Biotechs Sepracor and Neurocrine Biosciences have seen shares soar as investors have seen potential for their entrants.
Sleeping pills such as Ambien from Sanofi-Aventis and Lunesta from Sepracor have been some of most heavily advertised drugs.
Wall Street expects that neither Sepracor's Estorra nor Neurocrine's indiplon will have any limits on how long they can be taken.
Wockhardt also accused Sepracor of withholding a separate rat study from 1999 that contradicted its findings of low toxicity for the zopiclone isomer.
Each ANDA contained a Paragraph IV certification alleging that patents held by Sepracor covering aspects of the Lunesta drug were invalid or not infringed, according to the suit.
Sepracor said that Lunesta had been proven safe and effective over a six-month period in two different clinical studies, without evidence of patients becoming tolerant of the drug.
Sleeping pills such as Ambien from Sanofi-Aventis and Lunesta from Sepracor (nasdaq: SEPR - news - people ) have been some of most heavily advertised drugs.
Judge Cavanaugh said Wockhardt had failed to show that Sepracor knew the information was false, and that patent examiners had the data in front of them and could have drawn their own conclusions.
In December, Sepracor's Lunesta became the first sleeping pill approved without a restriction, limiting its use for a week or so, on its label. (Ambien has such a limitation, though many doctors prescribe it for longer.) Indiplon, being developed by Neurocrine and Pfizer, is likely to get similar labeling.
In December, Sepracor's Lunesta became the first sleeping pill approved without a restriction, limiting its use for a week or so, on its label. (Ambien has such a limitation, though many doctors prescribe it for longer.) Indiplon, being developed by Neurocrine and Pfizer (nyse: PFE - news - people ), is likely to get similar labeling.
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