: Asia Africa Intelligence Wire July 13, 2004 700+ words
...agreement relating to eszopiclone, which is being developed by Sepracor for the treatment...registration of eszopiclone outside of the...would assign to Sepracor the foreign counterparts...patent covering eszopiclone and its therapeutic...
- European hypnotic benefits elderly insomniacs: investigational...
- Magazine article from: Family Practice News Sullivan, Michele G. January 1, 2004 700+ words
...week trial compared eszopiclone (Estorra, Sepracor Inc.) in two doses...effective." Other eszopiclone studies show no evidence...rebound insomnia. Sepracor Inc. (Marlborough...for Estorra brand eszopiclone to the Food and Drug...
- Sepracor and Eisai to sell eszopiclone in Japan.(Brief article)
- Newspaper article from: Pharma Marketletter August 6, 2007 700+ words
...based pharmaceutical company Sepracor has signed an agreement with...former's insomnia treatment eszopiclone, which is marketed in the...successfully commercialized. Sepracor, which is entitled to receive...currently receiving treatment. Sepracor said that the country's...
- Sepracor awarded US Patents for Estorra brand eszopiclone.
- News wire article from: Asia Africa Intelligence Wire February 11, 2003 700+ words
...Press Release) Sepracor Inc has been granted...of Estorra brand eszopiclone for the treatment...compositions containing eszopiclone. The natural term...Application (NDA), Sepracor would be permitted...product containing eszopiclone, the active ingredient...In Feb 2003, Sepracor ...
Source: HighBeam Research, FDA approves a new, nonnarcotic sleep aid.(Clinical Rounds)