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The cash is going to drive it." "It's simply frustrating to believe that there's something that could be helping people and we're not using it," said Dr. Nancy Rigotti, director of the Tobacco Treatment Unit at Massachusetts General Health Center. A natural item like cytisine can not be patented. That makes its market position more difficult to defend.

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Drug business state the expense of developing and getting approval for a new drug is $1 billion. This might explain why some business have actually seen smash hit revenues with treatments for rare illness, such as Genzyme's drug for Goucher disease, which costs $300,000 a year. "They're fixated on patent protection and brand-new drugs," Stewart stated.

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One is the limited cytisine supply. A competitor would need to plant vast orchards of laburnum trees hundreds of countless them and wait 4 years before the drug-containing seeds might be collected. The other thing is that Extab is new to the U.S. market. Nobody has ever tried to get it approved.

market exclusivity as an unique drug under the 1984 Hatch-Waxman Act.  smoking benefits 's less than the common 20-year window for patented medicines. But it's something. "It's a truly old, unique drug," Stewart states. Still, he required assistance getting the drug through the U.S. regulatory labyrinth. He required to get lucky. And he did.

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In 2011, the findings were published in the New England Journal of Medication, showing cytisine was 3. 4 times most likely than placebo to assist individuals give up smoking and stay that way for one year, on par with Chantix. Then a review by University of Sheffield scientists compared cytisine with Chantix and concluded that while more examination was needed, "Cytisine is estimated to be both more scientifically effective and cost-efficient than (Chantix)." However the genuine turning point was available in December, when another study was released in the New England Journal of Medicine.