Suddenly, Teva Pharmaceutical Industries ($TEVA) looks richer. Earlier this month, the FDA granted Teva dispensation to sell a generic version of Provigil, the blockbuster wakefulness drug, during the key 180-day exclusivity period. Its only generic competitor will be sold by Par Pharmaceutical ($PRX).
So, Teva can reap sales of branded Provigil, through its ownership of the drug's developer, Cephalon. And it can profit from a generic version, which will sell for higher prices during its first 6 months on the market because of limited competition.
It's sort of a completing-the-circle decision by the FDA: Par bought its Provigil generic rights from Teva. Antitrust regulators forced that sale, as a condition of the Teva-Cephalon merger, and the FTC deal allows Par early access to the market.
An Israeli analyst now thinks that Teva will increase its earnings guidance because of the new co-exclusivity rights. "Teva's estimates are looking conservative following the Provigil announcement," Natali Gotlieb told Bloomberg. "The exclusivity wasn't in Teva's guidance." She wouldn't hazard a guess about the size of that potential increase.
But Teva may well have to wait before nudging its financial goals upward. Mylan ($MYL) sued the FDA to challenge Teva's exclusivity rights, and applied for approval for its own version.
- read the Bloomberg story
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