These laws are expected to protect Provigil from generic competition until sometime in 2006.
Nearly half of total revenue comes from one drug, Provigil, a treatment for chronic sleepiness.
If a generic were to get through, a big chunk of Provigil's sales would vanish.
He also prescribed Provigil, a stimulant, and Vicodin, a painkiller with high amounts of acetaminophen.
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"Provigil is obviously the big drug and did the heavy lifting, " says Cephalon spokesman Robert W. Grupp.
One week later, generic drug company Apotex contacted Watson seeking a deal for the exclusive generic Provigil rights.
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By 2002, some analysts said 80% or more of Provigil sales were for treating indications other than narcolepsy.
Provigil could conceivably face cheap generic competition within a few years if a key patent doesn't hold up.
Additional trials are ongoing to see if Provigil eases the fatigue suffered by cancer patients, or lightens persistent depression.
Never mind that Provigil, a brand name for modafinil, was not supposed to treat ADHD in the first place.
Of course, a lot of that upside potential would evaporate if generics were to slice into Provigil's market share.
This means Provigil will not become generic this year, as many investors feared.
Traditional treatments for hypersomnia, including stimulants such as Provigil, have proven to be effective sometimes with conditions like narcolepsy.
Cephalon has a fantastic drug in Provigil, which is already a successful narcolepsy drug and will soon treat other illnesses.
Investors must decide for themselves how much of the upcoming loss of Provigil has been priced in at this point.
People using Provigil or Ritalin may eventually be found to have a legitimate but previously unknown need for the drug.
Many people already use Provigil to cope with night-shift work, jet lag and lack of sleep, and suffer few side-effects.
If Watson was the first to file an ANDA for a generic Provigil, the federal Hatch-Waxman law accords Watson certain exclusivity rights.
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Provigil is also being prescribed for such diseases as multiple sclerosis and Parkinson's disease, and for the fatigue associated with hepatitis C.
Take, for instance, ProVigil, which is used to treat excessive daytime sleepiness.
It looks like the market was so blinded by the huge opportunity ADHD provided that it didn't see all the other uses for Provigil.
For instance, one settlement with multiple generic firms is expected to give biotech Cephalon several extra years of sales of its wakefulness drug Provigil.
Cephalon is riding high on the prospects for Provigil, Sparlon and Nuvigil, a stay-awake drug that is effective for ten hours, compared with Provigil's six.
Taylor, also indicated that Provigil might be effective in treating ADHD.
Chakalis later developed a constellation of ailments including Stevens-Johnson syndrome, a life-threatening skin condition that can be caused by a variety of drugs including Provigil.
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In October 2002, Bank of America's King estimated that 17% or less of Provigil prescriptions went to patients suffering from narcolepsy--and that number has dropped further since then.
But Provigil has become much more than a narcolepsy medication.
Into July 2009, Apotex continued to press Watson for a deal, indicating at one point through an email that Apotex had previously been in touch with FTC about generic Provigil.
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The attention deficit hyperactivity disorder drug, which is already on the market for sleepiness under the name Provigil, had caused one possible case of Stevens-Johnson Syndrome, a rare skin reaction.
Although, not all drugs surpassed expectations as Nuvigil, their new sleep disorder drug intended to cushion sales once blockbuster sleep drug Provigil faces generic competition, failed to achieve growth targets.
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